BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1847161 · Received September 24, 2010

    Report

    Report Number
    2024168-2010-01993
    Event Type
    Injury
    Date Received
    September 24, 2010
    Date of Event
    July 21, 2010
    Report Date
    August 31, 2010
    Manufacturer
    ABBOTT VASCULAR-CARDIAC THERAPIES
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE STENT REMAINS IN THE PATIENT. THE CUSTOMER REPORTED THE STENT DELIVERY SYSTEM WAS DISCARDED. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. THE OTHER TWO XIENCE V DEVICES MENTIONED ARE BEING REPORTED UNDER SEPARATE MEDWATCH REPORT NUMBERS.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA TRIAL THAT APPROXIMATELY 20 MONTHS POST STENT IMPLANTATION OF 2 XIENCE V STENTS (2.5X28MM) IN THE DISTAL CIRCUMFLEX (CX) ARTERY (PLACED ON (B)(6) 2008), AND 11 MONTHS AFTER STENT IMPLANTATION OF ONE XIENCE V STENT (2.75X28MM) IN THE MID CX (PLACED ON (B)(6) 2009), THE PATIENT EXPERIENCED MID STERNAL CHEST PAIN WHICH WAS TREATED WITH NITROGLYCERIN RESULTING IN SYNCOPE. THE PATIENT WAS HOSPITALIZED FOR THE SYNCOPE AND ELEVATED CARDIAC ENZYMES. ON (B)(6) 2010, AN ANGIOGRAM SHOWED 99% IN STENT RESTENOSIS (ISR) IN THE 2.75X28MM XIENCE V STENT IMPLANTED IN THE MID CX TO THE EDGE OF THE MOST PROXIMAL XIENCE V STENT IN THE DISTAL CX. TREATMENT INCLUDED INTEGRELIN, ADDITIONAL PLAVIX AND CUTTING BALLOON ANGIOPLASTY. POST PROCEDURE STENOSIS WAS 10%. ADDITIONALLY, FOCAL ISR WAS SEEN NEAR THE DISTAL END OF THE XIENCE V STENT IN THE DISTAL CX. ON (B)(6) 2010, THE PATIENT EXPERIENCED RECURRENT ANGINA. CARDIAC ENZYMES WERE NEGATIVE. ON (B)(6) 2010, 80% ISR WAS NOTED WITHIN THE DISTAL EDGE OF THE XIENCE V STENT IN THE DISTAL CX TO THE LEFT POSTERIOR DESCENDING ARTERY (LPDA). A XIENCE V STENT WAS PLACED AS TREATMENT, RESOLVING THE EVENT. POST-PROCEDURE STENOSIS WAS 0%. THERE WAS NO ADVERSE PATIENT SEQUELA REPORTED. ALTHOUGH REQUESTED, THERE WAS NO ADDITIONAL INFORMATION 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 8071761

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| R OTHER: ASPIRIN| STENT: TAXUS STENT| 2.5 X 28 MM XIENCE V (1009539-28, 8071761)| CLOPIDOGREL| 2.75 X 28 MM XIENCE V (1009540-28, 9052761)