BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM

    MDR report key: 4182077 · Received October 17, 2014

    Report

    Report Number
    2024168-2014-06776
    Event Type
    Malfunction
    Date Received
    October 17, 2014
    Date of Event
    August 26, 2014
    Report Date
    September 10, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 DEVICE WAS RETURNED FOR EVALUATION. THE REPORTED DIFFICULTY REMOVING THE PROTECTIVE SHEATHS COULD NOT BE REPLICATED IN A TESTING ENVIRONMENT DUE TO THE CONDITION OF THE RETURNED DEVICE. ANALYSIS OF THE RETURNED DRUG ELUTING CORONARY DEVICE NOTED NO BLOOD OR CONTRAST VISIBLE. THE UNDAMAGED SCAFFOLD WAS STATIONARY ON THE TIGHTLY FOLDED BALLOON WHERE IT WAS INITIALLY CRIMPED ON. THE BALLOON WAS BUNCHED AT THE DISTAL BALLOON SHOULDER AND THE DISTAL BALLOON TAPER. THE BALLOON WAS SEPARATED FROM THE OUTER MEMBER AT THE DISTAL END OF THE PROXIMAL BALLOON SEAL BUT THE INNER MEMBER WAS STILL INTACT. THE DEVICE WAS NOT SEPARATED INTO TWO PIECES. BASED ON VISUAL AND DIMENSIONAL ANALYSIS OF THE RETURNED 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. THE RESULTS OF THE QUERY OF SIMILAR INCIDENTS IN THE COMPLAINT HANDLING DATABASE FOR THIS LOT DID NOT INDICATE A MANUFACTURING ISSUE. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DRUG ELUTING CORONARY DEVICE WAS STUCK TO THE PROTECTIVE SHEATH. UPON DEVICE RETURN, THE DEVICE WAS SET ASIDE FOR RETURN, AND NOT USED. THERE WAS NO PATIENT INVOLVEMENT. THERE WAS NO ADDITIONAL INFORMATION PROVIDED. RETURNED DEVICE ANALYSIS FOUND THAT THE BALLOON HAD SEPARATED FROM THE OUTER MEMBER AT DISTAL END OF PROXIMAL BALLOON. THE INNER MEMBER WAS STILL INTACT. THE PROXIMAL BALLOON SHAFT AND THE OUTER MEMBER WERE JAGGED AT THE SEPARATION AND THE BALLOON WAS BUNCHED AT THE DISTAL BALLOON SHOULDER AND THE DISTAL BALLOON TAPER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    661216 ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 4030761

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR