BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3011725 · Received March 19, 2013

    Report

    Report Number
    2024168-2013-01588
    Event Type
    Injury
    Date Received
    March 19, 2013
    Date of Event
    February 23, 2013
    Report Date
    February 23, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT IS INDICATED THAT THE DEVICE IS NOT RETURNING FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. 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 A 3.5X18 XIENCE V RX STENT DELIVERY SYSTEM (SDS) WAS UNPACKAGED FROM A SEALED CHIPBOARD BOX AND FROM A SEALED FOIL POUCH AND SEALED INNER TYVEK POUCH. THE 3.5X18 XIENCE V RX SDS WAS THEN ADVANCED VIA RADIAL ACCESS AND WAS DEPLOYED IN A LESION IN THE MID RIGHT CORONARY ARTERY (RCA). A 3.5X18 UNSPECIFIED BALLOON DILATATION CATHETER (BDC) WAS THEN ADVANCED TO PERFORM ROUTINE POST-DILATATION OF THE STENT WHEN IT WAS NOTED DURING BALLOON INFLATION THAT THE BALLOON LENGTH WAS NOTICEABLY LONGER THAN THE IMPLANTED STENT LENGTH; THE IMPLANTED STENT WAS ACTUALLY A 3.5X15 SIZE. THE BDC WAS WITHDRAWN FROM THE STENT AND ANATOMY, THEN THE XIENCE V DEVICE PACKAGING AND XIENCE V SDS WERE EACH INSPECTED, REVEALING THE FOLLOWING LABELING DISCREPANCY: CHIPBOARD BOX: 3.5X18 SIZE, LOT NUMBER 2022041, SERIAL NUMBER (B)(4). FOIL POUCH, INNER TYVEK POUCH, AND DEVICE HUB: 3.5X15 SIZE, LOT NUMBER 2030541, SERIAL NUMBER (B)(4) . THOUGH THE ACTUAL STENT LENGTH (3.5X15) WAS SHORTER THAN THE LABELED 3.5X18 LENGTH ON THE CHIPBOARD BOX, THE PROCEDURE WAS CONSIDERED COMPLETED AS NO PART OF THE LESION WAS LEFT UNTREATED. THERE WERE NO ADVERSE PATIENT SEQUELAE AND NO OCCURRENCE OF A CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114703 XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 2022041

    Patients

    Seq Age Sex Outcome Treatment
    1 DILATATION CATHETER: 3.5X18 UNSPECIFIED BALLOON