BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 1902290 · Received November 11, 2010

    Report

    Report Number
    2953144-2010-02826
    Event Type
    Injury
    Date Received
    November 11, 2010
    Date of Event
    October 21, 2010
    Report Date
    October 21, 2010
    Manufacturer
    ABBOTT VASCULAR - VASCULAR SOLUTIONS
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION OF THE RETURNED DEVICE FOUND THAT THE PLUNGER, SUTURE, LINK, NEEDLES, AND CUFFS WERE NOT RETURNED. WITHOUT THE RETURN OF THE MISSING COMPONENTS, THE SCOPE OF THE INVESTIGATION WAS LIMITED. DURING TESTING, THE FOOT WAS SUCCESSFULLY RETRACTED AND DEPLOYED BY OPENING AND CLOSING THE LEVER AS DESIGNED. THERE WAS NO OBSERVABLE RESISTANCE TO SUGGEST THERE MIGHT HAVE BEEN DIFFICULTY RETRACTING THE FOOT TO REMOVE THE DEVICE. BECAUSE THE SUTURE WAS NOT RETURNED, IT COULD NOT BE CONFIRMED IF THE KNOT WAS SUCCESSFULLY DELIVERED TO THE ARTERIAL SURFACE TO CLOSE THE VESSEL. BASED ON THE INVESTIGATION FINDINGS, THE DEVICE PERFORMED ACCORDING TO SPECIFICATION AND THE ROOT CAUSE FOR THE REPORTED PRODUCT EXPERIENCE COULD NOT BE DETERMINED. PRIOR DEVICE CLOSURE IN THE TARGET GROIN COULD CONTRIBUTE TO THE REPORTED DIFFICULT DEVICE REMOVAL AND FAILURE TO CLOSE THE VESSEL WITH THE KNOT; HOWEVER, THIS COULD NOT BE CONFIRMED AS IT WAS UNKNOWN IF A PRIOR DEVICE CLOSURE WAS USED IN THE TARGET GROIN. NO MANUFACTURING OR QUALITY ISSUES WERE DETECTED. REVIEW OF THE DEVICE HISTORY RECORD FOR THIS LOT DID NOT PRODUCE ANY FINDINGS RELEVANT TO THIS REPORT.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6), 2010, IN THE PRESENCE OF STABLE ANGINA AND NOT IN THE PRESENCE OF ACUTE CORONARY SYNDROME, THE PATIENT UNDERWENT THE INDEX PROCEDURE WITH DEPLOYMENT OF TWO PROMUS STENTS IN THE PROXIMAL LEFT ASCENDING ARTERY. POST STENT DEPLOYMENT RESIDUAL STENOSIS WAS 0%. (THE PATIENT DID NOT RECEIVE A PERI PROCEDURAL LOADING DOSE OF CLOPIDOGREL. ON (B)(6), 2010, THE PATIENT BEGAN 75 MG CLOPIDOGREL DOSING. ON AN UNKNOWN DATE, THE PATIENT BEGAN ASPIRIN 325 MG DOSING.) ON (B)(6), 2010, THE PATIENT WAS DISCHARGED FROM THE INDEX PROCEDURE HOSPITALIZATION. ON (B)(6), 2010, THE PATIENT SUFFERED SUDDEN DEATH. THE CAUSE OF DEATH WAS REPORTED AS HYPERCAPNIC RESPIRATORY FAILURE. AN AUTOPSY WAS NOT PERFORMED. NO ADDITIONAL INFORMATION WAS PROVIDED. YOU ARE RECEIVING THIS MDR REPORT FROM ABBOTT VASCULAR BECAUSE (B)(4) DISTRIBUTES PROMUS AS ITS OWN BRAND LABELING OF ABBOTT VASCULAR'S DRUG ELUTING STENT IN THE US.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN TRAINED IN THE USE OF THE PERCLOSE PROGLIDE DEVICE ATTEMPTED ARTERIOTOMY CLOSURE OF THE RIGHT FEMORAL ARTERY AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, AS THE DEVICE WAS BEING REMOVED FROM THE ANATOMY, A LOT OF RESISTANCE WAS MET. AFTER READVANCING THE DEVICE AND CONFIRMING THE LEVER WAS IN THE PROPER POSITION, THE DEVICE WAS REMOVED WITH A LITTLE RESISTANCE. ALTHOUGH THE KNOT WAS DEPLOYED, HEMOSTASIS WAS NOT ACHIEVED AND MANUAL COMPRESSION WAS USED. THERE WAS NO ADVERSE PT SEQUELA. NO ADDITIONAL INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB ABBOTT VASCULAR - VASCULAR SOLUTIONS NA 910196H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention