BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 1915823 · Received December 6, 2010

    Report

    Report Number
    2953144-2010-03113
    Event Type
    Injury
    Date Received
    December 6, 2010
    Date of Event
    November 4, 2010
    Report Date
    November 11, 2010
    Manufacturer
    AV-REDWOOD CITY
    Product Code
    MGB
    PMA / PMN Number
    P050007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: EVALUATION OF THE RETURNED DEVICE FOUND A FULLY DISTALLY DEPLOYED DELIVERY TUBE SET; THE CLIP WAS NOT RETURNED. THE MOVEMENT OF AN INTERNAL COMPONENT (GARAGE BLOCK) WAS RESTRICTED WHICH RESULTED IN THE PROXIMAL DISPLACEMENT OF THE COMPONENTS TUBE AND EXPOSURE OF THE LOADED CLIP. THIS PREVENTED FURTHER DEPLOYMENT OF THE DEVICE AND THE CLIP BY LIMITING THE MOVEMENT OF THE CLIP PUSHER BLOCK/TUBE ASSEMBLY. THE PUSHER BLOCK DID NOT CONNECT WITH A COMPONENT AT THE DISTAL END OF THE RELEASE ROD TO COLLAPSE THE LOCATOR WINGS AND DISENGAGE THE PLUNGER DUE TO THE RESTRICTED MOVEMENT OF THE GARAGE BLOCK. THE ROOT CAUSE FOR THE RESTRICTED MOVEMENT OF THE GARAGE BLOCK AND SUBSEQUENT INABILITY TO DEPLOY THE CLIP IS DUE TO RESISTANCE ENCOUNTERED WHILE ADVANCING THE THUMB ADVANCER. RESISTANCE ENCOUNTERED DURING THUMB ADVANCER DEPLOYMENT IS CONSISTENT WITH RADIAL FORCE CONSTRICTION ON THE SHEATH. FACTORS THAT MAY CONTRIBUTE TO RADIAL FORCE CONSTRICTION MAY INCLUDE A TIGHT TISSUE TRACT OR ANATOMICAL CONDITIONS. THE INVESTIGATION IS ON-GOING. REVIEW OF THE DEVICE HISTORY RECORD DID NOT PRODUCE ANY FINDINGS RELEVANT TO THIS REPORT.

    Description of Event or Problem · 1

    PATIENT AND/OR DEVICE STATUS IS REPORTED TO THE EDWARDS LIFESCIENCES IMPLANT PATIENT REGISTRY. THIS REGISTRY IS A PATIENT TRACKING MECHANISM FOR SERIALIZED DEVICES (BIOPROSTHETIC HEART VALVES AND ANNULOPLASTY RINGS), RATHER THAN A TRUE POST-MARKET REGISTRY. THE INFORMATION IS RECEIVED FROM VARIOUS SOURCES (E.G. SURGEON, HOSPITAL, AND PATIENT FAMILY MEMBERS) AND IS NOT A CONVENTIONAL CUSTOMER COMPLAINT. IN THIS CASE, IT WAS REPORTED THAT THE DEVICE WAS EXPLANTED. THE DATE THE DEVICE WAS EXPLANTED WAS NOT PROVIDED. THROUGH FOLLOW-UP WITH THE HEALTHCARE PROVIDER, IT WAS LEARNED THAT THE DEVICE WAS EXPLANTED DUE TO CALCIFICATION. NO OTHER DETAILS WERE PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN TRAINED IN THE USE OF THE STARCLOSE SE DEVICE ATTEMPTED ARTERIOTOMY CLOSURE OF THE RIGHT COMMON FEMORAL ARTERY AFTER A DIAGNOSTIC PROCEDURE. REPORTEDLY, DURING DEPLOYMENT OF THE THUMB ADVANCER, STRONG RESISTANCE WAS MET. AFTER THE CLIP WAS DEPLOYED, THE DEVICE WAS DIFFICULT TO REMOVE. THE CLIP DID NOT ACHIEVE HEMOSTASIS AND MANUAL COMPRESSION WAS USED. THERE WAS NO ADVERSE PATIENT SEQUELA. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STARCLOSE SE VASCULAR CLOSURE SYSTEM IMPLANTABLE CLIP MGB AV-REDWOOD CITY 930016H

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention