BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPLATZER VASCULAR PLUG 4

    MDR report key: 7120213 · Received December 14, 2017

    Report

    Report Number
    2135147-2017-00167
    Event Type
    Injury
    Date Received
    December 14, 2017
    Report Date
    December 14, 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

    AN EVENT OF "MASSIVE THROMBUS IN THE LEFT RENAL VEIN AND PULMONARY THROMBOEMBOLISM," WHICH "WERE ASSUMED TO BE CAUSED BY THE MARKEDLY DILATED VENOUS SAC DUE TO LONG-TERM HIGH FLOW OF RENAL AVF." 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

    THE FOLLOWING INFORMATION COMES FROM THE ABSTRACT OF THE (B)(6)/JOURNAL OF INTERVENTIONAL RADIOLOGY, VOL.32:204-208, 2017, TITLED, MASSIVE PULMONARY EMBOLIZATION AFTER EMBOLIZATION FOR RENAL ARTERIOVENOUS FISTULA WITH HUGE RENAL VEIN SAC. APPROXIMATELY 18 YEARS AGO, A FEMALE PATIENT WAS POINTED OUT URIC PROTEIN BY MEDICAL HEALTH CHECKUP. ALTHOUGH KIDNEY BIOPSY WAS CONDUCTED, NO TREATMENT WAS REQUIRED FOR THE PATIENT AS THERE WAS NO VISIBLE CAUSE FOR RENAL DISEASE. SINCE THEN, NO ANOMALIES WERE FOUND BY MEDICAL HEALTH CHECKUP AND THE PATIENT HAD BEEN ASYMPTOMATIC. WHEN THE PATIENT WAS IN HER THIRTIES, LEFT RENAL ANOMALIES WERE FOUND AND AN ABDOMINAL COMPUTED TOMOGRAPHIC SCAN WAS PERFORMED. A LEFT SIDE RENAL ARTERIOVENOUS FISTULA (AVF) OR RENAL ARTERIOVENOUS MALFORMATION (AVM) WAS SUSPECTED AND THE PATIENT WAS REFERRED TO DEPARTMENT OF RADIOLOGY TO UNDERGO AN EMBOLIZATION PROCEDURE. A CONTRAST ENHANCED CT REVEALED LEFT RENAL AVF WITH 7 MM IN DIAMETER, WHICH WAS LOCATED ON THE LOWER POLE OF THE LEFT KIDNEY. ALSO DILATED RENAL VENOUS SAC WITH 7 CM IN DIAMETER WAS NOTED ON THE MAIN TRUNK OF THE LEFT RENAL VEIN, WHICH BECAME NORMAL SIZED JUST UNDER THE SUPERIOR MESENTERIC ARTERY (SMA). NEITHER RIGHT CARDIAC FAILURE NOR THROMBUS WITHIN LEFT RENAL VEIN WAS OBSERVED. AN EMBOLIZATION OF LEFT RENAL AVF WAS SCHEDULED. DURING THE PROCEDURE, FEMORAL ARTERIES ON BOTH THE RIGHT AND LEFT SIDE, AND RIGHT FEMORAL VEIN WERE PUNCTURED. A 4.5F GUIDING SHEATH WAS PLACED IN THE RIGHT RENAL ARTERY VIA RIGHT FEMORAL ARTERY PUNCTURE, AN 8F SHEATH IN INFERIOR VENA CAVA VIA RIGHT FEMORAL VEIN PUNCTURE AND A 5F SHEATH IN AORTA VIA LEFT FEMORAL ARTERY PUNCTURE. IN ORDER TO PREVENT MIGRATION OF EMBOLIC DEVICES, A 5F SELECON BALLOON CATHETER (TERUMO) WAS DELIVERED IN THE LEFT RENAL ARTERY, A 6F SELECON BALLOON CATHETER (TERUMO) IN LEFT RENAL VEIN. A 4F ANGIOGRAPHY CATHETER (GLIDECATH/TERUMO) WAS INDUCED TO SHUNT IN LEFT RENAL VENOUS SAC VIA RIGHT FEMORAL VEIN PUNCTURE. AFTER AN 8 MM AMPLATZER VASCULAR PLUG 4 (AVP4, LOT UNKNOWN) WAS DEPLOYED AT THE ARTERIOVENOUS FISTULA, ADDITIONAL COIL EMBOLIZATION WAS PERFORMED USING 15 MICROCOILS (RUBY COIL/MEDICOS HIRATA AND TORNADE/COOK (B)(4), RESPECTIVE SIZE AND UNIT UNKNOWN). AFTER EMBOLIZATION WITH THE AVP4 AND MICROCOILS, RIGHT RENAL ANGIOGRAPHY WAS PERFORMED. THE RENAL AVF COMPLETELY DISAPPEARED BUT IT REVEALED EXTREMELY SLOW FLOW IN THE LEFT RENAL VEIN SAC, THEN HEPARIN (15,000 IU/DAY) WAS IMMEDIATELY STARTED TO ADMINISTER AFTER REMOVAL OF SHEATH. THE FOLLOWING DAY, THE PATIENT COMPLAINED OF FLANK PAIN ON THE RIGHT SIDE. DOPPLER ULTRASONOGRAPHY (US) WAS PERFORMED. DURING DOPPLER US EXAMINATION, THE PATIENT COMPLAINED OF CHEST PAIN, AND LEVEL OF CONSCIOUSNESS BECAME DECREASED. REPEATED CONTRAST ENHANCED CT WAS PERFORMED AFTER RECOVERY OF CONSCIOUSNESS, AND EXTENSIVE PULMONARY THROMBOEMBOLISM (PTE) AND HUGE THROMBUS IN THE LEFT RENAL VEIN SAC WERE CONFIRMED. AS THE CAUSE OF CHEST PAIN AND LOSS OF CONSCIOUSNESS WAS DEEMED TO BE DUE TO THE PTE, TISSUE-PLASMINOGEN ACTIVATOR (T-PA) WAS INJECTED INTO THE LEFT RENAL VEIN. FURTHERMORE, AN INTERNAL JUGULAR INFERIOR VENA CAVA FILTER CATHETER WAS PLACED IN THE PROXIMITY OF LIVER VIA RIGHT INTERNAL CAROTID VEIN PUNCTURED, WHICH DELIVERED THROUGH A 7F SHEATH. LATER ON, LEFT RENAL VENOUS REEFING WAS PERFORMED BY LAPAROTOMY. THE LEFT RENAL VENOUS SAC WAS SHRUNK TO APPROXIMATELY 2.5 CM IN DIAMETER, HOWEVER THROMBOSIS RECURRED IN THE VENOUS SAC. ADMINISTRATION OF HEPARIN WAS CONTINUED BUT TYPE II HEPARIN-INDUCED THROMBOCYTOPENIA WAS SUBSEQUENTLY DEVELOPED. ANTICOAGULANT WAS THEREFORE CHANGED AND TOTAL LEFT RENAL EXCISION WAS FINALLY PERFORMED BY RELAPAROTOMY. THE PATIENT'S POSTOPERATIVE COURSE WAS REPORTEDLY UNEVENTFUL. ACCORDING TO THE LEAD AUTHOR, MASSIVE THROMBUS IN THE LEFT RENAL VEIN AND PULMONARY THROMBOEMBOLISM WERE ASSUMED TO BE CAUSED BY THE MARKEDLY DILATED VENOUS SAC DUE TO LONG-TERM HIGH FLOW OF RENAL AVF, EXTREMELY DECREASING AND SLOWING OF BLOOD FLOW AFTER EMBOLISATION WITH AVP4 AND MICROCOILS, AND INFLAMMATORY CHANGE ASSOCIATED WITH DEPLOYMENT OF THE AVP4 AND MICROCOILS. IN CASE OF MARKEDLY DILATED RENAL VEIN, CONSIDERATION THAT NEPHRECTOMY SHOULD BE CONTAINED AS INITIAL THERAPEUTIC APPROACH IS REQUIRED. PATIENT SPECIFIC INFORMATION OF PATIENT IDENTIFIER, AGE OR BIRTHDATE AND WEIGHT ARE NOT AVAILABLE FOR THIS COMPLAINT. THE AVP4 WAS EXPLANTED AT THE TIME OF NEPHRECTOMY, HOWEVER THE EXPLANTED DEVICE WAS DISCARDED AT THE HOSPITAL. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    896869 AMPLATZER VASCULAR PLUG 4 ARTERIAL EMBOLIZATION DEVICE KRD AGA MEDICAL CORPORATION 9-AVP038-008

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R