BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT STENT GRAFT

    MDR report key: 18933689 · Received March 19, 2024

    Report

    Report Number
    9612164-2024-01266
    Event Type
    Injury
    Date Received
    March 19, 2024
    Date of Event
    October 5, 2022
    Report Date
    March 19, 2024
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION OBTAINED FROM THE JOURNAL ARTICLE ENTITLED: REFERRAL CENTRE EXPERIENCE WITH INFECTED ABDOMINAL AORTIC ENDOGRAFT EXPLANTATION KHALID ET AL, EUR J VASC ENDOVASC SURG (2023) 65, 149E158  HTTPS://DOI.ORG/10.1016/J.EJVS.2022.10.003 A2: MEAN AGE A3: MEAN GENDER D6A: EXACT DATE OF IMPLANT UNKNOWN G2: CITATION: AUTHORS: WAJIH KHALID,MATHILDE PUGES, KATHERINE STENSON, CHARLES CAZANAVE, ERIC DUCASSE, CAROLINE CARADU, XAVIER BERARD. REFERRAL CENTRE EXPERIENCE WITH INFECTED ABDOMINAL AORTIC ENDOGRAFT EXPLANTATION. EUROPEAN JOURNAL OF VASCULAR AND ENDOVASCULAR SURGERY VOLUME 65, ISSUE 1, P149-158 2023. HTTPS://DOI.ORG/10.1016/J.EJVS.2022.10.0 EARLIEST DATE OF PUBLICATION USED FOR DATE OF EVENT NO UNIQUE DEVICE IDENTIFIER (SERIAL/LOT) NUMBERS WERE PROVIDED; WITHOUT THIS INFORMATION IT COULD NOT BE DETERMINED WHETHER THESE OBSERVATIONS HAVE BEEN PREVIOUSLY REPORTED. WITHOUT RETURN OF THE PRODUCT NO DEFINITIVE CONCLUSION CAN BE MADE REGARDING THE CLINICAL OBSERVATIONS. 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

    ENDURANT STENT GRAFTS WERE IMPLANTED ON UNKNOWN DATES. SUBSEQUENT EXPLANTS OF ENDURANT AND NON- MDT STENTS WAS COMPLETED DUE TO ENDOGRAFT INFECTIONS. THE FOLLOWING ADVERSE EVENTS WERE REPORTED: INFECTED ENDOGRAFT,  EXPLANT, RUPTURE, AORTO-ENTERIC FISTULAE, VASCULAR HAEMORRHAGE, LOWER LIMB ISCHAEMIA,  RENAL ARTERY OCCLUSION, PERI-GRAFT COLLECTION, PSEUDOANEURYSM,  GASTROINTESTINAL MESENTERIC ISCHAEMIA, CHOLECYSTITIS,  GASTROINTESTINAL BLEEDING, GASTROINTESTINAL TRACT LEAK, FASCIAL DISRUPTION, DELAYED WOUND HEALING, ABDOMINAL COMPARTMENT SYNDROME, HEPATIC ENCEPHALOPATHY,  RENAL AKI, URINARY TRACT INFECTION,  HYDRONEPHROSIS,  HOSPITAL ACQUIRED PNEUMONIA, DELIRIUM. PATIENT DEATH WAS REPORTED. WITHIN 30 DAYS, 90 DAY AND ONE YEAR FOLLOW UP. THERE WAS NO INFORMATION TO SUGGEST ANY MEDTRONIC DEVICE FAILURE CAUSED OR CONTRIBUTED TO A DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2276634 ENDURANT STENT GRAFT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TR MIH MEDTRONIC IRELAND UNK-CV-SR-ENDURANT

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Male Required Intervention SEE H11...