BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 1920345 · Received December 10, 2010

    Report

    Report Number
    2953144-2010-03190
    Event Type
    Injury
    Date Received
    December 10, 2010
    Date of Event
    November 1, 2010
    Report Date
    November 18, 2010
    Manufacturer
    AV-REDWOOD CITY
    Product Code
    MGB
    PMA / PMN Number
    P050007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION OF THE RETURNED DEVICE FOUND THE DEVICE WAS PARTIALLY DEPLOYED WITH THE CLIP VISIBLE AND STILL LOADED ON THE CARRIER TUBE. INTERNAL INSPECTION FOUND 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. REVIEW OF THE DEVICE HISTORY RECORD FOR THIS LOT DID NOT PRODUCE ANY FINDINGS RELEVANT TO THIS REPORT. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. (B)(4) - FAILURE TO FOLLOW INSTRUCTIONS. (DATE OF THE EVENT): THE FACILITY REPORTER INDICATED THE EVENT OCCURRED THIS MONTH; THEREFORE, DATE OF (B)(6) 2010 IS BEING USED AS BEST ESTIMATE DATE. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA A TRIAL THAT ON (B)(6) 2008, THE PATIENT UNDERWENT STENTING IN THE SAPHENOUS VEIN GRAFT WITH THREE XIENCE V STENTS, TWO 4.0 X 28 MM AND ONE 4.0 X 18 MM. ON (B)(6) 2010, THE PATIENT EXPERIENCE NAUSEA, VOMITING, SHORTNESS OF BREATH WITH EXERTION AND SHORT EPISODES OF CHEST PRESSURE. ON (B)(6) 2010, THE PATIENT UNDERWENT PERCUTANEOUS CORONARY REVASCULARIZATION OF THE INDEX TARGET LESION FOR IN-STENT RESTENOSIS. THE PATIENT'S CONDITION RESOLVED AND THE PATIENT WAS DISCHARGED THE FOLLOWING DAY. THERE WAS NO ADVERSE PATIENT SEQUELA. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS 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 AN UNSPECIFIED VESSEL AFTER AN UNSPECIFIED PROCEDURE. REPORTEDLY, THE PHYSICIAN WAS UNABLE TO ADVANCE THE THUMB ADVANCER ALL THE WAY. RESISTANCE WAS FELT AND THE SHEATH WOULD NOT COMPLETELY SPLIT AND GOT 5MM FROM THE END. THE DEVICE WAS PULLED OUT AND MANUAL COMPRESSION WAS APPLIED FOR AN UNSPECIFIED PERIOD OF TIME TO ACHIEVE HEMOSTASIS. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT. 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 920316H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention