BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 8667788 · Received June 4, 2019

    Report

    Report Number
    2024168-2019-04370
    Event Type
    Injury
    Date Received
    June 4, 2019
    Date of Event
    May 14, 2019
    Report Date
    July 22, 2019
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE CODES: 4001 LABELED. INTERNAL FILE NUMBER - 379040/1-1 CORRECTIONS: OUTCOMES ATTRIBUTED TO ADVERSE EVENT - UNCHECKED HOSPITALIZATION BOX; MFR SITE -REG#; DEVICE CODE 2993 REMOVED. THE DEVICE WAS NOT RETURNED FOR ANALYSIS. A REVIEW OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY OF THE REPORTED LOT COULD NOT BE CONDUCTED BECAUSE THE LOT NUMBER WAS NOT PROVIDED. THE PATIENT EFFECT OF OCCLUSION AND THE TREATMENT OF SURGICAL EXPOSURE ARE LISTED IN THE INSTRUCTIONS FOR USE (IFU) AS POTENTIAL ADVERSE EVENTS OF USE OF THE DEVICE. THE INVESTIGATION WAS UNABLE TO DETERMINE A CONCLUSIVE CAUSE FOR THE REPORTED DIFFICULTIES; HOWEVER, THE TREATMENT APPEARS TO BE RELATED TO CIRCUMSTANCES OF THE PROCEDURE. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE. THE OTHER PROGLIDE DEVICE REFERENCED IN B5 IS FILED UNDER A SEPARATE MEDWATCH REPORT NUMBER.

    Description of Event or Problem · 0

    SUBSEQUENT TO THE PREVIOUSLY FILED REPORT, ADDITIONAL INFORMATION WAS RECEIVED: IT WAS REPORTED THAT SUTURE PLACEMENT IN THE CALCIFIED RIGHT COMMON FEMORAL ARTERY WAS PERFORMED WITH TWO PROGLIDE DEVICES USING THE PRE-CLOSE TECHNIQUE VIA A 6F SHEATH PRIOR TO A TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI) INTERVENTIONAL PROCEDURE. THE SHEATH WAS UPSIZED TO A 18F AND THE TAVI PROCEDURE WAS COMPLETED. HEMOSTASIS WAS NOT FULLY ACHIEVED WITH THE PRE-PLACED PROGLIDE SUTURES; THEREFORE, A NON-ABBOTT CLOSURE DEVICE WAS USED TO ACHIEVE HEMOSTASIS. REPORTEDLY, THE OCCLUSION WAS DUE TO ANTERIOR WALL EVERSION WITH THE SHEATH. THERE WAS A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. HOSPITALIZATION WAS PROLONGED DUE TO EMBOLIC STROKE. PER PHYSICIAN, THE PROGLIDE DEVICE DID NOT CAUSE OR CONTRIBUTE TO STROKE OR PROLONGED HOSPITALIZATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE CUSTOMER REPORTED THE DEVICE IS NOT RETURNING. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ARTERIOTOMY CLOSURE OF THE RIGHT COMMON FEMORAL ARTERY WAS PERFORMED USING A PROGLIDE DEVICE AND AN ANGIOSEAL CLOSURE DEVICE. REPORTEDLY, AN OCCLUSION OF THE RIGHT FEMORAL ARTERY OCCURRED DUE TO THE PROGLIDE AND ANGIOSEAL CLOSURE DEVICES. SEVERAL ATTEMPTS WERE MADE WITH DIFFERENT GUIDES; HOWEVER, THE OCCLUSION DID NOT RESOLVE AND THE PATIENT WAS TRANSFERRED TO SURGERY. SURGICAL REPAIR OF THE FEMORAL TRIPOD THROUGH LONGITUDINAL ARTERIOTOMY CLOSURE WITH A BOVINE PERICARDIUM PATCH WAS PERFORMED. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE OR THERAPY. REPORTEDLY HOSPITALIZATION WAS PROLONGED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    462361 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Hospitalization| R SHEATH: 6F, 18FHEPARINPERCLOSE PROGLIDE