BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDURANT IIS BIFURCATED STENT GRAFT

    MDR report key: 6992651 · Received November 1, 2017

    Report

    Report Number
    2953200-2017-01670
    Event Type
    Death
    Date Received
    November 1, 2017
    Date of Event
    October 6, 2017
    Report Date
    November 1, 2017
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    UDI-DI
    00643169439979
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    OTHER RELEVANT DEVICES ARE: CATALOG NO. ETLW1610C93E ; SERIAL NO. (B)(4); USE BY DATE:26-JUN-2019; UDI # (B)(4); CATALOG NO. ETLW1613C93E ; SERIAL NO. (B)(4); USE BY DATE:23-MAR-2019; UDI # (B)(4); CATALOG NO. ETLW1610C124E ; SERIAL NO. (B)(4); USE BY DATE: 01-JUL-2018; UDI # (B)(4); CATALOG NO. ETLW1610C124E ; SERIAL NO. (B)(4); USE BY DATE:14-AUG-2019; UDI # (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    AN ENDURANT IIS STENT GRAFT SYSTEM WAS IMPLANTED IN THE PATIENT DURING AN EMERGENT ENDOVASCULAR TREATMENT OF A 70 MM IN DIAMETER RUPTURED ABDOMINAL AORTIC ANEURYSM. THE PROXIMAL AORTIC NECK MEASURED APPROXIMATELY 22 MM TO 23 MM IN LENGTH AND THE PATIENT HAD SMALL ILIAC ARTERIES. IT WAS REPORTED THAT, DURING THE PROCEDURE AND AFTER THE ENDURANT II STENT GRAFT SYSTEM WAS SUCCESSFULLY IMPLANTED, AN UNKNOWN ENDOLEAK WAS OBSERVED. CONTRAST INJECTED DISTAL TO THE PROXIMAL SECTION OF THE STENT GRAFT CONFIRMED THAT THE ENDOLEAK WAS NOT A PROXIMAL TYPE I ENDOLEAK. BALLOONING WAS THEN PERFORMED AT THE FLOW DIVIDER BUT THE ENDOLEAK DID NOT RESOLVE. IT WAS SUSPECTED THAT THE ENDOLEAK WAS A TYPE III FABRIC ENDOLEAK OR A POSSIBLE TYPE IV ENDOLEAK. THE PHYSICIAN THEN ELECTED TO RELINE THE LIMBS BILATERALLY AND THE PATIENT APPEARED TO BE STABLE. HOWEVER, THERE WAS STILL AN UNKNOWN ENDOLEAK OBSERVED AT THE END OF THE PROCEDURE AND THE EVENT WAS NOT RESOLVED. IT WAS REPORTED THAT THE PATIENT LATER EXPIRED, ON AN UNKNOWN DATE, DUE TO AN AORTIC RUPTURE. PER THE PHYSICIAN, THE CAUSE OF THE UNKNOWN ENDOLEAK EVENT MAY HAVE BEEN RELATED TO THE DEVICE. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    772996 ENDURANT IIS BIFURCATED STENT GRAFT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND ESBF2814C103E 00643169439979

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Death| R