BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2862997 · Received December 10, 2012

    Report

    Report Number
    2024168-2012-07754
    Event Type
    Malfunction
    Date Received
    December 10, 2012
    Date of Event
    November 13, 2012
    Report Date
    November 14, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. STENT IMPLANT DAMAGE AND DIFFICULT TO POSITION/GUIDING CATHETER RESISTANCE WERE CONFIRMED. BASED ON VISUAL, DIMENSIONAL, AND FUNCTIONAL 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.

    Additional Manufacturer Narrative · 1

    (B)(4). THE ADDITIONAL RX XIENCE PRIME 3.5 X 38 MM, RX XIENCE PRIME 4.0 X 33 MM, AND RX XIENCE V 4.0 X 12 MM MENTIONED ARE BEING FILED UNDER SEPARATE MANUFACTURER REPORT NUMBERS. THE PROCEDURE WAS COMPLETED WITH THE IMPLANTATION OF TWO XIENCE V STENTS AND TWO NON-ABBOTT STENTS. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS OR DELAY IN PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED. GUIDE CATHETER: MEDTRONIC EXTRA BACKUP, GUIDELINER AL.75 GUIDE MDT. 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

    REPORTEDLY THE PROCEDURE WAS TO TREAT THE FULL RIGHT CORONARY ARTERY (RCA) DESCRIBED AS TOTAL OCCLUSION WITH HEAVY CALCIFICATION AND HEAVY TORTUOSITY. A NON-ABBOTT ROTABLATOR WAS USED, BALLOONING WAS PERFORMED AND A NON-ABBOTT GUIDING CATHETER EXTENSION WAS USED. THE PHYSICIAN TRIED NUMEROUS STENTS. A 3.5 X 38 MM XIENCE PRIME STENT DELIVERY SYSTEM WAS ADVANCED INTO THE DISTAL RCA. THE XIENCE PRIME WAS UNABLE TO CROSS TO THE TARGET LESION, FORCE WAS APPLIED AND THE PROXIMAL SHAFT OF THE DEVICE SEPARATED INTO TWO SEGMENTS. THERE WERE NO DIFFICULTIES REMOVING THE SEPARATED SEGMENTS OF THE DEVICE FROM THE ANATOMY ALTHOUGH SOME RESISTANCE WAS NOTED DURING WITHDRAWAL. THE SAME THING HAPPENED WITH A 4.0 X 12 MM XIENCE V STENT DELIVERY SYSTEM; THE DEVICE WAS UNABLE TO CROSS TO THE TARGET LESION, FORCE WAS APPLIED AND THE PROXIMAL SHAFT SEPARATED INTO TWO SEGMENTS. THE SEPARATED SEGMENTS WERE REMOVED FROM THE ANATOMY WITHOUT DIFFICULTY ALTHOUGH SOME RESISTANCE WAS NOTED DURING WITHDRAWAL. DURING USE OF ANOTHER 3.5 X 38 MM XIENCE PRIME STENT DELIVERY SYSTEM AND A 4.0 X 33 MM XIENCE PRIME STENT DELIVERY SYSTEM, THE DEVICES WERE ADVANCED THROUGH A NON-ABBOTT GUIDING CATHETER; HOWEVER, RESISTANCE WAS FELT WITH THE GUIDING CATHETER AND THE DEVICES COULD NOT BE ADVANCED FURTHER. BOTH DEVICES WERE ABLE TO BE REMOVED FROM THE GUIDING CATHETER WITHOUT DIFFICULTY ALTHOUGH SOME RESISTANCE WAS NOTED DURING WITHDRAWAL; HOWEVER, UPON REMOVAL FROM THE ANATOMY, THE STENT OF EACH DEVICE WAS NOTED TO BE DAMAGED. IT IS UNKNOWN IF THE SAME GUIDE CATHETER WAS USED.

    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 2030641

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR CONCOMITANT MEDICAL DEVICES