BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2851874 · Received November 29, 2012

    Report

    Report Number
    2024168-2012-07574
    Event Type
    Malfunction
    Date Received
    November 29, 2012
    Date of Event
    October 9, 2012
    Report Date
    October 9, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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. EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. FAILURE TO CROSS THE LESION/PHYSICAL RESISTANCE IN THE LESION THE LESION COULD NOT BE REPLICATED IN A TESTING ENVIRONMENT AS IT WAS BASED ON OPERATIONAL CIRCUMSTANCES. SHAFT KINK WAS CONFIRMED. ADDITIONALLY, SHAFT SEPARATION WAS NOTED. 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. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE OF THE CIRCUMFLEX ARTERY, THE XIENCE PRIME STENT DELIVERY SYSTEM (SDS) MET RESISTANCE WHILE BEING ADVANCED AND THE SHAFT BECAME KINKED DURING USE BUT REMAINED IN ONE PIECE. THE DEVICE WAS REMOVED WITHOUT REPORTED ISSUE. A SECOND STENT SYSTEM WAS USED SUCCESSFULLY IN THE PROCEDURE. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED. RETURN DEVICE ANALYSIS REVEALED THE PROXIMAL SHAFT WAS SEPARATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 1120541

    Patients

    Seq Age Sex Outcome Treatment
    1