BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM

    MDR report key: 3090403 · Received May 2, 2013

    Report

    Report Number
    2024168-2013-02723
    Event Type
    Malfunction
    Date Received
    May 2, 2013
    Date of Event
    April 5, 2013
    Report Date
    April 6, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SERIAL NUMBER-CORRECTION. EVALUATION SUMMARY: THE COMPLAINT DEVICE WAS RETURNED FOR ANALYSIS. THE PROXIMAL BALLOON SEAL WAS SEPARATED. THE REPORTED INFLATION ISSUE COULD NOT BE REPLICATED AS THE RETURNED DEVICE WAS NOT RETURNED IN A CONDITION IN WHICH THE TEST COULD BE PERFORMED. BASED ON THE VISUAL ANALYSIS OF THE DEVICE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. A REVIEW OF THE COMPLAINT HISTORY OF THE REPORTED LOT DID NOT INDICATE A MANUFACTURING ISSUE. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. THOUGH THE DEVICE IS NOT APPROVED FOR SALE IN THE U.S., IT USES A DELIVERY SYSTEM WHICH IS SIMILAR TO A DEVICE SOLD IN THE U.S. THE PRODUCT CODE LISTED AND THE PMA# LISTED IS BASED ON THE PREDICATE DEVICE (XIENCE V STENT SYSTEM) THAT IS DETERMINED TO BE SAME AND SIMILAR TO THE DELIVERY SYSTEM OF THIS DEVICE.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    THE PROCEDURE WAS TO TREAT A DE NOVO, MILDLY TORTUOUS, NON-CALCIFIED, 95 PERCENT STENOSED LESION IN THE PROXIMAL PORTION OF THE LEFT ANTERIOR DESCENDING (PLAD) ARTERY. VIA A FEMORAL ACCESS SITE, PRE-DILATATION WAS PERFORMED WITH A TREK 2.5X20 MM BALLOON CATHETER AT 12 ATMOSPHERES AND A NON-ABBOTT NC 3.0X10 MM BALLOON CATHETER AT 16 ATMOSPHERES. DURING THE DEPLOYMENT OF THE 2.5X28 MM IMPLANT, THE BALLOON WAS NOT ABLE TO BE INFLATED EVEN AFTER REPEATED ATTEMPTS. THERE WAS NO RESISTANCE UPON REMOVING THE PROTECTIVE SHEATH. THE DELIVERY SYSTEM ALONG WITH THE IMPLANT WAS REMOVED FROM THE PATIENTS ANATOMY AND ANOTHER IMPLANT WAS USED. POST-DILATATION WAS PERFORMED WITH A NON-ABBOTT NC BALLOON CATHETER AT 16 ATMOSPHERES FOR 30 SECONDS. THERE WERE NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    191926 ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 2111361

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR GUIDE WIRE: RINATO, ROOT