BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3250324 · Received July 26, 2013

    Report

    Report Number
    2024168-2013-04695
    Event Type
    Injury
    Date Received
    July 26, 2013
    Date of Event
    July 1, 2013
    Report Date
    July 3, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    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. IT SHOULD BE NOTED THAT THE XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM INSTRUCTIONS FOR USE (IFU), STATES: DO NOT EXCEED RBP AS INDICATED ON PRODUCT LABEL. BALLOON PRESSURES SHOULD BE MONITORED DURING INFLATION. USE OF PRESSURES HIGHER THAN SPECIFIED ON PRODUCT LABEL MAY RESULT IN A RUPTURED BALLOON WITH POSSIBLE INTIMAL DAMAGE AND DISSECTION. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS AND THE RELATIONSHIP TO THE DEVICE IF ANY CANNOT BE DETERMINED, PERFORATION AND SURGICAL PROCEDURE ARE LISTED AS KNOWN ADVERSE EVENTS ASSOCIATED WITH THE REPORTED IFU DEVIATION OF INFLATING ABOVE RBP. THE ADDITIONAL XIENCE PRIME REFERENCED IN B5 IS BEING FILED UNDER A SEPARATE MEDWATCH REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 99% STENOSED LESION IN THE PROXIMAL TO MID LEFT ANTERIOR DESCENDING ARTERY WITH MODERATE TORTUOSITY AND HEAVY CALCIFICATION. PRE-DILATATION WAS PERFORMED AND THE 2.5 X 38 MM XIENCE PRIME STENT DELIVERY SYSTEM (SDS) WAS ADVANCED. IT WAS NOTED THAT RESISTANCE WAS FELT WITH THE CALCIFIED VESSEL DURING ADVANCEMENT, BUT THE STENT WAS DEPLOYED SUCCESSFULLY AT 22 ATMOSPHERES (ATM). AFTER DEPLOYMENT, A DISTAL EDGE DISSECTION WAS OBSERVED. THE 3.0 X 28 MM XIENCE PRIME SDS WAS THEN ADVANCED AND RESISTANCE WAS FELT AGAIN WITH THE CALCIFICATION. THE STENT WAS DEPLOYED AT 22 ATM TO TREAT THE DISSECTION; HOWEVER, DUE TO THE HEAVY CALCIFICATION, A PERFORATION OCCURRED. THE PATIENT WAS SENT TO SURGERY, AND THE PERFORATION WAS TREATED SUCCESSFULLY. THE PATIENT IS IN GOOD CONDITION. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350634 XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 3020541

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| R