BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2827583 · Received November 9, 2012

    Report

    Report Number
    2024168-2012-07098
    Event Type
    Malfunction
    Date Received
    November 9, 2012
    Date of Event
    October 1, 2012
    Report Date
    October 18, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: RE-INSERTION. THE DEVICE WAS RETURNED FOR EVALUATION. FAILURE TO ADVANCE/CROSS THE LESION COULD NOT BE REPLICATED IN A TESTING ENVIRONMENT AS IT WAS BASED ON OPERATIONAL CIRCUMSTANCES. SHAFT SEPARATION WAS CONFIRMED. 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. IT SHOULD BE NOTED THAT THE XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM (IFU) STATES: AN UNEXPANDED STENT SHOULD NOT BE REINTRODUCED INTO THE ARTERY ONCE IT HAS BEEN PULLED BACK INTO THE GUIDING CATHETER. ADDITIONALLY, THE IFU ALSO STATES: SHOULD ANY RESISTANCE BE FELT AT ANY TIME DURING EITHER LESION ACCESS OR REMOVAL OF THE DELIVERY SYSTEM POST-STENT IMPLANTATION, THE ENTIRE SYSTEM SHOULD BE REMOVED AS A SINGLE UNIT. FAILURE TO FOLLOW THESE STEPS AND/OR APPLYING EXCESSIVE FORCE TO THE DELIVERY SYSTEM CAN POTENTIALLY RESULT IN LOSS OR DAMAGE TO THE STENT AND/OR DELIVERY SYSTEM COMPONENTS. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION 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. (B)(4). THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TARGET LESION WAS LOCATED IN THE DISTAL RIGHT CORONARY ARTERY (RCA), WITH HEAVY TORTUOSITY AND NO CALCIFICATION. THERE WAS AN ANGULATION IN THE MID PART OF THE VESSEL AND THE 3.0 X 23 MM XIENCE PRIME STENT DID NOT CROSS THIS REGION. THERE WERE MANY ATTEMPTS, INCLUDING PRE-DILATATION, BUT WITH NO SUCCESS. THE PHYSICIAN APPLIED FORCE TO CROSS THE LESION AND THE SHAFT OF THE DELIVERY SYSTEM SEPARATED AT A POINT OUTSIDE THE ANATOMY. AFTER THIS, A 3.0 X 24 MM NON-ABBOTT STENT WAS IMPLANTED WITH NO DIFFICULTIES. NO ADVERSE PATIENT EFFECTS WERE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    SUBSEQUENT TO FILING THE INITIAL MEDWATCH REPORT, INFORMATION WAS RECEIVED CONFIRMING THAT THE DEVICE WAS REMOVED AND RE-INSERTED INTO THE PATIENT FOR ADDITIONAL PRE-DILATATIONS.

    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 1120141

    Patients

    Seq Age Sex Outcome Treatment
    1