Survivors of South Texas Man Call on FDA to Tighten Rules on Medical Devices

McALLEN, Texas -- The family of a McAllen businessman who died at the age of 49 after a medical device broke and went out of control during a routine heart procedure, called on the U.S. Food and Drug Administration today to tighten rules governing how medical equipment is approved.

The family of Isidro Cavazos, Jr., made the appeal after announcing settlement of a lawsuit against Boston Scientific Corporation, the maker of the device. Details were not disclosed.

A former policeman, border patrol agent and insurance agent, Cavazos died in 1999 following a procedure called an angioplasty, which is a surgical method for clearing blocked arteries. A tiny device called a Rotablator Rotational Atherectomy System, which is used to rotor the inside of blood vessels, lost its braking mechanism during the procedure, resulting in the uncontrolled slashing of Cavazos' heart tissue. The company has since pulled the device from the market.

Cavazos' widow urged the FDA to close a loophole that allowed Boston Scientific to modify the Rotablator device significantly in a way that affected patient safety and continue to market it without undergoing FDA scrutiny. Under current rules, if a manufacturer claims that a medical device is substantially similar to one that already has been approved, the FDA allows the device to be marketed without going through the FDA approval process.

"My husband died because of a loophole in the FDA's rules," said Isidro Cavazos' widow, Lisa. "We cannot bring him back, and our family will feel the void of his loss for the rest of our lives. But, we can try to keep other families from suffering the same kind of tragedy. That is why we will do everything possible to persuade the FDA to tighten its regulations regarding the approval of design changes in medical devices."

"We know what happens when the government allows those who make products to determine whether the products are safe," said Ricardo Garcia, the McAllen attorney who represented the Cavazos family. "It saves the companies money, but puts the rest of us at risk. The rules must be changed to protect consumers more thoroughly."

The specific device that broke during Cavazos' procedure, the Rotablator 20A, featured a two-piece automatic braking system. The original FDA-approved device featured a one-piece design with a manual brake that could be controlled by the cardiologist. Boston Scientific unilaterally deemed the new device to be substantially no different from the original device and did not submit it for FDA review.

"Manufacturers have a tremendous monetary interest in avoiding the FDA approval process because it is complicated and takes time, even though it is safer for consumers," Garcia noted. "The current FDA process is especially dangerous when a manufacturer finds a cheaper, less safe way to make a product and then takes advantage of the loophole."

Garcia said that the original FDA-approved version of the device cost Boston Scientific $6 per unit to make, compared to $1 per unit for the newer design. The company has been forced to withdraw the cheaper product from the market, but only after deaths and injuries brought the matter to the attention of the FDA, he said.

Cavazos underwent the coronary angioplasty procedure at a McAllen hospital on May 18, 1999. Performed under local anesthesia, the procedure is a surgical treatment designed to open blocked arteries by inflating a balloon in the artery and using a tiny rotating diamond-studded "burr" to remove blockage from artery walls. It is non-invasive and requires a minimal hospital stay.

During Cavazos' procedure, however, the brake on the Rotablator device failed. This caused the burr to break a solder connection, disconnecting a stiff guide wire which then rotated wildly, severely lacerating the heart tissues and causing extensive bleeding. By the time emergency surgery was performed, the damage to the heart tissues was irreparable, and Cavazos died on the operating table.

Isidro Cavazos, Jr., was an officer with the Harlingen police force from 1971 to 1976. He became a Border Patrol agent in 1976 and established a Farmers Insurance office in McAllen in 1978.

Source: Law Office of Ricardo A. Garcia