BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPLATZER VASCULAR PLUG

    MDR report key: 7863991 · Received September 11, 2018

    Report

    Report Number
    2135147-2018-00147
    Event Type
    Injury
    Date Received
    September 11, 2018
    Report Date
    September 11, 2018
    Manufacturer
    AGA MEDICAL CORPORATION
    Product Code
    KRD
    PMA / PMN Number
    K031810
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVENT OF RESIDUAL SHUNT WAS REPORTED. THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 1

    DURING A PROCEDURE TO OCCLUDE A RELATIVELY LARGE DIAMETER AND SHORT AFFERENT VESSEL OF A SPLENIC ARTERY ANEURYSM IN A (B)(6) MALE PATIENT, THE AFFERENT SPLENIC ARTERY MEASURED ~9 MM IN DIAMETER AND ~8 MM IN LENGTH FROM ORIGIN TO START OF THE ANEURYSM. A 12 MM AMPLATZER VASCULAR PLUG (AVP) WAS SUCCESSFULLY DEPLOYED IN THE VESSEL. AFTER 5 MINUTES, PERSISTENT ANEURYSMAL PERFUSION REMAINED, SO THE USER ELECTED TO PACK THE AVP WITH MICROCOILS (OFF LABEL USE). A 1.7-F MICROCATHETER (EXCELSIOR SL-10; STRYKER NEUROVASCULAR, FREMONT, CALIFORNIA) AND A 0.014-INCH GUIDEWIRE (TRANSEND EX; STRYKER NEUROVASCULAR) WERE PASSED INTO THE AVP THROUGH ITS MESH. CELIAC ANGIOGRAPHY REVEALED INCOMPLETE OCCLUSION OF THE ANEURYSM AFTER PLACEMENT OF 8 0.014-INCH DETACHABLE COILS (TARGET XL 360 SOFT; STRYKER NEUROVASCULAR) INTO THE AVP 33 MINUTES AFTER AVP PLACEMENT. THEREFORE, 2 MORE COILS, TO GIVE A TOTAL OF 10 0.014-INCH DETACHABLE COILS (TARGET XL 360 SOFT; STRYKER NEUROVASCULAR) WITH A TOTAL LENGTH OF 215 CM WERE PACKED INTO THE AVP. IMMEDIATE ANGIOGRAPHY SHOWED OCCLUSION OF THE ANEURYSM AND PATENCY OF THE CELIAC AND HEPATIC ARTERIES. THERE WERE NO COMPLICATIONS DURING THE PROCEDURE. FOLLOW-UP CONTRAST-ENHANCED MAGNETIC RESONANCE IMAGING 41 DAYS AFTER EMBOLIZATION BY MEANS OF THE AVP AND MICROCOILS REVEALED THAT OCCLUSION OF THE ANEURYSM HAD BEEN ACHIEVED. NO CLINICAL SYMPTOMS WERE NOTED, AND LABORATORY TEST RESULTS WERE NORMAL. NO FURTHER INFORMATION IS EXPECTED TO BE RECEIVED OTHER THAN WHAT WAS PROVIDED IN THIS LITERATURE (DOI: HTTPS://DOI.ORG/10.1016/J.JVIR.2018.02.008).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    704962 AMPLATZER VASCULAR PLUG ARTERIAL EMBOLIZATION DEVICE KRD AGA MEDICAL CORPORATION 9-PLUG-012

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| R