BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1895026 · Received November 5, 2010

    Report

    Report Number
    2024168-2010-02354
    Event Type
    Injury
    Date Received
    November 5, 2010
    Date of Event
    July 23, 2010
    Report Date
    October 11, 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
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THERE WAS NO REPORTED PRODUCT DEFICIENCY. ANGINA AND RESTENOSIS ARE KNOWN ADVERSE EVENTS AS LISTED IN THE XIENCE V INSTRUCTIONS FOR USE (IFU). ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PT EFFECTS AND THE RELATIONSHIP TO THE DEVICE, IF ANY, CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURE OR DESIGN.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA A TRAIL THAT ON (B)(6) 2008, THE PT UNDERWENT STENTING IN THE PREDILATED RIGHT POSTERIOR DESCENDING ARTERY WITH ONE XIENCE V STENT. ON (B)(6) 2010, THE PT REPORTED HAVING CHEST PAIN AT A MEDICAL OFFICE VISIT. ON (B)(6) 2010, THE CARDIAC CATHETERIZATION SHOWED SEVERE INSTENT RESTENOSIS IN THE INDEX TARGET LESION THAT WAS TREATED WITH A NON-ABBOTT DRUG ELUTING STENT AND A LESION IN THE FIRST DIAGONAL VESSEL THAT WAS TREATED WITH A NON-ABBOTT DRUG ELUTING STENT. ON (B)(6) 2010, AND (B)(6) 2010, THE PT WAS FOUND TO HAVE ELEVATED CARDIAC ENZYMES AND TROPONIN, BUT WAS ONLY DIAGNOSED AS CORONARY ARTERY DISEASE WITH POST PROCEDURE MILD ELEVATION IN TROPONIN. THE PATIENT'S CONDITION RESOLVED AND THE PT WAS DISCHARGED ON (B)(6) 2010. THERE WAS NO ADVERSE PT SEQUELA. THERE WAS NO ADDITIONAL INFO 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 7112741

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| R VESSEL CLOSURE: ANGIO-SEAL