BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2801862 · Received October 23, 2012

    Report

    Report Number
    2024168-2012-06688
    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. (B)(4): NO PRE-DILATATION. THE DEVICE IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: 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 BEND/KINK 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 INSTRUCTIONS FOR USE (IFU) INSTRUCTS THE PHYSICIAN TO PRE-DILATE THE LESION WITH A PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETER. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCEDURE, WITHOUT PRE-DILATING THE LESION, A 2.75 X 38 RX XIENCE PRIME STENT DELIVERY SYSTEM (SDS) WAS ADVANCED ONTO A BALANCE MIDDLEWEIGHT UNIVERSAL II GUIDE WIRE AND TOWARD A MILDLY CALCIFIED, 90% STENOSED, DE NOVO LESION IN THE MODERATELY TORTUOUS MID LEFT ANTERIOR DESCENDING CORONARY ARTERY, BUT WAS UNABLE TO CROSS THE LESION. THOUGH NO FORCE WAS APPLIED, A FRACTURED, BUT STILL INTACT, PROXIMAL SHAFT RESULTED. THE XIENCE PRIME WAS WITHDRAWN FROM THE ANATOMY WITHOUT RESISTANCE AND PLAIN OLD BALLOON ANGIOPLASTY OF THE LESION WAS PERFORMED USING A NON-ABBOTT BALLOON DILATATION CATHETER. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO OCCURRENCE OF A CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE INITIAL MEDWATCH REPORT, THE ABBOTT RETURNED GOODS LAB RECEIVED THE DEVICE WITH ITS PROXIMAL SHAFT KINKED; HOWEVER, NO FRACTURE WAS NOTED. ADDITIONAL INFORMATION RECEIVED FROM THE SITE INDICATED THAT THE KINK HAD BEEN PERCEIVED BY THE PHYSICIAN AS A FRACTURE. 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 2031341

    Patients

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