BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1920413 · Received December 10, 2010

    Report

    Report Number
    2024168-2010-02678
    Event Type
    Malfunction
    Date Received
    December 10, 2010
    Date of Event
    November 17, 2010
    Report Date
    November 17, 2010
    Manufacturer
    AV-CLONMEL
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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. BALLOON MATERIAL RUPTURES CAN BE AFFECTED BY NUMEROUS FACTORS INCLUDING, BUT NOT LIMITED TO, BALLOON DAMAGE DURING PROCESSING OF THE BALLOON MATERIAL, MATERIALS, INFLATION TECHNIQUE, INTERACTIONS WITH OTHER DEVICES, A PREVIOUSLY IMPLANTED STENT, PATIENT ANATOMY, LESION CALCIFICATION AND TORTUOSITY, OR INSUFFICIENT PREPARATION PRIOR TO USE. THERE WAS NO REPORTED OF DIFFICULTY DURING PREPARATION OF THE DEVICE, WHICH WOULD SUGGEST THAT A PRODUCT DEFICIENCY DID NOT CONTRIBUTE TO THE REPORTED BALLOON RUPTURE. IT IS POSSIBLE THE REPORTED MODERATELY TORTUOUS AND MILDLY CALCIFIED LESION CONTRIBUTED TO THE REPORTED BALLOON RUPTURE, HOWEVER, A CONCLUSIVE CAUSE CANNOT BE DETERMINED. A REVIEW OF THE FINISHED DEVICE LOT HISTORY RECORDS DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT WHICH COULD HAVE CONTRIBUTED TO THIS COMPLAINT. ALTHOUGH THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY, WITHOUT RETURN OF THE DEVICE, A DEFINITIVE CAUSE COULD NOT BE DETERMINED. TO ENSURE THIS TYPE OF DAMAGE IS NOT A RESULT OF A POTENTIAL MANUFACTURING DEFICIENCY, ALL DILATATION CATHETERS ARE 100% VISUALLY INSPECTED AND LEAK TESTED DURING THE MANUFACTURING PROCESS. A SAMPLING OF UNITS IS ALSO DESTRUCTIVELY TESTED TO VERIFY RBP AND BALLOON INTEGRITY. THE ON-LINE TEST DATA FOR THIS LOT WAS REVIEWED AND SHOWS ALL UNITS PASSED THE MANUFACTURING CRITERIA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRE-DILATATION WAS PERFORMED AND THE XIENCE STENT WAS POSITIONED. DURING THE FIRST INFLATION, THE BALLOON RUPTURED AT 12 ATMOSPHERES. A NON-ABBOTT BALLOON WAS THEREFORE USED FOR POST-DILATATION AND COMPLETION OF THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED AND NO PATIENT EFFECTS WERE NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-CLONMEL 0061441

    Patients

    Seq Age Sex Outcome Treatment
    1 DILATATION CATHETER: 2.5 X 15 POTENZA