BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1840671 · Received September 17, 2010

    Report

    Report Number
    2024168-2010-01938
    Event Type
    Malfunction
    Date Received
    September 17, 2010
    Date of Event
    August 24, 2010
    Report Date
    August 26, 2010
    Manufacturer
    ABBOTT VASCULAR - CARDIAC THERAPIES
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: BALLOON MATERIAL RUPTURES CAN BE AFFECTED BY NUMEROUS FACTORS INCLUDING, BUT NOT LIMITED TO, BALLOON DAMAGE DURING MANUFACTURING, MATERIALS, HANDLING, LESION CALCIFICATION AND TORTUOSITY, AN INTERACTION WITH A PREVIOUSLY IMPLANTED STENT, INSUFFICIENT PREPARATION PRIOR TO USE OR FROM INTERACTIONS WITH OTHER DEVICES. SINCE THERE WAS NO REPORT OF ANY LEAKS NOTED DURING PREPARATION FOR USE, THIS MAY INDICATE THAT THE BALLOON WAS NOT DAMAGED PRIOR TO THE PROCEDURE. ADDITIONALLY, THE LESION WAS REPORTED AS MILDLY CALCIFIED AND 90% STENOSED, WHICH MAY HAVE CONTRIBUTED TO THE REPORTED RUPTURE. IF THE BALLOON EXPERIENCES MECHANICAL DAMAGE AT SOME POINT DURING THE PROCEDURE, THIS CAN CAUSE THE MATERIAL TO WEAKEN AND RUPTURE DURING AN ATTEMPT TO INFLATE THE CATHETER. THE BALLOON MATERIAL MAY HAVE BEEN DAMAGED (SCRATCHED) DURING INTERACTIONS WITH OTHER DEVICES AND/OR THE CALCIFIED LESION SUCH THAT UPON INFLATION ATTEMPT, THE BALLOON RUPTURED. ULTIMATELY, RETURN OF THE STENT DELIVERY SYSTEM (SDS) MAY HAVE ASSISTED THE EVALUATION IN DETERMINING A CAUSE FOR THE REPORTED DIFFICULTY. A REVIEW OF THE FINISHED PRODUCT LOT HISTORY RECORD DID NOT REVEAL ANY NON-CONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT AND ALL LOT RELEASE TESTING MET MANUFACTURING CRITERIA. IN THIS CASE, WITHOUT THE PRODUCT TO EXAMINE, A DEFINITIVE CAUSE FOR THE REPORTED BALLOON RUPTURE CANNOT BE DETERMINED, HOWEVER, THERE DOES NOT APPEAR TO BE ANY INDICATION OF A PRODUCT QUALITY DEFICIENCY. ALL STENT DELIVERY SYSTEMS ARE 100% VISUALLY INSPECTED AND A LEAK TESTED DURING THE MANUFACTURING PROCESS. ADDITIONALLY, A SAMPLING OF UNITS IS DESTRUCTIVELY TESTED TO VERIFY RBP AND BALLOON INTEGRITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRE-DILATATION OF THE LESION WAS PERFORMED USING A NON-ABBOTT BALLOON CATHETER. THEN, THE XIENCE V WAS PRESSURIZED BUT THE BALLOON RUPTURED AT 8 ATMOSPHERES DURING THE FIRST INFLATION AND THE STENT WAS NOT DEPLOYED. THE LESION WAS STENTED AND POST-DILATED WITH NON-ABBOTT PRODUCTS. NO PATENT EFFECTS WERE REPORTED. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM NIQ ABBOTT VASCULAR - CARDIAC THERAPIES NA 9111241

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK GUIDE WIRE: WHISPER MS| CYPHER| SION| DILATATION CATHETER: TAZUNA 2.5-10| IBP22 3.5-10| GUIDE CATH: HEARTRAIL II JL3.5| STENT: XIENCE V