BEUDAMED
    FDA Adverse Event Death Summary report: N

    XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3830983 · Received May 23, 2014

    Report

    Report Number
    2024168-2014-03321
    Event Type
    Death
    Date Received
    May 23, 2014
    Date of Event
    April 28, 2014
    Report Date
    April 29, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THERE WAS NO REPORTED DEVICE MALFUNCTION AND THE PRODUCT WAS NOT RETURNED. DEATH, THROMBOSIS AND ANGINA ARE LISTED IN THE XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEMS INSTRUCTIONS FOR USE (IFU) AS KNOWN PATIENT EFFECTS OF CORONARY STENTING PROCEDURES. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURING, DESIGN OR LABELING.

    Additional Manufacturer Narrative · 1

    (B)(4). THE STENT REMAINS IN THE ANATOMY. 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. BASED ON THE INFORMATION REVIEWED, THERE IS NO EVIDENCE TO INDICATE THE PRESENCE OF A PRODUCT DEFICIENCY. THE XIENCE V REFERENCED IS BEING FILED UNDER A SEPARATE MANUFACTURING REPORT NUMBER.

    Description of Event or Problem · 1

    SUBSEQUENT INFORMATION RECEIVED VIA PROCEDURE CINE AND REVIEWED BY AN ABBOTT SPECIALIST REVEALED THAT THERE ARE LESIONS PRESENT IN THE PROXIMAL TO MID DISTAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. A LONG STENT IS DEPLOYED IN THE PROXIMAL TO MID-DISTAL SEGMENT FOLLOWED BY BALLOON DILATATIONS. THE DISTAL END OF THE STENT APPEARS VISIBLY LARGER THAN THE ADJACENT VESSEL. A SECOND STENT IS IMPLANTED IN THE LAD OSTIUM WITH OVERLAP OF THE INITIAL STENT. THE LAD IS TOTALLY OCCLUDED. A MARKER (ASSUMED TO BE THAT OF THE THROMBUSTER) IS SEEN ADVANCING AND RETRACTING TO THE GUIDE CATHETER. BALLOON DILATATIONS ARE PERFORMED. FLOW DOES RETURN TO THE VESSEL BUT THERE ARE LARGE THROMBI STILL REMAINING IN THE VESSEL. IN CONCLUSION, THE IMAGES ARE CONSISTENT WITH THROMBOSIS IN THE IMPLANTED STENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2014 THE PATIENT WAS TREATED WITH A 3.0 X 38 MM XIENCE PRIME STENT AND A 3.5 X 23 MM XIENCE V STENT OVERLAPPING EACH OTHER IN THE DISTAL LEFT ANTERIOR DESCENDING (LAD) ARTERY WITH A GOOD RESULT. IT WAS NOTED THAT 7 DAYS POST-STENTING PROCEDURE IN THE AM OF (B)(6) 2014 THE PATIENT PRESENTED WITH CHEST PAIN AND USING A FEMORAL ARTERY ACCESS APPROACH, THE ANGIOGRAPHY SHOWED THROMBOSIS IN THE UNSPECIFIED DEPLOYED STENTS. THE PATIENT WAS TREATED WITH THROMBUSTER TO REMOVE THE THROMBUS AND WAS DILATATED WITH A 3.0 X 12 MM NC TREK, AND WAS HOSPITALIZED AND KEPT FOR OBSERVATION IN ICU; HOWEVER, THE PATIENT DIED LATER IN THE EVENING. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    307822 XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 3112041

    Patients

    Seq Age Sex Outcome Treatment
    1 Death