BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1615213 · Received February 22, 2010

    Report

    Report Number
    2024168-2010-00331
    Event Type
    Injury
    Date Received
    February 22, 2010
    Date of Event
    January 28, 2010
    Report Date
    January 28, 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). CARDIAC ARREST, THROMBOSIS, AND HOSPITALIZATION ARE KNOWN ADVERSE EVENTS OF CORONARY STENTING AS LISTED IN THE XIENCE V IFU. THIS WAS AN AMI CASE. THE IFU STATES: "[ACCORDING TO THE CONDITION OF THE PT, THERE IS A POSSIBILITY OF THE OCCURRENCE OF COMPLICATION.] PTS WHO HAD RECENT AMI OR WHO HAVE NOT NORMALIZED THE CARDIAC ENZYME LEVELS AFTER AMI." ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PT EFFECTS AND THE RELATIONSHIP, IF ANY, TO THE DEVICE CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING. THE XIENCE V (PART 1009541-28, LOT 9101342), INDICATED HAS BEEN FILED UNDER THE SAME MFR #.

    Description of Event or Problem · 1

    REPORTING STATUS: SERIOUS INJURY-MEDICAL INTERVENTION. REPORTING RATIONALE: THROMBOSIS REQUIRING MEDICAL INTERVENTION. DEVICE ISSUE: NO DEVICE MALFUNCTION HAS BEEN REPORTED. IT WAS REPORTED THAT APPROXIMATELY ONE WEEK PRIOR TO THE DEPLOYMENT OF THE XIENCE V STENTS, TWO NON-ABBOTT STENTS WERE IMPLANTED IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD) AND STENT THROMBOSIS OCCURRED AROUND BOTH THE NON-ABBOTT STENTS. ON (B) (6) 2010, TWO XIENCE V STENTS WERE IMPLANTED IN AN ACUTE MYOCARDIAL INFARCTION (AMI) PT AND THE PERCUTANEOUS CORONARY INTERVENTION (PCI) WAS SUCCESSFUL. THE STENT DEPLOYMENT WAS CONFIRMED TO BE SATISFACTORY BY POST STENT DEPLOYMENT EXAMINATION WITH INTRA-VASCULAR ULTRASOUND (IVUS). STENT THROMBOSIS WAS NOTED OCCURRING 48 HOURS POST STENT DEPLOYMENT AND THE PT EXPERIENCED CARDIAC ARREST. THE THROMBOSIS WAS OBSERVED IN THE MID RIGHT CORONARY ARTERY (RCA), DISTAL TO THE XIENCE V IMPLANTED STENTS. AN INTRA-AORTIC BALLOON PUMP (IABP) WAS INSERTED AND PCPS WAS PLACED AND THE THROMBOSIS WAS ASPIRATED AND BALLOON ANGIOPLASTY WAS PERFORMED. AS OF (B) (6) 2010, THE PT REMAINED HOSPITALIZED AND IN STABLE CONDITION. THERE WERE NO REPORTED ADVERSE PT SEQUELAE. NO ADDITIONAL EVENT OR PT INFO IS 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 9100141

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| R (PART# 1009541-28, LOT 9101342)| STENT: 3.0 X 28 MM XIENCE V| ENDEAVOR| CYPHER