BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT II STENT GRAFT

    MDR report key: 23656912 · Received November 26, 2025

    Report

    Report Number
    9612164-2025-05866
    Event Type
    Injury
    Date Received
    November 26, 2025
    Date of Event
    October 15, 2025
    Report Date
    November 26, 2025
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION FROM A JOURNAL ARTICLE ENTITLED: ¿ A CASE REPORT OF ACUTE HEMOLYSIS AFTER ENDOVASCULAR ABDOMINAL ANEURYSM REPAIR WITH ONYX EMBOLIZATION OF ENDOLEAK: A CLINICAL CONUNDRUM¿  CHOUDHURY A R, VALAKKADA J, AYAPPAN A, ALEX A JOURNAL OF CLINICAL INTERVENTIONAL RADIOLOGY HTTPS://DOI.ORG/10.1055/S-0045-1812286 DATE OF PUBLISH USED FOR INCIDENT DATE IN SECTION 2.3. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION FROM A JOURNAL ARTICLE ENTITLED ¿ A CASE REPORT OF ACUTE HEMOLYSIS AFTER ENDOVASCULAR ABDOMINAL ANEURYSM REPAIR WITH ONYX EMBOLIZATION OF ENDOLEAK: A CLINICAL CONUNDRUM¿ A PATIENT WAS DIAGNOSED WITH A 75MM FUSIFORM ABDOMINAL AORTIC ANEURYSM. THE ANEURYSM SAC WAS LOCATED 20 MM FROM THE LOWEST RENAL ARTERY (RIGHT RENAL ARTERY). ADDITIONALLY, THERE WAS A SMALL CONTRAST-FILLED OUT-POUCHING SUGGESTIVE OF A PENETRATING ATHEROSCLEROTIC ULCER (PAU) AT THE NECK OF THE ANEURYSM. INTERVENTION WAS PERFORMED AND AN ENDURANT IIS STENT GRAFT SYSTEM WAS IMPLANTED. POST-DEPLOYMENT ANGIOGRAPHY REVEALED ONGOING FILLING OF THE SAC (IA ENDOLEAK) AND PROXIMAL PAU, LIKELY ATTRIBUTED TO INADEQUATE APPOSITION AT THE PROXIMAL LANDING ZONE. THEREFORE THE PAU WAS EMBOLIZED WITH COILS AND AN EMBOLIC AGENT WAS USED IN THE ANEURYSM SAC. THE FINAL ANGIOGRAM INDICATED NO FURTHER ENDOLEAK. OVERALL, THE INTRA-PROCEDURAL BLOOD LOSS WAS LESS THAN 100 ML. ON THE MORNING OF POSTOPERATIVE DAY (POD) 1, THE PATIENT EXHIBITED A SIGNIFICANT DECREASE IN HEMOGLOBIN (HB) LEVELS, DROPPING FROM 11.9 TO 9.1 G/DL. THE PATIENT REMAINED ASYMPTOMATIC AND HEMODYNAMICALLY STABLE, MAINTAINING A BLOOD PRESSURE OF 100/70 MM HG. IMAGING OF THE PATIENTS ABDOMEN CONFIRMED NO ISSUES AND NO RETROPERITONEAL FREE FLUID. HOWEVER BY THAT AFTERNOON THE PATIENTS HB HAD DROPPED TO 8.5G/DL. A CT CONFIRMED NO BLEEDING OR ENDOLEAK. THE PATIENT WAS TRANSFUSED WITH 2 UNITS OF RED BLOOD CELLS. ANOTHER DROP IN HB LEVELS WAS NOTED THE FOLLOWING MORNING ON POST -OP DAY 2 HOWEVER THE PATIENTS HEMOGLOBIN LEVELS STABILISED ON DAY 3 AND NO FURTHER TRANSFUSION WAS REQUIRED. LABORATORY INVESTIGATIONS INDICATED A SIGNIFICANT INCREASE IN INDIRECT BILIRUBIN, RISING FROM A PREPROCEDURAL VALUE OF 0.5 MG/DL TO A POST-PROCEDURAL VALUE OF 1.2 MG/DL, ACCOMPANIED BY AN ISOLATED ELEVATION OF SERUM GLUTAMIC-OXALOACETIC TRANSAMINASE LEVELS. THE POST-PROCEDURE RETICULOCYTE COUNT WAS RECORDED AT 2.5% (ELEVATED) AND AN INCREASED SERUM LACTATE LEVEL,WHICH COLLECTIVELY SUGGESTED ACUTE HEMOLYSIS. THE PATIENT WAS OBSERVED FOR AN ADDITIONAL 2 DAYS AND WAS ULTIMATELY DISCHARGED IN STABLE CONDITION ON POD 5. IT WAS SAID THAT ONE POSSIBLE CAUSE OF THE HEMOLYSIS COULD BE MECHANICAL DAMAGE TO THE RED BLOOD CELLS BY THE BARE METAL PART OF THE STENT AND THE TORTUOSITY OF THE ILIAC VESSELS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1946620 ENDURANT II STENT GRAFT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TR MIH MEDTRONIC IRELAND UNK-CV-SR-ENDUR-II

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Male Required Intervention