BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1902292 · Received November 11, 2010

    Report

    Report Number
    2024168-2010-02426
    Event Type
    Injury
    Date Received
    November 11, 2010
    Date of Event
    May 25, 2010
    Report Date
    October 18, 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
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) INDICATION FOR USE (RESTENOSIS). (B)(4). EVAL SUMMARY: IN THIS CASE, THERE WAS NO REPORTED PRODUCT DEFICIENCY. THE REPORTED PT EFFECTS OF ISCHEMIA, THROMBOSIS, EKG/ECG CHANGES, AND HOSPITALIZATION ARE KNOWN ADVERSE EVENTS LISTED IN THE XIENCE V INSTRUCTIONS FOR USE. 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, DESIGN OR LABELING. IT WAS REPORTED THE XIENCE V WAS USED TO TREAT IN-STENT RESTENOSIS OF A PREVIOUSLY IMPLANTED STENT. IT SHOULD BE NOTED THE IFU STATES: SAFETY AND EFFECTIVENESS OF THE STENT HAVE NOT BEEN ESTABLISHED FOR SUBJECT POPULATIONS WITH IN-STENT RESTENOSIS. IN THIS CASE, IT IS UNK HOW THE USE OF THE XIENCE V STENT TO TREAT THE IN-STENT RESTENOSIS MAY HAVE CONTRIBUTED TO THE REPORTED PT EFFECTS.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2010, THERE WAS IN-STENT RESTENOSIS OBSERVED IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (PLAD). ON (B)(6) 2010, PERCUTANEOUS CORONARY INTERVENTION (PCI) WAS PERFORMED TO TREAT THE RESTENOSIS CONFIRMED ON APRIL 9TH. A 3.5 X 23 MM UNK RX XIENCE STENT AND A NON ABBOTT STENT WERE BOTH DEPLOYED IN THE PLAD. ON (B)(4) 2010, THROMBOSIS WAS OBSERVED IN THE PLAD. THE PT HAD ISCHEMIC SYMPTOMS, ANOMALY WAS NOTED ON ECG. BALLOON ANGIOPLASTY WAS PERFORMED TO TREAT THE THROMBOSIS. THOUGH REQUESTED, NO ADDITIONAL EVENT OR PT INFO WAS PROVIDED.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE INITIAL MEDWATCH REPORT, THE ADDITIONAL INFORMATION WAS RECEIVED: IT WAS REPORTED THAT ON (B)(6) 2010, THERE WAS RESTENOSIS OBSERVED IN THE LEFT ANTERIOR DESCENDING (LAD/#6). ON (B)(6) 2010, PERCUTANEOUS CORONARY INTERVENTION (PCI) WAS PERFORMED TO TREAT THE RESTENOSIS OF A NON ABBOTT STENT, WHICH WAS CONFIRMED ON (B)(6). THE VESSEL WAS CONCENTRIC, MILDLY TORTUOUS AND MILDLY CALCIFIED. AN RX XIENCE STENT AND A NON ABBOTT STENT WERE BOTH DEPLOYED IN THE LAD. THE XIENCE V STENT WAS IMPLANTED AT THE LESION AT 12 ATM FOR 30 SECONDS AND WAS POST DILATED. INTRAVASCULAR ULTRA SOUND (IVUS) WAS PERFORMED AFTER THE XIENCE V STENT WAS DEPLOYED AND THERE WERE NO ISSUES NOTED AT THAT TIME. ON (B)(6) 2010, THROMBOSIS WAS OBSERVED IN THE LAD. THE PATIENT HAD ISCHEMIC SYMPTOMS, ANOMALY WAS NOTED ON ECG: UAP. PLAIN OLD BALLOON ANGIOPLASTY (POBA) WAS PERFORMED TO TREAT THE THROMBOSIS. THOUGH REQUESTED, NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ ABBOTT VASCULAR - CARDIAC THERAPIES NA 9110261

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| R TAXUS LIBERTE: 3.0 X 20| TAXUS LIBERTE: 3.5 X 20