BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1831828 · Received September 8, 2010

    Report

    Report Number
    2024168-2010-01884
    Event Type
    Malfunction
    Date Received
    September 8, 2010
    Date of Event
    August 18, 2010
    Report Date
    August 18, 2010
    Manufacturer
    ABBOTT VASCULAR-CARDIAC THERAPIES CLONMEL
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. THE XIENCE V 3.0 X 18 MM (PART#1009529-18/LOT#0011342/(B)(4)) IS BEING FILED UNDER A SEPARATE MANUFACTURER NUMBER.

    Additional Manufacturer Narrative · 1

    INTERNAL FILE NUMBER - (B)(4). IT WAS INITIALLY REPORTED THAT THE DEVICE WOULD BE RETURNED FOR ANALYSIS. SUBSEQUENT INFORMATION REVEALED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION. EVALUATION SUMMARY: THE INABILITY TO CROSS A LESION CAN BE AFFECTED BY NUMEROUS FACTORS INCLUDING, BUT NOT LIMITED TO, PATIENT ANATOMICAL MORPHOLOGY, PATIENT DISEASE STATE, PRE-DILATATION STRATEGY, DEVICE PLACEMENT TECHNIQUE, AND ACCESSORY DEVICE SUPPORT. THE PATIENT ANATOMY WAS MILDLY TORTUOUS AND MODERATELY CALCIFIED, WHICH LIKELY CONTRIBUTED TO THE FAILURE TO ADVANCE. KINKS OR BENDS IN THE SHAFT CAN LEAD TO WEAKENING OF THE STENT DELIVERY SYSTEM (SDS) MATERIAL SUCH THAT SUBSEQUENT APPLICATION OF FORCE OR FURTHER HANDLING CAN CAUSE A SEPARATION. TO HELP ENSURE THIS TYPE OF DAMAGE IS NOT THE RESULT OF A MANUFACTURING DEFICIENCY, ALL PRODUCTS ARE 100% VISUALLY INSPECTED FOR KINKS. ADDITIONALLY, A SAMPLING OF PRODUCT IS DESTRUCTIVELY TESTED TO VERIFY LUMEN INTEGRITY. IT IS LIKELY AN INTERACTION WITH THE LESION/ANATOMY DURING THE ATTEMPT TO CROSS THE CALCIFIED LESION MAY HAVE RESULTED IN A KINK IN THE HYPOTUBE. FURTHER HANDLING COULD HAVE CONTRIBUTED TO THE SHAFT ULTIMATELY SEPARATING. IN THIS CASE, THE REPORTED FAILURE TO ADVANCE AND NOTED HYPOTUBE SEPARATION APPEAR TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE. A REVIEW OF THE PRODUCT MANUFACTURING RECORDS DID NOT REVEAL ANY NON-CONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT THAT COULD HAVE CONTRIBUTED TO THIS REPORT AND ALL LOT RELEASE TESTING MET MANUFACTURING CRITERIA. THE PROFILE DIMENSIONS ON ALL STENT DELIVERY SYSTEMS ARE CONFIRMED BY VISUAL AND DIMENSIONAL CHECKS ON THE MANUFACTURING LINE BEFORE RELEASE. ALL STENT DELIVERY SYSTEMS ARE 100% VISUALLY INSPECTED FOR KINKS DURING THE MANUFACTURING PROCESS. ADDITIONALLY, A SAMPLING OF UNITS IS DESTRUCTIVELY TESTED TO VERIFY LUMEN INTEGRITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD UNDERGONE ANGIOPLASTY 8 MONTHS PREVIOUS IN THE RIGHT CORONARY ARTERY (RCA) AND SUFFERED A LATE STENT THROMBOSIS IN THE SAME ARTERY. THE LESION WAS PRE-DILATED WITH A NON-ABBOTT BALLOON CATHETER. THE PHYSICIAN TRIED TO CROSS THE LESION WITH THE XIENCE V 3.0 X 18 MM BUT THE SHAFT BROKE AND HE COULD NOT IMPLANT THE STENT. THE PHYSICIAN THEN TRIED TO CROSS THE LESION WITH A XIENCE V 3.0 X 23 MM BUT THE SHAFT BROKE AGAIN AND HE COULD NOT IMPLANT THE STENT. FINALLY, THE PHYSICIAN TRIED TO CROSS THE LESION WITH ANOTHER XIENCE V 3.0 X 23 MM AND WAS ABLE TO SUCCESSFULLY IMPLANT THE STENT. POST DILATATION WAS PERFORMED WITH A NON-ABBOTT BALLOON CATHETER. NO PATIENT EFFECTS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM NIQ ABBOTT VASCULAR-CARDIAC THERAPIES CLONMEL NA 0020941

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male DILATATION CATHETER: NC SPRINTER 3.5X9| GUIDE CATH: 7F JR 3.5| GUIDE WIRE: MBW| INFLATION: MEDTRONIC| PART#1009529-18/LOT#0011342/SERIAL#(B)(6)| SHEATH: CORDIS| STENT: XIENCE V 3.0 X 18 MM| PART#1009529-18/LOT#0011342/SERIAL#47062| STENT: XIENCE V 3.0 X 18 MM| GUIDE CATH: 7F JR 3.5| INFLATION: MEDTRONIC| SHEATH: CORDIS| DILATATION CATHETER: NC SPRINTER 3.5X9| GUIDE WIRE: MBW