BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT II EXTENSION CUFF

    MDR report key: 22209557 · Received June 16, 2025

    Report

    Report Number
    9612164-2025-02934
    Event Type
    Injury
    Date Received
    June 16, 2025
    Date of Event
    February 25, 2025
    Report Date
    June 16, 2025
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: SECTION D INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: ETLW1616C82E. MEDTRONIC RECEIVED THE FOLLOWING INFORMATION FROM A JOURNAL ARTICLE ENTITLED; ¿ AORTOENTERIC FISTULA FOLLOWING ELECTIVE LAPAROSCOPIC CHOLECYSTECTOMY¿ TUPPER- RING L, MILLS L, MCDONALD J, LIGHTFOOT C, LIVINGSTONE S, JESSULA S J VASC SURG CASES INNOV TECH 2025;11:101761. HTTPS://DOI.ORG/10.1016/J.JVSCIT.2025.101761. 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

    LITERATURE WAS REVIEWED REGARDING ¿AORTOENTERIC FISTULA FOLLOWING ELECTIVE LAPAROSCOPIC CHOLECYSTECTOMY¿ A PATIENT UNDERWENT A LAPAROSCOPIC CHOLECYSTECTOMY. A 12-MM TROCAR WAS PLACED IN THE EPIGASTRIC REGION USING THE OPEN HASSON TECHNIQUE UNDER DIRECT VISUALIZATION, AND TWO 5-MM PORTS WERE INSERTED IN THE RIGHT UPPER QUADRANT. TWENTY-ONE DAYS AFTER THE CHOLECYSTECTOMY, THE PATIENT PRESENTED WITH PERSISTENT ABDOMINAL PAIN. A CTA DEMONSTRATED A PSEUDOANEURYSM OF THE INFRARENAL AORTA OF UNKNOWN ETIOLOGY. AT THE TIME, IATROGENIC AORTIC INJURY SECONDARY TO TROCAR INSERTION WAS PRESUMED. INTERVENTION WAS PERFORMED AN A 20 X 20 X 82 MM MEDTRONIC ENDURANT II ENDOGRAFT LIMB WAS DEPLOYED IN THE INFRARENAL AORTA FOLLOWED BY AN EXTENSION WITH A 16 X 16 X82MM LIMB. ALTHOUGH A LARGER DIAMETER WAS PREFERRED, 16 MM WAS CHOSEN OWING TO THE AVAILABILITY OF ENDOGRAFTS. AFTER BALLOONING OF THE PROXIMAL, DISTAL, AND OVERLAP ZONES OF THE ENDOGRAFTS, A COMPLETION CTA CONFIRMED SATISFACTORY POSITIONING OF THE ENDOGRAFT WITH NO FURTHER EXTRAVASATION OF CONTRAST. IN THE FOLLOWING WEEKS, THE PATIENT PRESENTED MULTIPLE TIMES WITH FATIGUE, EPIGASTRIC PAIN, AND RECURRENT EPISODES OF MELENA. THE PATIENT UNDERWENT SEVERAL UPPER ENDOSCOPIES AND COLONOSCOPIES, ALL OF WHICH WERE UNREMARKABLE; HOWEVER, THE PATIENT CONTINUED TO EXPERIENCE SYMPTOMS CONSISTENT WITH GASTROINTESTINAL BLEEDING. AN ESOPHAGOGASTRODUODENOSCOPY PERFORMED ON POSTOPERATIVE DAY 76 REVEALED A DEFECT IN THE THIRD PORTION OF THE DUODENUM (D3) WITH A PULSATING VESSEL BENEATH IT. THE VISUALIZATION OF WHITE MATERIAL SUGGESTED A CONNECTION TO THE ENDOGRAFT. ALTHOUGH NO DIRECT COMMUNICATION WAS IDENTIFIED ON CT SCAN, SMALL POCKETS OF GAS AND SOFT TISSUE CHANGES SURROUNDING D3 AND ENDOGRAFT, AND SURROUNDING FLUID COLLECTION RAISED CONCERN FOR AN AEF. ADDITIONALLY, THE AORTA AT THE DISTAL EXTENT OF THE ENDOGRAFT DISPLAYED SACCULAR IRREGULARITIES, SUGGESTIVE OF A MYCOTIC ANEURYSM. A MIDLINE LAPAROTOMY WAS PERFORMED, REVEALING SIGNIFICANT BULGING FROM THE RETROPERITONEUM. EXTENSIVE SCARRING AND ADHESIONS WERE OBSERVED BETWEEN THE DUODENUM AND INFRARENAL AORTA. THE AORTIC SAC WAS ENTERED, AND THE BILE-STAINED ENDOGRAFT REMOVED. AN 8-MM DEFECT WAS IDENTIFIED IN THE ANTERIOR AORTIC WALL, WITH BOWEL MUCOSA ABUTTING IT. THE AORTA AND PERIAORTIC TISSUES WERE RESECTED AND DEBRIDED UNTIL CLEAN; SEWABLE EDGES WERE EVIDENT. A BOVINE CONDUIT WAS ANASTOMOSED IN AN END-TO END FASHION FROM THE INFRARENAL AORTA TO THE AORTIC BIFURCATION. A DUODENAL RESECTION OF D3 WAS PERFORMED, ALONG WITH COMMON BILE DUCT EXPLORATION, CHOLANGIOGRAM, AND A SIDE-TO-SIDE DUODENOJEJUNAL ANASTOMOSIS ENSURING A LARGE ANASTOMOSIS USING WELL PERFUSED BOWEL AWAY FROM THE AORTIC RECONSTRUCTION. THE PATIENT EXPERIENCED A PROLONGED RECOVERY, REQUIRING MULTIPLE PERCUTANEOUS DRAINAGES OF ABDOMINAL COLLECTIONS AND AN UNEXPECTED SEIZURE NECESSITATING ADMISSION TO INTENSIVE CARE. MICROBIOLOGY CULTURES OF THE INFECTED ENDOGRAFT REVEALED GROWTH OF ENTEROCOCCUS FAECIUM, GRANULICATELLA ADIACENS, STREPTOCOCCUS ANGINOSUS, STREPTOCOCCUS AGALACTIAE, ESCHERICHIA COLI, AND CANDIDA ALBICANS. THE PATIENT WAS DISCHARGED HOME ON POSTOPERATIVE DAY 101. IT WAS SAID THE UNDIAGNOSED AEF, WHICH WAS LIKELY PRESENT SINCE THE CHOLECYSTECTOMY, SEEDED THE HEMATOGENOUS INFECTION OF THE INITIAL ENDOGRAFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1009292 ENDURANT II EXTENSION CUFF SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TR MIH MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other| R