BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM.

    MDR report key: 10515304 · Received September 10, 2020

    Report

    Report Number
    2024168-2020-07546
    Event Type
    Injury
    Date Received
    September 10, 2020
    Date of Event
    August 15, 2020
    Report Date
    October 7, 2020
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    D4: IT COULD NOT BE CONFIRMED WHICH LOT NUMBER THE REPORTED PROGLIDE HAD; THEREFORE, THE LOT HISTORY RECORD REVIEW ARE PROVIDED FOR BOTH REPORTED LOT NUMBERS. THE RESULTS ARE AS FOLLOWS: PART / LOT: 12673-05/ 0042041: DATE OF MANUFACTURE: 20-APRIL-2020 (H4) EXPIRATION DATE: 28-FEBRUARY-2022 (D4) UNIQUE DEVICE IDENTIFIER (UDI) NUMBER: (B)(4). PART / LOT: 12673-05/ 0020341: DATE OF MANUFACTURE: 03-FEBRUARY-2020 (H4) EXPIRATION DATE: 31-DECEMBER-2021 (D4) UNIQUE DEVICE IDENTIFIER (UDI) NUMBER: (B)(4). THE DEVICE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE MANUFACTURING RECORDS IDENTIFIED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOT THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. THE PATIENT EFFECTS OF HEMATOMA, PAIN AND PSEUDOANEURYSM ARE LISTED IN THE ELECTRONIC PERCLOSE PROGLIDE INSTRUCTIONS FOR USE AS POTENTIAL ADVERSE EVENTS OF USE OF THE DEVICE. A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT(S), AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED. HOWEVER, THE TREATMENT APPEARS TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE.NA

    Description of Event or Problem · 0

    CLINICAL STUDY PATIENT ID: (B)(4). IT WAS REPORTED THAT SUTURE PLACEMENT IN THE LEFT COMMON FEMORAL ARTERY WAS COMPLETED WITH TWO PROGLIDE DEVICES, USING THE PRE-CLOSE TECHNIQUE VIA A 6F SHEATH, PRIOR TO AN INTERVENTIONAL TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI). THE SHEATH WAS UPSIZED TO 15F AND THE PROCEDURE WAS COMPLETED. AFTER THE PROCEDURE, THE SUTURES OF THE TWO PROGLIDE DEVICES WERE ADVANCED SUCCESSFULLY; HOWEVER, AN ADDITIONAL PROGLIDE DEVICE WAS REQUIRED TO ACHIEVE FULL HEMOSTASIS OF THE LARGE HOLE CLOSURE. REPORTEDLY, APPROXIMATELY 36 HOURS AFTER HEMOSTASIS WAS ACHIEVED, A LEFT GROIN HEMATOMA DEVELOPED. THE PATIENT HAD ONGOING LEFT GROIN DISCOMFORT. THE PATIENT WAS REFERRED FOR ULTRASOUND THAT SHOWED THE HEMATOMA AND A SUSPECTED PSEUDOANEURYSM. COMPUTERIZED TOMOGRAPHY (CT) ANGIOGRAM CONFIRMED THE PSEUDOANEURYSM OF THE LEFT COMMON FEMORAL ARTERY. SURGICAL SUTURING WAS PERFORMED TO TREAT THE PSEUDOANEURYSM. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Additional Manufacturer Narrative · 1

    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

    CRD_909 THE CONFIDENCE REGISTRY STUDY REPORT PATIENT ID: (B)(6). IT WAS REPORTED THAT SUTURE PLACEMENT IN THE LEFT COMMON FEMORAL ARTERY WAS COMPLETED WITH TWO PROGLIDE DEVICES, USING THE PRE-CLOSE TECHNIQUE, VIA A 6F SHEATH PRIOR TO AN INTERVENTIONAL TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI) PROCEDURE. THE SHEATH WAS UPSIZED TO 15F FOR THE TAVI PROCEDURE. AFTER THE PROCEDURE, THE SUTURES OF THE TWO PROGLIDE DEVICES DID NOT ACHIEVE HEMOSTASIS OF THE LARGER HOLE. ANOTHER PROGLIDE DEVICE WAS USED AND HEMOSTASIS WAS ACHIEVED. REPORTEDLY, APPROXIMATELY 36 HOURS AFTER HEMOSTASIS WAS ACHIEVED, A LEFT GROIN HEMATOMA DEVELOPED. THE PATIENT HAD ONGOING LEFT GROIN DISCOMFORT. THE PATIENT WAS REFERRED FOR ULTRASOUND THAT SHOWED THE HEMATOMA AND A SUSPECTED PSEUDOANEURYSM. COMPUTERIZED TOMOGRAPHY (CT) ANGIOGRAM CONFIRMED THE PSEUDOANEURYSM OF THE LEFT COMMON FEMORAL ARTERY. SURGICAL SUTURING WAS PERFORMED TO TREAT THE PSEUDOANEURYSM. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    979140 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM. SUTURE MEDIATED CLOSURE MGB ABBOTT VASCULAR

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization| R SHEATH: 6F, HEPARIN| SHEATH: 6F, HEPARIN