BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2801573 · Received October 23, 2012

    Report

    Report Number
    2024168-2012-06680
    Event Type
    Malfunction
    Date Received
    October 23, 2012
    Date of Event
    September 28, 2012
    Report Date
    September 28, 2012
    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). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW UP WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. SHAFT SEPARATION/DETACHMENT 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. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE OF THE MODERATELY TORTUOUS, MILDLY CALCIFIED, 90% STENOSED DE NOVO MID LEFT ANTERIOR DESCENDING ARTERY, THE 2.5 X 38 MM XIENCE PRIME STENT DELIVERY SYSTEM (SDS) WAS ADVANCED, BUT BECAME STUCK AT THE LESION AND COULD NOT CROSS; THE DEVICE WAS REMOVED FROM THE ANATOMY WITHOUT ISSUE, HOWEVER, THE PROXIMAL SHAFT WAS NOTED TO BE BROKEN/DAMAGED. THE PROCEDURE WAS COMPLETED WITH PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) WITH A NON-ABBOTT BALLOON DILATATION CATHETER. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    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 2030841

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR GUIDE WIRE: BALANCE MIDDLEWEIGHT UNIVERSAL II