BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK-CV-SR-ENDURANT

    MDR report key: 4910571 · Received July 13, 2015

    Report

    Report Number
    2953200-2015-00991
    Event Type
    Injury
    Date Received
    July 13, 2015
    Date of Event
    August 31, 2014
    Report Date
    June 18, 2015
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION OBTAINED FROM THE JOURNAL ARTICLE ENTITLED; EFFICACY AND SAFETY OF AUGMENTING THE PRECLOSE TECHNIQUE WITH A COLLAGEN-BASED CLOSURE DEVICE FOR PERCUTANEOUS ENDOVASCULAR ANEURYSM REPAIR. RAFIUDDIN PATEL, MACIEJ T. JUSZCZAK, MARK J. BRATBY , EDIRI SIDESO ,SUSAN ANTHONY , CHARLES R. TAPPING , ASHOK HANDA , CHRISTOPHER R. DARBY, JEREMY PERKINS , RAMAN UBEROI. DOI 10.1007/S00270-014-1004-0. A VALIANT AND ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF ENDOVASCULAR ANEURYSM REPAIR. DURING THE RETROSPECTIVE STUDY THE FOLLOWING ADVERSE EVENTS WERE OBSERVED: SURGICAL CONVERSION, HEMATOMA, PSEUDO ANEURYSM, BLEEDING. ABSTRACT PURPOSE TO REPORT OUR EXPERIENCE OF SELECTIVELY AUGMENTING THE PRECLOSE TECHNIQUE FOR PERCUTANEOUS ENDOVASCULAR ANEURYSM REPAIR (P-EVAR) WITH AN ANGIO-SEAL DEVICE AS A HAEMOSTATIC ADJUNCT IN CASES OF SIGNIFICANT BLEEDING AFTER TENSIONING THE SUTURES OF THE SUTURE-MEDIATED CLOSURE DEVICES. MATERIALS AND METHODS PROSPECTIVELY COLLECTED DATA FOR P-EVAR PATIENTS AT OUR INSTITUTE WERE ANALYSED. OUTCOMES INCLUDED TECHNICAL SUCCESS AND ACCESS SITE COMPLICATIONS. A LOGISTIC REGRESSION MODEL WAS USED TO ANALYSE THE EFFECTS OF SHEATH SIZE, CFA FEATURES AND STENT GRAFT TYPE ON PRIMARY FAILURE OF THE PRECLOSE TECHNIQUE NECESSITATING AUGMENTATION AND ALSO ON THE DEVELOPMENT OF COMPLICATIONS. RESULTS P-EVAR WAS ATTEMPTED VIA 122 CFA ACCESS SITES WITH A MEDIAN SHEATH SIZE OF 18-FRENCH (RANGE 12- TO 28-FRENCH). PRIMARY SUCCESS OF THE PRECLOSE TECHNIQUE WAS 75.4 % (92/122). ANGIO-SEAL AUGMENTATION WAS UTILISED AS AN ADJUNCT TO THE PRECLOSE TECHNIQUE IN 20.5 % (25/122). THE OVERALL P-EVAR SUCCESS RATE WAS 95.1 % (116/122). THERE WAS A STATISTICALLY SIGNIFICANT RELATIONSHIP (P = 0.0093) BETWEEN DEPTH OF CFA AND PRIMARY FAILURE OF PRECLOSE TECHNIQUE. CFA DIAMETER, CALCIFICATION, TYPE OF STENT GRAFT AND SHEATH SIZE DID NOT HAVE SIGNIFICANT EFFECTS ON PRIMARY PRECLOSE TECHNIQUE FAILURE. OVERALL 4.9 % (6/ 122) REQUIRED SURGICAL CONVERSION BUT OTHERWISE THERE WERE NO MAJOR COMPLICATIONS. CONCLUSION AUGMENTATION WITH AN ANGIO-SEAL DEVICE IS A SAFE AND EFFECTIVE ADJUNCT TO INCREASE THE SUCCESS RATE OF THE PRECLOSE TECHNIQUE IN P-EVAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    452261 UNK-CV-SR-ENDURANT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND UNK-CV-SR-ENDURANT

    Patients

    Seq Age Sex Outcome Treatment
    1 00079 YR Required Intervention