BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3130500 · Received May 24, 2013

    Report

    Report Number
    2024168-2013-03273
    Event Type
    Malfunction
    Date Received
    May 24, 2013
    Date of Event
    April 19, 2013
    Report Date
    April 29, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION. THE TWO XIENCE PRIMES REFERENCED ARE BEING FILED UNDER SEPARATE MANUFACTURING REPORT NUMBERS.

    Additional Manufacturer Narrative · 1

    (B)(4) - NO PRE-DILATATION. EVALUATION SUMMARY: THE COMPLAINT DEVICE WAS RETURNED. FAILURE TO ADVANCE/CROSS THE LESION AND DIFFICULT TO REMOVE FROM THE ANATOMY COULD NOT BE REPLICATED IN A TESTING ENVIRONMENT AS IT WAS BASED ON OPERATIONAL CIRCUMSTANCES. SHAFT SEPARATION WAS CONFIRMED VIA RETURNED DEVICE ANALYSIS. BASED ON THE 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. A 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. IT SHOULD BE NOTED THAT THE XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM INSTRUCTION FOR USE INSTRUCTS THE PHYSICIAN TO PRE-DILATE THE LESION WITH A PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE HEAVILY CALCIFIED, MODERATELY TORTUOUS, MID LEFT ANTERIOR DESCENDING ARTERY. ATTEMPTS TO CROSS WERE MADE WITH ONE 2.75X38 MM XIENCE PRIME STENT DELIVERY SYSTEM (SDS) AND THREE 2.5X38 MM XIENCE PRIME SDS, ALL OF WHICH FAILED TO CROSS. RESISTANCE WAS ALSO FELT DURING RETRACTION OF THE THREE 2.5X38 MM XIENCE PRIME SDS FROM THE ANATOMY WHICH RESULTED IN ALL THREE DISTAL SHAFTS SEPARATING OUTSIDE THE PATIENT. AN UNKNOWN NON-ABBOTT SDS WAS ABLE TO CROSS THE LESION SUCCESSFULLY. NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE DUE TO THE FAILURE OF THE DEVICES TO CROSS. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION: THE LESION WAS NOT PRE-DILATED PRIOR TO THE ATTEMPTS TO STENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    232672 XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 2121341

    Patients

    Seq Age Sex Outcome Treatment
    1