BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1599252 · Received February 5, 2010

    Report

    Report Number
    2024168-2010-00179
    Event Type
    Injury
    Date Received
    February 5, 2010
    Date of Event
    January 8, 2010
    Report Date
    January 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
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). RESULTS AND CONCLUSIONS SUMMATION - IN THIS CASE, THERE WAS NO REPORTED PRODUCT DEFICIENCY. ANGINA AND RESTENOSIS ARE KNOWN ADVERSE EVENTS AS LISTED IN THE XIENCE V INSTRUCTIONS FOR USE. A REVIEW OF THE DEVICE LOT HISTORY RECORD DID NOT REVEAL ANY NON-CONFORMITIES WHICH COULD HAVE CONTRIBUTED TO THIS COMPLAINT. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT 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. THE SECOND XIENCE V STENT (PART 1009541-15, LOT 8102361), INDICATED IS BEING FILED UNDER THE SAME MFR#.

    Description of Event or Problem · 1

    REPORTING STATUS: SERIOUS INJURY - MEDICAL INTERVENTION. REPORTING RATIONALE: RESTENOSIS REQUIRING MEDICAL INTERVENTION. DEVICE ISSUE: NO DEVICE MALFUNCTION HAS BEEN REPORTED. IT WAS REPORTED THAT ON (B) (6) 2009, PRE-DILATATION WAS PERFORMED PRIOR TO STENTING OF THE OBTUSE MARGINAL (OM) WITH A XIENCE V STENT, AND THE PROXIMAL CIRCUMFLEX (CX) ARTERY WITH ANOTHER XIENCE V STENT. ON (B) (6) 2010, THE PATIENT AWAKENED WITH MID-STERNAL CHEST HEAVINESS, TOOK 2-3 NITROGLYCERIN, AND THE SYMPTOMS RETURNED AN HOUR LATER ASSOCIATED WITH SHORTNESS OF BREATH. THE PATIENT REPEATED THE NITROGLYCERIN WITH NO RELIEF. THE PATIENT PRESENTED TO THE EMERGENCY ROOM AND WAS REHOSPITALIZED. ON (B) (6) 2010, THE PATIENT UNDERWENT SUCCESSFUL CUTTING BALLOON ANGIOPLASTY IN BOTH THE OM AND CX ARTERIES TO TREAT IN-STENT RESTENOSIS. THERE IS NO ADDITIONAL INFORMATION 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 9072141

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization| R STENT: 3.0 X 15 MM XIENCE V (PART 1009541-15,| LOT 8102361)