BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 1973073 · Received January 28, 2011

    Report

    Report Number
    2024168-2011-00515
    Event Type
    Injury
    Date Received
    January 28, 2011
    Date of Event
    January 3, 2011
    Report Date
    January 5, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. DEVICE CODE 2017 (OPERATOR NOT TRAINED IN USE OF PROGLIDE DEVICE) (AGE AT TIME OF EVENT): PATIENT WAS REPORTED TO BE IN HIS FIFTIES. (CONCOMITANT MEDICAL PRODUCTS): SHEATH: 6FR SHEATH, 18F SHEATH. OTHER: GORE DEVICE. THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. THE LOT NUMBER WAS NOT IDENTIFIED; THEREFORE, A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED. THE OTHER TWO PROGLIDES (PART#12673-03, LOT# UNKNOWN) ARE BEING REPORTED UNDER SEPARATE MANUFACTURER REPORT NUMBERS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN, NOT TRAINED IN THE USE OF THE PROGLIDE DEVICE, ATTEMPTED PRE-CLOSURE OF THE RIGHT COMMON FEMORAL ARTERY (RCFA) PRIOR TO AN ABDOMINAL AORTIC ANEURYSM (AAA) PROCEDURE. REPORTEDLY, 2 PROGLIDE DEVICES WERE EASILY DEPLOYED AFTER PLACEMENT OF A 6F SHEATH IN A PRE-CLOSE TECHNIQUE FASHION. THE ENDO GRAFT WAS PLACED. THE PROCEDURE WAS COMPLETED AND THE 18F SHEATH WAS REMOVED. BOTH OF THE CLOSURE DEVICE SUTURES FAILED TO CINCH DOWN OVER THE WIRE; THE KNOTS LOCKED. A THIRD PROGLIDE WAS PLACED BUT FAILED TO CATCH IN THE SETTING OF THE 18F ARTERIOTOMY. SURGICAL CUTDOWN WAS DONE AND A PURSE STRING SUTURE WAS PLACED DIRECTLY ON THE ARTERY TO ACHIEVE HEMOSTASIS. A DISSECTION IN THE ILIAC ARTERY, JUST DISTAL TO THE GRAFT, OCCURRED AND WAS TREATED WITH PLACEMENT OF AN ABBOTT STENT, HOWEVER, THE PATIENT DEVELOPED ACUTE LIMB ISCHEMIA WITHIN 12 HOURS. RCFA SURGICAL REPAIR WITH PERICARDIAL PATCH WAS SUCCESSFULLY PERFORMED AND THE PATIENT DID WELL. THE PRE-CLOSE OF THE LEFT CFA WENT FINE. ACCORDING TO THE PHYSICIAN, THERE WAS A 3 HOUR LAPSE BETWEEN THE DELIVERY OF THE PROGLIDES AND ATTEMPTED CLOSURE AND POSSIBLY THE SUTURE SHOULD HAVE BEEN WETTER AS THE SUTURES WERE NOT SOAKED AS MUCH AS USUAL PRIOR TO CLOSURE, WHICH MAY HAVE PLAYED A ROLE WITH ARTERIOTOMY CLOSURE. THE PHYSICIAN INDICATED HE BELIEVES CALCIFICATION OF THE ARTERY PLAYED A ROLE; THE VESSEL DISSECTION WAS LIKELY A COMBINATION OF THE PRE-CLOSE OF A CALCIFIED VESSEL TOGETHER WITH FIRM MANUAL COMPRESSION ON DISEASED ARTERY TO ACHIEVE HEMOSTASIS IN SETTING OF LARGE CALIBER SHEATH AND DISRUPTION OF THE ARTERY WITH PURSE STRING SUTURE. WITH ENDARTERECTOMY THE VESSEL WAS VERY FRIABLE. THOUGH REQUESTED, NO ADDITIONAL INFORMATION 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 AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention