BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6F ANGIO-SEAL VIP VASCULAR CLOSURE DEVICE, OUS

    MDR report key: 7037937 · Received November 16, 2017

    Report

    Report Number
    3013394970-2017-00559
    Event Type
    Injury
    Date Received
    November 16, 2017
    Date of Event
    December 28, 2015
    Report Date
    November 16, 2017
    Manufacturer
    TERUMO MEDICAL CORPORATION
    Product Code
    MGB
    PMA / PMN Number
    P930038
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE WAS NOT RETURNED TO THE MANUFACTURING FACILITY FOR EVALUATION. THE INVESTIGATION IS CURRENTLY ONGOING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE. FOR THIS REASON, (B)(4) HAS BEEN REFERENCED IN THE CONCLUSIONS SECTION OF EVALUATION CODES. THE PRODUCTION LOT NUMBER WAS NOT PROVIDED BY THE USER FACILITY, WHICH PREVENTED A MEANINGFUL REVIEW OF THE DEVICE HISTORY RECORD AND COMPLAINT FILES.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING SUBMITTED AS FOLLOW UP NO. 1 TO PROVIDE THE COMPLETED INVESTIGATION RESULTS. THE EVALUATION OF THE ACTUAL DEVICE COULD NOT BE CONDUCTED DUE TO THE DEVICE NOT BEING RETURNED.

    Description of Event or Problem · 1

    THE FOLLOWING EVENT WAS REPORTED IN CARDIOVASC INTERVENT RADIOL. 2017 JUN;40(6):942-946. DOI: 10.1007/S00270-017-1565-9. A (B)(6) MALE PATIENT PRESENTED TO THE OUTPATIENT CLINIC OF VASCULAR MEDICINE DUE TO AN ULCER LOCALIZED AT THE RIGHT METATARSOPHALANGEAL JOINT OF THE FIFTH TOE. MAGNETIC RESONANCE ANGIOGRAPHY OF THE PELVIC AND LEG ARTERIES REVEALED MULTIPLE STENOSES OF THE RIGHT SUPERFICIAL FEMORAL ARTERY, THE TIBIOPERONEAL TRUNK WITH A SINGLE-VESSEL RUNOFF VIA THE POSTERIOR TIBIAL ARTERY. HENCE, WE DECIDED TO PERFORM A PERIPHERAL ANGIOPLASTY OF THE RIGHT LEG. VIA ANTEGRADE PERCUTANEOUS ACCESS IN THE RIGHT GROIN, A SIX FRENCH INTRODUCER SHEATH WAS INSERTED WITH ULTRASOUND GUIDANCE INTO THE RIGHT COMMON FEMORAL ARTERY. THE APPROPRIATE ACCESS SITE WAS FINALLY CONFIRMED WITH FLUOROSCOPIC CONTROL. ANGIOGRAPHY CONFIRMED MULTISEGMENTAL HIGH-GRADE STENOSES OF THE RIGHT SUPERFICIAL FEMORAL ARTERY, POPLITEAL ARTERY AND THE TIBIOPERONEAL TRUNK WITH A ONEVESSEL RUNOFF VIA THE POSTERIOR TIBIAL ARTERY. FEMORO-POPLITEAL LESIONS WERE TREATED USING DRUG-COATED BALLOONS, WHEREAS ANGIOPLASTY WITH PLAIN BALLOONS WAS PERFORMED FOR INFRAPOPLITEAL LESIONS. AFTER REMOVAL OF ALL DEVICES, AN ANGIO-SEAL_ ST. JUDE MEDICAL DEVICE WAS USED TO CLOSE THE VASCULAR PUNCTURE SITE ACCORDING TO THE MANUFACTURER'S INSTRUCTIONS FOR USE. AFTER PLACING THE ARTERIOTOMY LOCATOR/INSERTION SHEATH AND INSERTING THE CARRIER TUBE INTO THE INSERTION SHEATH, WE PULLED ON THE DEVICE HANDLE UNTIL RESISTANCE FROM THE ANCHOR CATCHING ON THE DISTAL TIP OF THE INSERTION SHEATH WAS FELT. THE DEVICE HANDLE WAS PULLED BACK SLOWLY UNTIL HEMOSTASIS WAS ACHIEVED AND THE SUTURE WAS CUT BELOW THE SKIN LEVEL. THE PATIENT HAD AN EXTRAORDINARY THIN BODY CONSTITUTION. UNFORTUNATELY, THE CUT WAS PERFORMED WITHIN THE COLLAGEN SPONGE WHICH LED TO EMBOLIZATION OF THE ANCHOR. AS HEMOSTASIS WAS NO LONGER SUFFICIENT, MANUAL COMPRESSION FOR 15 MIN AND A COMPRESSION BANDAGE WERE APPLIED TO THE PUNCTURE SITE. POSTINTERVENTIONAL COLOR-CODED DUPLEX ULTRASONOGRAPHY OF THE AFFECTED LEG CONFIRMED AN OBSTRUCTION OF THE PROXIMAL POSTERIOR TIBIAL ARTERY DUE TO THE EMBOLIZED POLYMER ANCHOR OF THE ANGIO-SEAL CLOSURE DEVICE. THE PATIENT CONTINUED WITH THE ALREADY PRIOR TO THE INTERVENTION GIVEN ANTIPLATELET THERAPY OF 75 MG CLOPIDOGREL DAILY. FURTHERMORE, WE STARTED THERAPEUTIC ANTICOAGULATION WITH LOW MOLECULAR WEIGHT HEPARIN (ENOXAPARIN ONE MG PER KG BODY WEIGHT TWICE DAILY). NO NEWLY EMERGED SYMPTOMS OCCURRED IN THE PATIENT AFTER THAT EMBOLISM. AS THE OBSTRUCTION SEEMED HEMODYNAMICALLY RELEVANT, WE DECIDED TOWARD AN ENDOVASCULAR EMBOLECTOMY APPROACH. AFTER ULTRASOUND-GUIDED REPEATED. PERCUTANEOUS ACCESS IN THE RIGHT GROIN, WE INSERTED A SIX FRENCH INTRODUCER SHEATH INTO THE RIGHT COMMON FEMORAL ARTERY IN CONTRAST TO THE PRECEDING VASCULAR IMAGING BY DUPLEX ULTRASONOGRAPHY AND MR, THE RIGHT PROXIMAL POSTERIOR TIBIAL ARTERY WAS PATENT, BUT A NEW FILLING DEFECT WAS OBSERVED IN THE RIGHT DISTAL POSTERIOR TIBIAL ARTERY AT THE LEVEL OF THE ANKLE. THAT NEW FILLING DEFECT CORRESPONDED TO A FURTHER DISTAL EMBOLIZATION OF THE ANGIO-SEAL POLYMER ANCHOR. IN ORDER TO EVALUATE THE ANCHOR'S BEST RETRIEVING METHOD, WE EXTRACTED THE ANCHOR OF ANOTHER STERILE ANGIO-SEAL_DEVICE AND TRIED TO ASPIRATE THE ANCHOR FROM A WATER-FILLED CUP USING DIFFERENT ASPIRATION CATHETERS OF VARIOUS SIZE (FOUR TO SEVEN FRENCH). THE CURVED CONFIGURATION OF BOTH ANCHOR ENDS PREVENTED A SUCCESSFUL ASPIRATION OF THE ANCHOR INDEPENDENT TO THE SIZE OF THE ASPIRATION CATHETER. THEREFORE, WE DECIDED TO RETRIEVE THE ANCHOR USING A FILTER SYSTEM. AFTER PASSING THE ANGIO-SEAL ANCHOR WITH A 0.014-INCH GUIDE WIRE, A 4-MM SPIDERFX EMBOLIC PROTECTION DEVICE WAS RELEASED DISTALLY TO THE EMBOLIZED ANCHOR. THE SMALL SIZE OF THE FILTER WAS SELECTED BECAUSE OF THE SMALL REFERENCE VESSEL DIAMETER OF THE POSTERIOR TIBIAL ARTERY. THE FILTER SYSTEM WAS PULLED BACK, AND THE SEALING ANCHOR RETRIEVAL WAS SUCCESSFUL. VASOSPASM WAS OBSERVED IN THE POST INTERVENTIONAL ANGIOGRAPHY CONTROL WHICH WAS SUCCESSFULLY TREATED WITH INTRA-ARTERIAL APPLICATION OF 10 MG NIMODIPINE AND SUBSEQUENT INTRAVENOUS PROSTANOID INFUSION OVER THE NEXT 48 H. UNFRACTIONATED HEPARIN WAS ADMINISTERED UNDER CONTROL OF ACTIVATED CLOTTING TIME FOR 48 H AFTER SHEATH REMOVAL. NO FURTHER COMPLICATIONS OCCURRED. POSTINTERVENTIONAL COLOR CODED DUPLEX ULTRASONOGRAPHY CONFIRMED A PATENT POSTERIOR TIBIAL ARTERY OF THE AFFECTED SIDE, ESPECIALLY AT THE MALLEOLAR REGION.

    Description of Event or Problem · 1

    ON (B)(6) 2015, BEFORE THE REMOVAL OF THE ANGIO-SEAL, AN ULTRASOUND AND AN MR ANGIOGRAM WERE PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    817235 6F ANGIO-SEAL VIP VASCULAR CLOSURE DEVICE, OUS DEVICE, HEMOSTASIS, VASCULAR MGB TERUMO MEDICAL CORPORATION N/A UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention