BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK 8F ANGIO-SEAL

    MDR report key: 9347966 · Received November 20, 2019

    Report

    Report Number
    3013394970-2019-00919
    Event Type
    Injury
    Date Received
    November 20, 2019
    Report Date
    November 20, 2019
    Manufacturer
    TERUMO MEDICAL CORPORATION
    Product Code
    MGB
    PMA / PMN Number
    P930038
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EXPIRATION DATE - UNKNOWN DUE TO UNKNOWN PRODUCT CODE AND LOT NUMBER. UDI - UNKNOWN DUE TO UNKNOWN PRODUCT CODE AND LOT NUMBER. IMPLANTED DATE: UNKNOWN DUE TO UNKNOWN DATE OF EVENT. EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. DEVICE MANUFACTURE DATE - UNKNOWN DUE TO UNKNOWN PRODUCT CODE AND LOT NUMBER. PHONE NUMBER- REQUESTED, NOT PROVIDED. THE ACTUAL DEVICE WAS NOT RETURNED; THEREFORE, AN EVALUATION OF THE ACTUAL DEVICE WAS UNABLE TO BE CONDUCTED. THE PRODUCTION LOT NUMBER WAS NOT PROVIDED BY THE USER FACILITY, WHICH PREVENTED A MEANINGFUL REVIEW OF THE DEVICE HISTORY RECORD. WITH NO RETURN OF THE ACTUAL DEVICE, THE EXACT CAUSE OF THE REPORTED EVENT CANNOT BE DEFINITIVELY DETERMINED BASED ON THE AVAILABLE INFORMATION.

    Description of Event or Problem · 1

    PER LITERATURE REVIEW: THE ARTICLE ENTITLED; SAFETY AND EFFICACY OF HYBRID VASCULAR CLOSURE TECHNIQUE USING BOTH A SUTURE- AND COLLAGEN-MEDIATED CLOSURE DEVICE AFTER TRANSFEMORAL TRANSCATHETER AORTIC VALVE IMPLANTATION. CATHETER CARDIOVASC INTERV. 2019;1-5. A CLINICAL STUDY WAS PERFORMED USING DATA THAT WAS OBTAINED RETROSPECTIVELY FROM A CONSECUTIVE, NONRANDOMIZED REGISTRY AT A SINGLE TAVI CENTER BETWEEN MAY 2018 AND NOVEMBER 2018. TAVI PROCEDURES WERE PERFORMED ON 75 PATIENTS TRANSFEMORAL, AFTER THE PROCEDURE WAS PERFORMED FEMORAL ARTERIES WERE CLOSED USING A COMBINATION OF SUTURE-MEDIATED CLOSURE DEVICE (PROGLIDE) IN CONJUNCTION WITH COLLAGEN-MEDIATED DEVICE (8FR ANGIO-SEAL). OF THE 75 PATIENTS, ONE PATIENT EXPERIENCED A RETROPERITONEAL BLEED THAT REQUIRED SURGICAL INTERVENTION. ALL PATIENTS UNDERWENT A PREPROCEDURAL CONTRAST-ENHANCED MULTI-SLICE COMPUTED TOMOGRAPHY (CT) WITH A DEDICATED TAVI PROTOCOL. THE CT IMAGES WERE ANALYZED USING DEDICATED SOFTWARE (3MENSIO, PIA MEDICAL IMAGING B.V., MAASTRICHT, THE NEDERLANDS). SMALLEST LUMEN DIAMETER WAS MEASURED IN TWO PLANES IN THE COMMON ILIAC ARTERY, EXTERNAL ILIAC ARTERY AND COMMON FEMORAL ARTERY. CALCIFICATION WAS VISUALLY GRADED AS NONE/MILD (=0) OR MODERATE/SEVERE (=1). ASSESSMENTS OF LUMEN DIAMETER AND CALCIUM SCORING WERE PERFORMED BY ONE OF THE TAVI OPERATORS. PRIOR TO THE LARGE BORE ARTERIOTOMY WE INTRODUCED A J-TIP WIRE IN A MORE DISTAL 4FR PUNCTURE IN THE IPSILATERAL FEMORAL ARTERY IN 67 PATIENTS. BY FLUOROSCOPIC GUIDANCE, AIMING AT THE J-TIP POSITIONED AT THE DESIRED PUNCTURE SITE, WE PUNCTURED THE COMMON FEMORAL ARTERY. IN EIGHT PATIENTS, WE USED ULTRASOUND GUIDED PUNCTURE IN THE COMMON FEMORAL ARTERY AND DID NOT USE THE DISTAL 4FR PUNCTURE. ONE PROGLIDE WAS DEPLOYED BEFORE INTRODUCING THE LARGE BORE SHEATH (SENTRANT, MEDTRONIC INC., MINNEAPOLIS, MN). AT THE END OF THE TAVI PROCEDURE, THE LARGE BORE SHEATH WAS REPLACED BY AN 8FR SHEATH OVER A 0,03500 GUIDEWIRE. THE PREPOSITIONED PROGLIDE-SUTURE WAS TIGHTENED OVER THE 8FR SHEATH AND FIXED. SUBSEQUENTLY, THE 8FR SHEATH WAS REMOVED AND AN 8FR ANGIO-SEAL WAS INSERTED TO OBTAIN FULL HEMOSTASIS. IF THERE WAS SIGNIFICANT ARTERIAL BLEEDING AROUND THE 8FR SHEATH, AN ADDITIONAL PROGLIDE WAS DELIVERED BEFORE USING THE 8FR ANGIO-SEAL. IN EACH PATIENT, WE PERFORMED CONTROL ANGIOGRAPHY BEFORE CLOSING THE DISTAL PUNCTURE SITE EITHER BY 6FR ANGIO-SEAL, MANUAL COMPRESSION OR FEMOSTOP (ST. JUDE MEDICAL, PLYMOUTH, MINNESOTA). THE PATIENTS WITH ONLY ONE PUNCTURE SITE AT THE FEMORAL ARTERY WERE CONTROLLED WITH ANGIOGRAPHY FROM THE RADIAL ARTERY OR CONTRALATERAL FEMORAL ARTERY. ALL PATIENTS RECEIVED DUAL ANTIPLATELET THERAPY THE DAY BEFORE PROCEDURE AND CONTINUED FOR 3 MONTHS AFTER TAVI. WHEN APPLICABLE, ANTICOAGULANTS WERE STOPPED 3 DAYS PRIOR TO THE TAVI PROCEDURE. INTRAVENOUS HEPARIN WAS ADMINISTERED TO ACHIEVE AN ACTIVATED CLOTTING TIME ABOVE 250 S. ALL PATIENTS WERE TREATED WITH A SELF-EXPANDABLE MEDTRONIC TAVI-BIOPROSTHESIS; EVOLUTR (N = 27) AND EVOLUT PRO (N = 48), (BOTH MEDTRONIC INC., MINNEAPOLIS, MN), AND RECEIVED PROTAMINE SULPHATE TO REVERSE THE HEPARIN EFFECT AT THE END OF THE PROCEDURE AND WAITED FOR FEW MINUTES BEFORE TIGHTENING OF PROGLIDE AND FINAL CLOSURE WITH ANGIO-SEAL. SUCCESSFUL HYBRID VASCULAR CLOSURE TECHNIQUE WAS DEFINED AS COMPLETE HEMOSTASIS WITHOUT THE NEED FOR FURTHER INTERVENTION AND WAS EVALUATED AT THE END OF PROCEDURE AND AT HOSPITAL DISCHARGE. TRANSIENT MANUAL COMPRESSION OR LOW PRESSURE FEMOSTOP (<60 MMHG) WAS NOT CONSIDERED FAILURE. UNSUCCESSFUL CLOSURE TECHNIQUE WAS DEFINED AS ACCESS SITE VASCULAR COMPLICATIONS INCLUDING BLEEDING, VESSEL OCCLUSION, FLOW LIMITING HIGH-GRADE STENOSIS OR DISSECTION, PSEUDOANEURYSM, NONPLANNED VASCULAR SURGERY, OR ENDOVASCULAR INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1142419 UNK 8F ANGIO-SEAL DEVICE, HEMOSTASIS, VASCULAR MGB TERUMO MEDICAL CORPORATION N/A UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention PROGLIDE CLOSURE DEVICE