BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 10653206 · Received October 8, 2020

    Report

    Report Number
    2024168-2020-08421
    Event Type
    Injury
    Date Received
    October 8, 2020
    Date of Event
    June 18, 2020
    Report Date
    October 8, 2020
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    MGB
    UDI-DI
    08717648013089
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR ANALYSIS. A REVIEW OF THE MANUFACTURING RECORDS IDENTIFIED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOT THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. ADDITIONALLY, A REVIEW OF THE COMPLAINT HISTORY OF THE REPORTED LOT DID NOT INDICATE A LOT SPECIFIC QUALITY ISSUE. THE PATIENT EFFECT OF PSEUDOANEURYSM IS LISTED IN THE ELECTRONIC PERCLOSE PROGLIDE INSTRUCTIONS FOR USE AS A POTENTIAL ADVERSE EVENT 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. THE PATIENT EFFECT IS A POTENTIAL ADVERSE EVENT. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE. THE TWO ADDITIONAL PROGLIDE DEVICES REFERENCED IN B5 ARE FILED UNDER SEPARATE MEDWATCH REPORT NUMBERS. USER FACILITY MEDWATCH REPORT (UF/IMPORTER REPORT# 4900240000-2020-8070).

    Description of Event or Problem · 1

    USER FACILITY MEDWATCH REPORT (4900240000-2020-8070) WAS RECEIVED THAT STATES: " 6FR PERCLOSE PROGLIDE SUTURE MEDIATED CLOSURE SYSTEM (REF # (B)(4)) LOT# 0031141 EXP 2022-01-31 FAILED @ END OF PERCUTANEOUS FEVAR PROCEDURE IN HYBRID OR. THIS RESULTED IN EMERGENT CUTDOWN TO CONTROL BLEEDING FROM LEFT COMMON FEMORAL ARTERY. PER OPERATIVE REPORT, COMPLICATIONS: FAILED PRE-CLOSURE AND DIRECT MANUAL PRESSURE OF LEFT FEMORAL ARTERY REQUIRING OPEN EXPOSURE AND PRIMARY REPAIR. WHAT WAS THE ORIGINAL INTENDED PROCEDURE: FOUR VESSEL FENESTRATED- EVAR WITH PMEG ZFEN-P-2-28-124-R INCLUDING DISTAL BIFURCATE ZFEN-D-12-28-91-C WITH STENTED FENESTRATIONS FOR THE CELIAC, SMA AND BILATERAL RENAL ARTERIES. ((B)(4)). ULTRASOUND GUIDED ACCESS OF BILATERAL FEMORAL ARTERIES WITH PRECLOSURE OF 20 FR SHEATH ON THE RIGHT AND 14FR SHEATH ON THE LEFT. ((B)(4)) EXPOSURE OF LEFT COMMON FEMORAL ARTERY WITH PRIMARY REPAIR. ((B)(4)) RETROGRADE ACCESS OF THE RIGHT RADIAL WITH SELECTIVE CATHETERIZATION OF LEFT EXTERNAL ILIAC AND BALLOON ANGIOPLASTY FOR PROXIMAL CONTROL. ((B)(4)) WHAT PROBLEM DID THE USER HAVE (CHECK ALL THAT APPLY): DEVICE MALFUNCTION- THAT IS, THE DEVICE DID NOT DO WHAT IT WAS SUPPOSED TO DO." NO ADDITIONAL INFORMATION WAS PROVIDED. SUBSEQUENT TO RECEIVING THE USER FACILITY MEDWATCH REPORT, ADDITIONAL INFORMATION WAS RECEIVED: REPORTEDLY, THE SUTURES OF TWO PROGLIDE DEVICES WERE SUCCESSFULLY PRE-PLACED IN BOTH THE LEFT COMMON FEMORAL ARTERY (LCFA) AND THE RIGHT COMMON FEMORAL ARTERY (RCFA) USING THE PRE-CLOSE TECHNIQUE VIA A 6F SHEATH PRIOR TO A FENESTRATED ENDOVASCULAR AORTIC REPAIR (FEVAR) INTERVENTIONAL PROCEDURE. THE SHEATH WAS UPSIZED TO A 14F AND THE FEVAR PROCEDURE WAS COMPLETED. AFTER THE FEVAR INTERVENTIONAL PROCEDURE, THE PRE-PLACED SUTURES OF THE PROGLIDE DEVICES FAILED TO ACHIEVE HEMOSTASIS IN BOTH ACCESS SITES. PROTAMINE WAS ADMINISTERED AND DIRECT MANUAL PRESSURE WAS APPLIED TO BOTH ACCESS SITES (LCFA AND RCFA). HEMOSTASIS WAS ACHIEVED IN THE RIGHT COMMON FEMORAL ARTERY. HOWEVER, DESPITE 30 MINUTES OF DIRECT MANUAL PRESSURE TO THE ACCESS SITE IN THE LEFT COMMON FEMORAL ARTERY, ULTRASOUND IMAGING REVEALED A LARGE PSEUDOANEURYSM JUST ABOVE THE LEVEL OF THE HIGH LEFT COMMON FEMORAL ARTERY BIFURCATION. EMERGENT CUTDOWN SURGERY AND PRIMARY REPAIR WAS PERFORMED TO CONTROL THE BLEEDING FROM THE LCFA. "THE FEMORAL ARTERIOTOMY WAS PRIMARILY REPAIRED WITH 5-0 PROLENE IN A RUNNING FASHION. THE ARTERIES WERE THEN BACKBLED AND FORWARD FLUSHED. FLOW WAS THEN RESTORED TO THE PROFUNDO-FEMORAL ARTERY AND THEN ULTIMATELY TO THE SUPERFICIAL FEMORAL ARTERY. EXCELLENT HEMOSTASIS WAS OBTAINED AT THE ARTERIOTOMY SITE. EXCELLENT PULSES WERE NOTED WITHIN THE SFA AND PROFUNDO-FEMORAL ARTERY DISTAL TO THE PRIMARY REPAIR." THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE OR THERAPY. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1112379 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB ABBOTT VASCULAR 12673-03 0031141 08717648013089

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention