BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6F ANGIO-SEAL VASCULAR CLOSURE DEVICE STS PLUS

    MDR report key: 1242976 · Received November 20, 2008

    Report

    Report Number
    2182269-2008-00321
    Event Type
    Injury
    Date Received
    November 20, 2008
    Date of Event
    January 1, 2006
    Report Date
    November 20, 2008
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    MGB
    PMA / PMN Number
    P930038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED FOR EVALUATION AND REVIEW OF THE DEVICE HISTORY RECORD WAS NOT POSSIBLE SINCE THE LOT NUMBER WAS UNAVAILABLE. BASED ON THE INFORMATION PROVIDED TO ST. JUDE MEDICAL, THE CAUSE FOR THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED. THE ANGIO-SEAL INSTRUCTIONS FOR USE (IFU) STATES SHOULD ISCHEMIC SYMPTOMS APPEAR, TREATMENT OPTIONS INCLUDE THROMBOLYSIS, PERCUTANEOUS EXTRACTION OF THE ANCHOR OR FRAGMENTS, OR SURGICAL INTERVENTION. THE IFU INSTRUCTS THE USER ONCE A FULL REAR LOCK POSITION HAS BEEN ACHIEVED, AND THE DEVICE IS BEING DEPLOYED, TO NOT RE-INSERT THE DEVICE. RE-INSERTION OF THE DEVICE AFTER PARTIAL DEPLOYMENT COULD CAUSE COLLAGEN TO BE DEPOSITED IN THE ARTERY. THE IFU ALSO STATE FAILURE TO MAINTAIN TENSION ON THE SUTURE WHILE ADVANCING THE COLLAGEN COULD CAUSE THE COLLAGEN TO ENTER THE ARTERY.

    Description of Event or Problem · 1

    IT WAS REPORTED IN A PRINTED LITERATURE ARTICLE THAT THE PATIENT UNDERWENT URGENT INTERVENTION FOLLOWING A DIAGNOSTIC CARDIAC CATHETERIZATION WITH STENT PLACEMENT. THE SHEATH SIZE WAS BETWEEN 5 AND 7F. THE PATIENT PRESENTED WITH CLINICAL SIGNS OF ACUTE ARTERIAL OCCLUSION SUCH AS PAIN, PALENESS, COLDNESS, AND ABSENCE OF PERIPHERAL PULSE WITHIN TWO TO FOUR HOURS AFTER CATHETER INTERVENTION. DIAGNOSIS OF ARTERIAL OCCLUSION WAS MADE BY DUPLEX SCAN. THE PATIENT SHOWED OCCLUSION OR HIGH GRADE STENOSIS OF THE COMMON FEMORAL ARTERY. INTRAOPERATIVE FINDINGS CONSISTED OF A COMPETE ARTERIAL OCCLUSION WITH THE WHOLE ANGIO-SEAL DEVICE LOCATED INTRALUMINALLY IN THE FEMORAL ARTERY IN THE PATIENT CAUSING DISSECTION OF THE COMMON FEMORAL ARTERY. A COMPLETE ARTERIAL OCCLUSION DUE TO DISSECTION OF THE INTIMA WAS FOUND. A HIGH GRADE STENOSIS ARISING FROM INTRA-ARTERIAL DISLOCATION OF THE SEALING DEVICE OCCURRED. THE FEMORAL BIFURCATION HAD TO BE RECONSTRUCTED AFTER ENDARTERECTOMY USING A BOVINE PERICARDIAL PATCH. THIS WAS DUE TO EXTREME CALCIFICATION OF THE ARTERY AND DISSECTION. THE PATIENT UNDERWENT SUCCESSFUL SURGICAL INTERVENTION. AT 1-12 MONTHS LATER, FOLLOW UP WAS COMPLETED AND NO INTERVENTION WAS REQUIRED. THE IMPLANT, EXPLANT, AND EVENT DATES ARE BETWEEN EARLY AND LATE 2006. LITERATURE ARTICLE FROM VASCULAR AND ENDOVASCULAR SURGERY (2008) 42, 225-227.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 6F ANGIO-SEAL VASCULAR CLOSURE DEVICE STS PLUS ANGIO-SEAL DEVICE MGB ST. JUDE MEDICAL NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention