BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDURANT

    MDR report key: 5696496 · Received June 2, 2016

    Report

    Report Number
    2953200-2016-01153
    Event Type
    Death
    Date Received
    June 2, 2016
    Date of Event
    December 1, 2014
    Report Date
    May 12, 2016
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EXACT DATE OF DEATH IS UNKNOWN. EXACT DATE OF EVENT IS UNKNOWN. (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION OBTAINED FROM THE JOURNAL ARTICLE ENTITLED; TYPE B AORTIC DISSECTION WITH ABDOMINAL AORTIC ANEURYSM RUPTURE 1 YEAR AFTER ENDOVASCULAR REPAIR OF ABDOMINAL AORTIC ANEURYSM GUILLAUME DANIEL, SABRINA BEN AHMED, EDOUARD WAREIN, ARNAUD GALLON, AND EUGENIO ROSSET, CLERMONT-FERRAND AND SAINT-ETIENNE, FRANCE (ANN VASC SURG 2016; 33: 229.E7¿229.E10) HTTP://DX.DOI.ORG/10.1016/J.AVSG.2015.11.022 AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 55-MM DIAMETER ABDOMINAL AORTIC ANEURYSM IN NOV-2013. ONE MONTH PRIOR TO THE INDEX PROCEDURE, A RIGHT HYPOGASTRIC EMBOLIZATION WAS PERFORMED SUCCESSFULLY FOR THE MANAGEMENT OF RIGHT COMMON ILIAC ARTERY ANEURYSM WITH A DIAMETER OF 32 MM. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE, THE STENT GRAFT SYSTEM WAS IMPLANTED. A LIMB EXTENSION WAS IMPLANTED FOR THE RIGHT ILIAC ARTERY COVERING THE INTERNAL ILIAC ARTERY PREVIOUSLY EMBOLIZED. THE ANGIOGRAM AT THE END OF THE PROCEDURE WAS SATISFACTORY WITH COMPLETE EXCLUSION OF THE ANEURYSMAL SAC, PATENT ABDOMINAL AORTA, AND ABSENCE OF ENDOLEAKS OR DISSECTION. POSTOPERATIVE CARE WAS UNEVENTFUL, THE PATIENT WAS AMBULATORY AT DAY 1, AND NO PARTICULAR PAIN WAS DEPICTED. BEFORE DISCHARGE, THE PATIENT HAD A DOPPLER ULTRASOUND AND A CONTRAST ENHANCED COMPUTED TOMOGRAPHY (CT) SCAN CONTROL AT DAY 6 THAT DID NOT SHOW ANY ANOMALY. THE PATIENT WAS ASYMPTOMATIC DURING FOLLOW-UP. THE PATIENT HAD A NORMAL CLINICAL EXAMINATION BY A VASCULAR SURGEON AT 3, 6, AND 12 MONTHS AFTER THE PROCEDURE. CONTRAST ENHANCED CT SCANS WERE PERFORMED AT 6 AND 12 MONTHS POSTOPERATIVELY FOLLOWING OUR STANDARD EVAR FOLLOW-UP PROTOCOL. AT THE LAST CONTROL DONE APPROXIMATELY 12 MONTHS AFTER THE INDEX PROCEDURE, THE ANEURYSM REMAINED STABLE IN SIZE AT 55 MM DIAMETER, AND NO ENDOLEAKS WERE DEPICTED. THE DIAMETER AT RENAL LEVEL REMAINED IDENTICAL TO PREVIOUS MEASURES OF 24 MM. THE LOWER THORACIC AORTA HAD A NORMAL APPEARANCE. ONE MONTH AFTER THE 1-YEAR FOLLOW-UP CT SCAN , THE PATIENT WAS ADMITTED TO EMERGENCY DEPARTMENT, 1 HOUR AFTER DEVELOPING SUDDEN ABDOMINAL PAIN ASSOCIATED WITH LEFT LOWER LIMB ISCHEMIA. THERE HAD BEEN NO PREVIOUS CHEST PAIN. THE PATIENT'S BLOOD PRESSURE WAS 120/80 MM HG. AN EMERGENCY CONTRAST-ENHANCED ABDOMINAL CT SCAN WAS PERFORMED. IT SHOWED AN AORTIC DISSECTION WITH THE FALSE LUMEN PERFUSING THE LEFT RENAL ARTERY. THE FALSE LUMEN RUPTURED IN THE ANEURYSM SAC BECAUSE THERE WAS NO RE-ENTRY TEAR TOWARD THE TRUE LUMEN BECAUSE OF THE STENT GRAFT. THE CT SCAN ALSO SHOWED AN ARTERIAL THROMBOSIS OF THE LEFT LOWER LIMB AND A DISCONNECTION BETWEEN THE MAIN BODY GRAFT AND THE RIGHT ILIAC LIMB EXTENSION. WHILE THE CT SCAN WAS BEING DONE, THE PATIENT BECAME UNSTABLE WITH ACUTE ABDOMINAL PAIN. COMPLEMENTARY THORACOABDOMINAL VIEWS WERE OBTAINED IMMEDIATELY TO ASCERTAIN THE ORIGIN OF THE DISSECTION. THE PROXIMAL ENTRY TEAR WAS LOCATED IN THE DESCENDING THORACIC AORTA, 9 MM AFTER THE LEFT SUBCLAVIAN ARTERY. THE ABDOMINAL AORTIC ANEURYSM WAS RUPTURED. THE PATIENT WAS TRANSFERRED DIRECTLY IN THE OPERATING ROOM. AFTER A TRANSPERITONEAL LAPAROTOMY, THE SUPRACELIAC AORTA WAS CLAMPED FOR 30 MINUTES. THE AORTIC SAC WAS OPENED TO REMOVE THE STENT GRAFT. THE AORTIC NECK WAS TRANSECTED AT THE INFRARENAL LEVEL, THE CLAMP WAS REPLACED AT THE INFRARENAL LOCATION, AND A PROXIMAL END-TO-END ANASTOMOSIS WAS DONE. THE REMOVAL OF THE STENT GRAFT INJURED THE ILIAC ARTERIES, AND THEIR HEMOSTASIS WAS DIFFICULT. THE PHYSICIAN CHOSE TO PERFORM AN AORTOBI-FEMORAL INSTEAD OF AN AORTOBI-ILIAC BYPASS TO AVOID THE RISK OF THROMBOSIS. THE THROMBECTOMY OF THE LEFT LOWER LIMB WAS PERFORMED BEFORE COMPLETING THE BYPASS. THE TOTAL LENGTH OF SURGERY WAS 2.5 HOURS. THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT IN UNSTABLE CONDITION NEEDING VASOPRESSIVE SUPPORT. BLOOD LOSS WAS ESTIMATED AT 800 ML. A TOTAL OF 4 UNITS OF PACKED RED CELLS UNITS AND 3 PLATELETS UNITS WERE USED DURING SURGERY. A CT SCAN WAS PERFORMED 5 HOURS POSTOPERATIVELY BECAUSE THE PATIENT WAS IN SHOCK, ACIDOSIS, AND REQUIRED PROGRESSIVELY HIGHER DOSES OF VASOPRESSORS. IT SHOWED NO ABNORMALITY IN THE SURGICAL REPAIR. THE PATIENT DIED AT DAY 4, FROM MULTISYSTEM ORGAN FAILURE. THE CAUSE OF THE ACUTE LEFT LOWER ISCHEMIA WAS PROBABLY AN EMBOLUS FROM THE DISSECTED AORTA. THE PHYSICIAN CHOSE THE RECOMMENDED OVERSIZING OF APPROXIMATELY 15% FROM THE VESSEL INNER DIAMETER. DESPITE THE OVERSIZING, THE RADIAL FORCE OF THE STENT GRAFT WAS NOT SUFFICIENT TO STOP THE DISTAL PROGRESSION OF THE DISSECTION INTO THE SAC. THE FALSE LUMEN INCREASED THE PROXIMAL NECK DIAMETER OF 7 MM FROM THE MEASUREMENTS OF THE PREVIOUS CT SCANS. THE REPERFUSION OF THE ANEURYSMAL SAC OCCURRED WITHOUT COLLA PSE OF THE STENT GRAFT. THIS MECHANISM EXPLAINS THE RUPTURE OF THE ANEURYSM BY INCREASED PRESSURE IN THE SAC WITHOUT OUTFLOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349220 ENDURANT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Death| R