A single damaged version of St. Jude Medical Inc. (STJ:US)’s Durata, a wire used to connect defibrillators to the heart, didn’t have the same flaw that prompted the recall of an older device last year, the company said.
St. Jude obtained access to the defective device that was removed from a patient in April and reported last month to the U.S. Food and Drug Administration, the company said in a statement. Its analysis showed the damage originated from the outside of the wire, known as a lead, not from a defect inside the insulated cable that could have frayed the life-saving wire.
St. Jude stopped selling its older Riata wires in 2010 and recalled them a year later amid reports the leads could break through the insulation in a defect known as “inside-out abrasion.” Durata replaced Riata, and the new product’s insulation coating was designed to prevent the complication. St. Paul, Minnesota-based St. Jude plunged 6 percent June 12 when details of a defective wire in a Durata device were posted in the FDA’s Maude database.
“The damage to the Durata lead is consistent with external abrasion from contact with a calcified, or hardened, heart valve or possibly from lead-to-lead contact,” St. Jude said in the statement. “External abrasion is a known cause of failure across all cardiac leads in the industry, which is different from the inside-out abrasion seen with externalized conductors observed in some Riata leads.”
There have been no reports of an inside-out externalized Durata wire, said Amy Jo Meyer, a St. Jude spokeswoman.
St. Jude gained (STJ:US) 2.9 percent to $39 at 4:47 p.m. New York time in extended trading, after increasing 2.6 percent to $37.90 at the close. The stock fell 22 percent in the past 12 months.
St. Jude said it was able to identify a Durata device that matched the serial number, implant and event dates reported to the FDA and provided to the company. The device was removed from the patient at a Florida hospital, which allowed St. Jude to review the patient’s records and X-rays and examine the device.
The patient previously had a different lead to connect a defibrillator to the heart. The older device had been de- activated and “capped,” though it remained inside the patient. The Durata device and the older lead crossed each other at the same location where the frayed wires were reported in the Maude database, the company said. A rubbing of the two wires could have caused the damage, St. Jude said.
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