BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1585550 · Received January 15, 2010

    Report

    Report Number
    2024168-2010-00080
    Event Type
    Malfunction
    Date Received
    January 15, 2010
    Date of Event
    December 16, 2009
    Report Date
    December 21, 2009
    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
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: PRODUCT PERFORMANCE ENGINEERING WAS UNABLE TO PERFORM AN EVAL AT THE TIME OF THIS REPORT. THE 2.5 X 18 MM XIENCE V (PART 1009539-18, LOT 9072141) HAS BEEN FILED UNDER MFR# 12024168-2010-00078. EVAL SUMMARY: QUALITY ASSURANCE ANALYSIS REVEALED THAT THE STENT DELIVERY SYSTEM (SDS) WAS RETURNED WITH BLOOD IN THE GUIDE WIRE LUMEN ON THE DISTAL TIP, STENT IMPLANT, BALLOON, DISTAL SHAFT AND HYPOTUBE. THERE WAS CONTRAST IN THE INFLATION LUMEN AND ON THE DISTAL SHAFT. THE STENT IMPLANT WAS DISLODGED FROM THE BALLOON AND WAS RETURNED LOOSE ON THE DISTAL SHAFT. THERE WAS NO DAMAGE NOTED TO THE STENT IMPLANT. THERE WERE CRIMP MARKS ON THE BALLOON IN BETWEEN THE MARKERS. THE BALLOON WAS TIGHTLY FOLDED. THERE WAS A WRINKLE IN THE DISTAL SHAFT 19.5 CM PROXIMAL TO THE PROXIMAL SEAL, FOR A LENGTH OF 3 MM. THERE WERE TWO KINKS IN THE DISTAL SHAFT 1 CM AND 14 CM DISTAL TO THE GUIDE WIRE EXIT NOTCH. THERE WERE MULTIPLE BENDS IN THE HYPOTUBE DISTAL TO THE STRAIN RELIEF TUBING. THERE WAS NO OTHER DAMAGE NOTED TO THE SDS. THE PROTECTIVE SHEATH WAS NOT RETURNED. THE ENTIRE LENGTH OF THE TIP WAS MEASURED AND MET MANUFACTURING CRITERIA. A SNAP GAUGE WAS USED TO MEASURE THE STENT IMPLANT OUTER DIAMETERS AND THESE DID NOT MEET MANUFACTURING CRITERIA, THEY WERE OVERSIZED. PRODUCT PERFORMANCE ENGINEERING WAS UNABLE TO PERFORM AN EVAL AT THE TIME OF THIS REPORT. RESULTS AND CONCLUSIONS WILL BE FORWARDED UPON COMPLETION.

    Description of Event or Problem · 1

    REPORTING STATUS: MALFUNCTION. REPORTING RATIONALE: STENT DISLODGEMENT HAS CAUSED OR CONTRIBUTED TO PT INJURY PREVIOUSLY. DEVICE ISSUE: STENT DISLODGEMENT. IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE MID TO DISTAL RCA. THERE WAS HEAVY TORTUOSITY, CALCIFICATION AND 95% STENOSIS. ANOTHER COMPANY'S BALLOON WAS USED FOR PRE-DILATATION, AT WHICH TIME THE VESSEL DISSECTED. THE 2.5 X 18 MM XIENCE V WAS ADVANCED, BUT WAS UNABLE TO CROSS AND WAS REMOVED. THE 3.5 X 12 MM XIENCE V WAS ADVANCED, BUT WOULD NOT CROSS AND AFTER IT WAS REMOVED, THE STENT WAS OBSERVED TO HAVE DISLODGED FROM THE BALLOON ONTO THE SHAFT. TWO STENTS FROM ANOTHER COMPANY WERE ABLE TO CROSS AND WERE DEPLOYED. UPON REVIEW OF THE CINE FILM, IT WAS NOTICED THAT THE 2.5 X 18 MM XIENCE STENT HAD DISLODGED IN THE MID RCA AND THE OTHER COMPANY'S STENTS HAD BEEN DEPLOYED ON TOP OF IT, COMPRESSING IT AGAINST THE VESSEL WALL. THERE WERE NO PT EFFECTS. NO ADDITIONAL EVENT OR PT INFO 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 NA 9010661

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR (PART 1009539-18, LOT 9072141)| STENT: 2.5 X 18 MM XIENCE V| DILATATION CATHETER: MAVERICK