BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1730380 · Received June 18, 2010

    Report

    Report Number
    2024168-2010-01194
    Event Type
    Injury
    Date Received
    June 18, 2010
    Date of Event
    February 18, 2010
    Report Date
    May 22, 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). (B)(4). THERE WAS NO REPORTED PRODUCT DEFICIENCY. RESTENOSIS IS A KNOWN ADVERSE EVENT AS LISTED IN THE XIENCE V INSTRUCTIONS FOR USE. 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 OR DESIGN. THE XIENCE V (PART 1009539-28, LOT 7100341), THE XIENCE V (PART 1009539-28, LOT 7101561), THE XIENCE V (PART 1009541-23, LOT 7102961), AND THE XIENCE V (PART 1009541-23, LOT 7102961), HAVE BEEN FILED UNDER A SEPARATE MFR NUMBER.

    Description of Event or Problem · 1

    DEVICE MALFUNCTION: NONE. ADVERSE EVENT: IN-STENT RESTENOSIS REQUIRING MEDICAL INTERVENTION. ONSET OF ADVERSE EVENT: APPROXIMATELY 19 MONTHS AFTER THE PROCEDURE. IT WAS REPORTED VIA A TRIAL THAT APPROXIMATELY 19 MONTHS POST PLACEMENT OF 5 XIENCE V STENTS IN THE MID AND DISTAL RIGHT CORONARY ARTERY (RCA), THE PATIENT REPORTED FATIGUE. ON (B)(6) 2010, A CUTTING BALLOON PROCEDURE WAS PERFORMED TO THE PROXIMAL, MID AND DISTAL RCA. 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 7103161

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention STENT: XIENCE V (PART 1009539-28, LOT 7100341)| XIENCE V (PART 1009541-23, LOT 7102961)| XIENCE V (PART 1009539-28, LOT 7101561)| XIENCE V (PART 1009541-23, LOT 7102961)