BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1831813 · Received September 8, 2010

    Report

    Report Number
    2024168-2010-01883
    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

    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 23 MM (PART# 1009529-23/LOT#0020941/(B)(4)) MENTIONED IS BEING FILED UNDER A SEPARATE MANUFACTURER NUMBER.

    Description of Event or Problem · 1

    REPORTEDLY, THE PATIENT HAD UNDERGONE ANGIOPLASTY 8 MONTHS PREVIOUS IN THE RIGHT CORONARY ARTERY (RCA) AND SUFFERED 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 0011342

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR GUIDE CATH: 7F JR 3.5| SHEATH: CORDIS| DILATATION CATHETER: NC SPRINTER 3.5 X 9| PART# 1009529-23/LOT#0020941/(B)(4)| STENT: XIENCE V 3.0 X 23 MM| INFLATION: MEDTRONIC| GUIDE WIRE: BMW