BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDURANT

    MDR report key: 3140372 · Received May 31, 2013

    Report

    Report Number
    2953200-2013-01046
    Event Type
    Death
    Date Received
    May 31, 2013
    Report Date
    May 6, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EXACT DATE OF DEATH IS UNKNOWN. (B)(4), RESULTS: INHERENT RISK OF PROCEDURE (RENAL COMPLICATIONS, DEATH), (INSUFFICIENT INFORMATION; CAUSE IS UNKNOWN), PATIENT¿S CONDITION AFFECTED EFFECTIVENESS OF DEVICE (PRE-EXISTING RENAL INSUFFICIENCY), CONCLUSION: KNOWN INHERENT RISK OF A PROCEDURE (RENAL COMPLICATIONS, DEATH), (INSUFFICIENT INFORMATION; CAUSE IS UNKNOWN), DEVICE FAILURE/LACK OF EFFECTIVENESS RELATED TO PATIENT CONDITION (PRE-EXISTING RENAL INSUFFICIENCY).

    Description of Event or Problem · 1

    AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 79 MM DIAMETER ABDOMINAL AORTIC ANEURYSM APPROXIMATELY THREE MONTHS AGO. VESSEL MORPHOLOGY WAS ADEQUATE. A TYPE II B ENDOLEAK WAS NOTED AND IT WAS CORRECTED BY REMODELING THE STENT GRAFT. THE PATIENT ALREADY SUFFERS RENAL INSUFFICIENCY HAD AN INCREASE IN CREATININE LEVEL (FROM 1.3 FIVE DAYS PRE-IMPLANT TO 1.8MG/DL) AND WAS DIAGNOSED WITH ACUTE CHRONIC RENAL FAILURE. THIS WAS LIKELY AN ACUTE TUBULAR NECROSIS PROCESS GIVEN THE PATIENT¿S PERIOPERATIVE HYPOTENSION, BUT COULD ALSO BE A PRE-RENAL PROCESS GIVEN THE PATIENT¿S BLOOD LOSS (25CC). THE INVESTIGATOR STATES THE RENAL FAILURE WAS RELATED TO THE PROCEDURE, BUT NOT RELATED TO THE STUDY DEVICE. TWO DAYS POST-OPERATIVELY ON THE PATIENT¿S HEMATOCRIT WAS NOTED TO HAVE DRIFTED TO 22%; AND WAS TRANSFUSED WITH 2 UNITS OF PACKED RED BLOOD CELLS. THE INVESTIGATOR STATES THAT THE LOW HEMATOCRIT/HEMOGLOBIN WAS RELATED TO THE PROCEDURE, BUT NOT RELATED TO THE STUDY DEVICE. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED. IT WAS REPORTED THAT THE PATIENT WAS LOST TO FOLLOW UP FOR THEIR 12 MONTH VISIT. ON AN UNKNOWN DATE THE PATIENT EXPIRED. THE DATE OF DEATH IS UNKNOWN. AUTOPSY AND DEATH REPORT ARE NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    241551 ENDURANT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V01014264

    Patients

    Seq Age Sex Outcome Treatment
    1 00084 YR Death