BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM

    MDR report key: 3250036 · Received July 26, 2013

    Report

    Report Number
    2024168-2013-04686
    Event Type
    Malfunction
    Date Received
    July 26, 2013
    Date of Event
    July 2, 2013
    Report Date
    July 3, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. 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. 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 THE PMA# ARE 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). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR ANALYSIS. THE REPORTED SEPARATION OF THE SHAFT WAS CONFIRMED. THE REPORTED DIFFICULTY REMOVING THE PROTECTIVE SHEATHS COULD NOT BE REPLICATED IN A TESTING ENVIRONMENT AS THE PROTECTIVE SHEATHS WERE NOT RETURNED. BASED ON THE VISUAL AND DIMENSIONAL 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. IT SHOULD BE NOTED THAT THE INSTRUCTIONS FOR USE (IFU) STATES: PRIOR TO REMOVAL OF THE PACKAGING MANDREL, CAREFULLY SLIDE THE YELLOW OUTER SHEATH TOWARDS THE DISTAL FLARE, OPENING THE LONGITUDINAL SPLIT ON THE INNER SHEATH. REMOVE BOTH SHEATH PIECES AND STYLET FROM THE DELIVERY SYSTEM. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING UNPACKING OF THE 2.5X28 MM DEVICE, AT THE MOMENT OF REMOVING THE PROTECTIVE SHEATH, RESISTANCE WAS EXPERIENCED AND THE DISTAL SHAFT SEPARATED. THERE WAS NO PATIENT INVOLVEMENT. THE PROCEDURE WAS CONCLUDED WITH SUCCESS BY USING ANOTHER DEVICE WITHOUT ANY CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO PATIENT EFFECTS HAVE BEEN REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    351201 ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 3040861

    Patients

    Seq Age Sex Outcome Treatment
    1