BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AORTIC MOLDING AND OCCLUSION BALLOON CATHETER (MOB)

    MDR report key: 9886843 · Received March 26, 2020

    Report

    Report Number
    3007284313-2020-00079
    Event Type
    Injury
    Date Received
    March 26, 2020
    Date of Event
    March 13, 2020
    Report Date
    March 13, 2020
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    DQY
    UDI-DI
    00733132639489
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PMA/510(K) #K172567. A REVIEW OF THE MANUFACTURING RECORDS FOR THE DEVICE(S) VERIFIED THAT THE LOT(S) MET ALL PRE-RELEASE SPECIFICATIONS.

    Description of Event or Problem · 1

    ON (B)(6) 2020, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM AND WAS IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESES FEATURING® DELIVERY SYSTEM. THE TRUNK IPSILATERAL LEG COMPONENT WAS ADVANCED INTO POSITION VIA A GORE® DRYSEAL FLEX INTRODUCER SHEATH; HOWEVER WHEN DEPLOYED, THE INTRODUCER SHEATH HAD NOT BEEN COMPLETELY WITHDRAWN BACK TO THE LIGHT COLORED SHAFT MARKER ON THE DELIVERY CATHETER AND THE IPSILATERAL LEG DEPLOYED WITHIN THE SHEATH. THE PHYSICIAN THEN CHOSE TO CANNULATE THE CONTRALATERAL GATE WITH THE SHEATH STILL IN PLACE BUT MET WITH DIFFICULTY DUE TO THE NARROWNESS OF THE DATE DUE TO PATIENT ANATOMY. AFTER MULTIPLE ATTEMPTS, SUCCESSFUL CANNULATION OF THE GATE WAS ACHIEVED AND THE DELIVERY CATHETER WAS REMOVED FROM THE PATIENT. THE PHYSICIAN THEN CUT THE TRAILING END OF THE (LOCKING MECHANISM) OF THE DILATOR OF THE SHEATH AND INSERTED IT FROM THE TRAILING AND PUSHED THE IPSILATERAL LEG OUT OF THE SHEATH AND SUCCESSFULLY DEPLOYED IN THE LEFT COMMON ILIAC ARTERY. POST DEPLOYMENT OF ALL THE DEVICES TOUCH UP ANGIOPLASTY WAS PERFORMED THROUGHOUT THE ENTIRE SYSTEM WITH A GORE® MOLDING & OCCLUSION BALLOON. FINAL ANGIOGRAPHY WAS PERFORMED AND IDENTIFIED A TYPE II ENDOLEAK AND A DISSECTION IMMEDIATELY PROXIMAL TO THE TRUNK. A GORE® AORTIC EXTENDER COMPONENT WAS IMPLANTED PROXIMALLY TO EXTEND COVERAGE AND TREAT THE DISSECTION. AT THE CONCLUSION OF THE PROCEDURE A SLIGHT DISSECTION REMAINED. THE PHYSICIAN REPORTED THAT THE DISSECTION MAY HAVE BEEN CAUSED BY CALCIFICATION IN THE PATIENT'S PROXIMAL NECK, TOUCH UP ANGIOPLASTY AND THE COMPLICATIONS ASSOCIATED WITH THE IPSILATERAL LEG DEPLOYMENT. THE PATIENT TOLERATED THE PROCEDURE AND WILL BE MONITORED BY THE PHYSICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349865 AORTIC MOLDING AND OCCLUSION BALLOON CATHETER (MOB) CATHETER, PERCUTANEOUS DQY W.L. GORE & ASSOCIATES MOB37 21409738 00733132639489

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR Hospitalization| O