BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3052992 · Received April 11, 2013

    Report

    Report Number
    2024168-2013-02196
    Event Type
    Injury
    Date Received
    April 11, 2013
    Date of Event
    March 19, 2013
    Report Date
    March 19, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. DIFFICULTY DEPLOYING THE STENT IMPLANT/WAIST AND DIFFICULTY/RESISTANCE REMOVING THE SDS POST-DEPLOYMENT COULD NOT BE REPLICATED IN A TESTING ENVIRONMENT AS THEY WERE BASED ON OPERATIONAL CIRCUMSTANCES. BASED ON VISUAL 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 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 DURING A PROCEDURE OF THE HEAVILY CALCIFIED, ECSTATIC, 95% STENOSED, DE NOVO MID CIRCUMFLEX, AFTER INITIAL PRE-DILATATION WITH A TREK RX BALLOON DILATATION CATHETER (BDC) A SECOND LESION WAS NOTED DISTAL TO THE INITIAL LESION. A 3.0 X 33 MM XIENCE PRIME STENT DELIVERY SYSTEM (SDS) WAS USED TO COVER BOTH LESIONS WITHOUT ISSUE. THE STENT IMPLANT WAS DEPLOYED USING 14 ATMOSPHERE (ATM) BUT WAISTING WAS SEEN AT THE POINT OF THE SECOND LESION. AN ATTEMPT TO REMOVE THE SDS BALLOON WAS MET WITH RESISTANCE AND THE SDS COULD NOT BE REMOVED. THE BALLOON WAS INFLATED AT 18 ATM BUT COULD NOT BE REMOVED AFTER DEFLATION. AN ADDITIONAL INFLATION TO 21 ATM WAS UNSUCCESSFUL AND THE BALLOON STILL COULD NOT BE REMOVED AFTER DEFLATION. THE GUIDE CATHETER WAS INSERTED INSIDE OF THE STENT AND THE SDS BALLOON WAS SUCCESSFULLY REMOVED. THE WAISTING WAS STILL NOTED AT THE SECOND LESION; POST-DILATATION WAS COMPLETED WITH A TREK NC AND A SMOOTH ANGIOGRAPHIC PROFILE WAS ACHIEVED. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    155620 XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 2080741

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention