BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2861530 · Received December 7, 2012

    Report

    Report Number
    2024168-2012-07719
    Event Type
    Injury
    Date Received
    December 7, 2012
    Date of Event
    November 14, 2012
    Report Date
    November 14, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. THE REPORTED SHAFT DETACHMENT WAS CONFIRMED. THE REPORTED DIFFICULTY TO REMOVE AND DETACHMENT COULD NOT BE REPLICATED IN A TESTING ENVIRONMENT AS IT WAS BASED ON OPERATIONAL CIRCUMSTANCES. BASED ON ANALYSIS OF THE RETURNED DEVICE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES FOR THIS LOT. 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 EVIDENCE TO INDICATE THE PRESENCE OF A PRODUCT DEFICIENCY.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION REPORTED THAT THE STENT WAS DEPLOYED SUCCESSFULLY AT NOMINAL PRESSURE, FOR 17 SECONDS. THE STENT WAS WELL APPOSED TO THE VESSEL WALL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE LEFT ANTERIOR DESCENDING ARTERY WITH MILD TORTUOSITY AND NO CALCIFICATION. PRE-DILATATION WAS PERFORMED AND THE 3.5 X 38 MM XIENCE PRIME STENT DELIVERY SYSTEM (SDS) WAS ADVANCED WITHOUT ISSUE. THE STENT WAS DEPLOYED SUCCESSFULLY AT NOMINAL PRESSURE. THE SDS BALLOON WAS CONFIRMED TO BE FULLY DEFLATED, AND AN ATTEMPT WAS MADE TO REMOVE THE DEVICE; HOWEVER, RESISTANCE WAS NOTED WITH THE DEPLOYED STENT, AND THE MID SHAFT SEPARATED. A SNARE DEVICE WAS USED TO REMOVE THE SEPARATED PORTION SUCCESSFULLY. THERE WAS NO DAMAGE NOTED TO THE IMPLANTED STENT. THE PATIENT EXPERIENCED A SMALL VENTRICULAR TACHYCARDIA THAT WAS RESOLVED WITHOUT MEDICATION. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A GOOD PATIENT OUTCOME. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 2061241

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention