BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPLATZER VASCULAR PLUG 4

    MDR report key: 6522304 · Received April 26, 2017

    Report

    Report Number
    2135147-2017-00051
    Event Type
    Injury
    Date Received
    April 26, 2017
    Report Date
    April 26, 2017
    Manufacturer
    AGA MEDICAL CORPORATION
    Product Code
    KRD
    PMA / PMN Number
    K113658
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UDI: UNKNOWN SINCE THE BATCH/LOT NUMBER WAS NOT PROVIDED. (B)(4). THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. A REVIEW OF THE DEVICE HISTORY RECORD WAS NOT POSSIBLE SINCE THE SERIAL NUMBER WAS UNAVAILABLE. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 1

    JAPANESE JOURNAL OF CLINICAL RADIOLOGY 62: 483-488, 2017 TITLE: RECANALIZATION AFTER TRANSCATHETER ARTERIAL EMBOLIZATION USING AVP4 FOR TRAUMATIC RENAL INJURY SUMMARY: AVP4 IS AN ESTABLISHED EMBOLIC DEVICE WITH HIGH RESISTANCE TO MIGRATION AND A LOW RECANALIZATION RATE. THIS DEVICE CAN BE DELIVERED THROUGH A 4F DIAGNOSTIC CATHETER WITH SEVERAL ADVANTAGES SUCH AS SHORTENING OF PROCEDURE TIME, IMPROVEMENT OF SAFETY, REDUCTION OF RADIATION EXPOSURE DOSE, AND COST SAVING. WE HAVE EXPERIENCED ONE CASE WHICH SHOWED RECANALIZATION AFTER TRANSCATHETER ARTERIAL EMBOLIZATION USING AVP4 FOR TRAUMATIC RENAL INJURY. THE FOLLOWING INFORMATION COMES FROM THE ABSTRACT OF THE "JAPANESE JOURNAL OF CLINICAL RADIOLOGY " AS ABOVE. WE OBTAINED THIS INFORMATION (AVAILABLE ONLY IN JAPANESE) THROUGH A WEEKLY DOCUMENT RETRIEVAL SERVICE FROM AN OUTSOURCING COMPANY. THE PATIENT WAS FOUND TO HAVE FALLEN ON THE STREET AFTER DRINKING HEAVY ALCOHOL, THEN HE WAS TRANSFERRED TO AN EMERGENCY ROOM. A SIGNIFICANT RENAL TRAUMA ON THE RIGHT SIDE, HEPATIC TRAUMA, AND RIB FRACTURE WERE CONFIRMED. A DIAMETER OF A MAIN TRUNK OF RIGHT RENAL ARTERY (RT-RA) WAS MEASURED AT 4.2 MM. HOWEVER A COMPUTED TOMOGRAPHY (CT) DID NOT REVEAL THE INFERIOR PART OF A RENAL PARENCHYMA. THE ORIGIN OF DORSAL RT-RA BECAME RUPTURED AND EXTRAVASATION OF SUPERIOR RT-RA WAS CONFIRMED AS WELL. AS AN EMERGENCY TREATMENT WAS REQUIRED, AN ANGIOGRAPHY WAS IMMEDIATELY PERFORMED ON THE DAY OF ADMISSION. A CONSERVATIVE TREATMENT WAS SELECTED FOR THE RIB FRACTURE AND HEPATIC INJURY. ON AN UNKNOWN DATE, THE INITIAL TRANSCATHETER ARTERIAL EMBOLIZATION (TAE) WAS PERFORMED. AN ANGIOGRAPHY WAS PERFORMED AND A SPASM APPEARED TOTALLY IN THE RT-RA. INITIALLY, THE DORSAL RT-RA WAS EMBOLIZED USING NON-SJM DETACHABLE COILS. HOWEVER, AS THE POSSIBILITY RANGE FOR THE DEPLOYMENT OF THE DETACHABLE COILS WAS SHORT IN THE DORSAL ARTERY, ADDITIONAL COILS WERE UNABLE TO BE DEPLOYED AT THE SAME SITE. THEREFORE, N-BUTYL-2-CYANOACRYLATE (NBCA) WAS INFUSED INTO THE IMPLANTED COILS. THE SUPERIOR RT-RA WAS ALSO EMBOLIZED WITH NON-SJM DETACHABLE COILS. THE INFERIOR RT-RA WAS CONSERVATIVELY TREATED THIS TIME. ON THE 18TH DAY AFTER INITIAL TAE, THE PATIENT HAD AN UPPER ABDOMINAL PAIN. A CT REVEALED A PSEUDOANEURYSM AT THE SAME SITE OF ORIGIN OF DORSAL RT-RA. A COMMON BILE DUCT STONE (CBDS) WAS FOUND ALSO. THESE INCIDENTS WERE ASSUMED TO BE CAUSED BY ABDOMINAL PAIN DUE TO CBDS WITH OBSTRUCTIVE JAUNDICE (OJ). THEN AN ENDOSCOPIC NASO-BILIARY DRAINAGE (ENBD) WAS CONDUCTED. NO TREATMENT FOR THE PSEUDOANEURYSM WAS PROVIDED AND IT HAD BEEN MONITORED AT THE MOMENT. ON THE 23RD DAY AFTER INITIAL TAE, THE ABDOMINAL PAIN GOT WORSE AND GROSS HEMATURIA WAS CONFIRMED. A RUPTURED PSEUDOANEURYSM WAS DIAGNOSED THROUGH A CT. THE MAIN TRUNK OF RT-RA IN DIAMETER WAS REPORTED TO BE 4.0 MM. ON AN UNKNOWN DATE, THE SECOND TAE WAS PERFORMED. A RECANALIZATION WAS CONFIRMED AT THE RUPTURED ORIGIN OF DORSAL RT-RA WHERE THE COIL EMBOLIZATION WAS PERFORMED WITH NBCA AT THE TIME OF INITIAL TAE. AN ADDITIONAL COIL EMBOLISATION WAS CONSIDERED TO BE DIFFICULT AS THE INFERIOR RT-RA AND ITS MAIN TRUNK WERE LOCATED CLOSE TO THE RUPTURED SITE, THE ORIGIN OF DORSAL RT-RA. A 6 MM AVP4 (MODEL: 9-AVP038-006, LOT UNKNOWN) WAS IMPLANTED IN THE MAIN TRUNK OF THE RT-RA. THE EMBOLIZATION WAS COMPLETELY ACHIEVED. THE 42ND DAY AFTER THE SECOND TAE, A CT WAS PERFORMED. AFTER DEPLOYMENT OF AVP4, THE COMPLETE OCCLUSION HAD BEEN OBTAINED. THE DIAMETER OF MAIN TRUNK OF RT-RA BECAME 4.5 MM. HOWEVER, THE INFERIOR RT-RA WAS FOUND TO BE RECANALIZED. ON THE 64TH AND 91ST DAY AFTER THE 2ND TAE, THE RECANALIZATION OF THE INFERIOR RT-RA WAS ALSO NOTED. A COLLATERAL CIRCULATION FROM PERIPHERAL VASCULAR WAS NOT OBVIOUSLY IDENTIFIED. AFTER THE SECOND TAE, THE DIAMETER OF THE MAIN TRUNK OF RT-RA WAS RESPECTIVELY 4.5 MM ON THE 64TH DAY AND 4.8 MM ON THE 91 DAY. DUE TO RELIEF FROM THE SPASM, THE CONSTRICTED MAIN TRUNK SEEMED TO BECOME DILATED AND RETURNED TO THE NORMAL DIAMETER. NEITHER MIGRATION NOR DEFORMATION OF AVP4 WAS NOTED. REPORTEDLY, THE SPASM HAD BEEN RELIEVED IN THE RUPTURED ARTERY AFTER THE SECOND TAE. THE CAUSE OF THE RECANALIZATION IN RT-RA AFTER AVP4 DEPLOYMENT WAS THAT THE VESSEL DIAMETER WAS LIKELY TO BECOME DILATED THAN AT THE TIME OF THE SECOND TAE. THUS, AVP DEVICES SHOULD BE CONTEMPLATED TO SELECT LARGER SIZE THAN THE RECOMMENDED IN JAPANESE IFU. ALTHOUGH ANY COLLATERAL CIRCULATION COULD NOT BE CONFIRMED ON THE CT FINDINGS IN THIS CASE, IT WAS DESIRABLE TO CONSIDER WHETHER ANY COLLATERAL CIRCULATION FROM THE PERIPHERAL ARTERY IS LIKELY TO DEVELOP WHEN THE FOLLOW-UP CT, ETC. WAS CONDUCTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    306214 AMPLATZER VASCULAR PLUG 4 ARTERIAL EMBOLIZATION DEVICE KRD AGA MEDICAL CORPORATION 9-AVP038-006 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Hospitalization| R