BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT BIFURCATED STENT GRAFT

    MDR report key: 10161645 · Received June 17, 2020

    Report

    Report Number
    9612164-2020-02223
    Event Type
    Injury
    Date Received
    June 17, 2020
    Date of Event
    December 19, 2019
    Report Date
    July 13, 2020
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION OBTAINED FROM THE JOURNAL ARTICLE ENTITLED; ANTIBIOTICS AND PERCUTANEOUS DRAINAGE FOR TREATING STENT-GRAFT INFECTION AFTER EVAR FENG ZHU, XIAOHU GE, HONGBO CI, & SHENG GUAN, ANNALS OF VASCULAR SURGERY 2020; 65: 289.E1¿289.E6 HTTPS://DOI.ORG/10.1016/J.AVSG.2019.12.009 . CONCOMITANT MEDICAL PRODUCTS: OTHER RELEVANT DEVICE(S) ARE: ENLW1616C120EE, S/N: UNKNOWN; USE BY DATE: UNKNOWN, UPN # :UNKNOWN; ENLW1616C120EE, S/N: UNKNOWN; USE BY DATE: UNKNOWN, UPN #: UNKNOWN; ENLW1613C120EE, S/N: UNKNOWN; USE BY DATE: UNKNOWN, UPN #: UNKNOWN; ENLW1616C120EE, S/N: UNKNOWN; USE BY DATE: UNKNOWN, UPN #: UNKNOWN. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS UPDATED. OTHER RELEVANT DEVICES ARE: ENLW1610C95EE, S/N : (B)(4) USE BY DATE: 2017-06-09 , UPN # (B)(4); ENLW1616C95EE, S/N: (B)(4); USE BY DATE: 2017-02-02, UPN # (B)(4); ENLW1616C120EE, S/N: (B)(4), USE BY DATE: 2017-12-01, UPN # (B)(4); ENLW1616C120EE S/N: (B)(4), USE BY DATE 2017-10-20: UPN # (B)(4). SUSPECT DEVICE'S INFO AND IMPLANT DATE UPDATED, PT'S WEIGHT UPDATED, MANUFACTURE DATE UPDATED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    AN ENDURANT BIFURCATE STENT GRAFT SYSTEM WAS IMPLANTED IN A (B)(6) PATIENT FOR A 70MM DIAMETER ABDOMINAL AORTIC ANEURYSM ON AN UNKNOWN DATE. IT WAS REPORTED THE AORTIC NECK WAS LONGER THAN 15MM AND THE RIGHT COMMON ILIAC ARTERY WAS ALSO ANEURYSMAL. A (ENBF2816C170EE) WAS INSERTED VIA THE LEFT COMMON FEMORAL ARTERY FOLLOWED BY TWO ENDURANT LIMBS (ENLW1616C120EE) IMPLANTED AT THE LEFT ILIAC ARTERY DISTAL END. ON THE RIGHT SIDE TWO LIMBS, (ENLW1613C120EE) AND (ENLW1616C120EE) WERE SUCCESSFULLY IMPLANTED. POST-OPERATIVE ANGIOGRAM SHOWED COMPLETE CLOSURE OF THE ANEURYSM CAVITY. 3 DAYS FOLLOWING THIS PROCEDURE A SUBCUTANEOUS HEMATOMA AT THE PUNCTURE POINT OF THE RIGHT GROIN AND SWELLING OF THE RIGHT LOWER EXTREMITY WAS DIAGNOSED. THESE SYMPTOMS DID NOT IMPROVE SO AN EMERGENCY RIGHT FEMORAL ARTERY EXPLORATION WAS PERFORMED. THE ENTRY TEAR WAS FOUND AND SUTURED AND THE PROCEDURE COMPLETED. FOLLOWING THIS THE PATIENT HAD INTERMITTENT LOW GRADE FEVERS AND ABNORMAL BLOOD RESULTS INDICATING AN INFECTION. A CT REVEALED SLIGHT EXUDATION IN THE LOWER LEFT LUNG SO PNEUMONIA WAS CONSIDERED. ANTIBIOTICS WERE COMMENCED. THE SYMPTOMS ALL NORMALIZED AND THE PATIENT WAS DISCHARGED. AFTER 20 DAYS, THE PATIENT WAS ADMITTED AGAIN WITH A 10 DAY HISTORY OF LUMBAR AND ABDOMINAL PAIN AND A FEVER. A CT PERFORMED REVEALED RIGHT HYDRONEPHROSIS AND RIGHT GROIN SUBCUTANEOUS SOFT TISSUE INFECTION. AFTER ONE MONTH OF ANTI-INFLAMMATORY TREATMENT, THE PATIENT DID NOT SIGNIFICANTLY IMPROVE. A RE-EXAMINATION WAS PERFORMED AND A CT REVEALED AN ABSCESS OF THE LEFT GREATER PSOAS MUSCLE AND MIXED DENSITY SHADOWS AROUND THE STENT AND BUBBLE SHADOWS. THE BLOOD CULTURES INDICATED AN E COLI INFECTION. IT WAS SUSPECTED TO BE A CASE OF ARTIFICIAL GRAFT INFECTION AFTER EVAR. ARTIFICIAL GRAFT RESECTION AND REVASCULARIZATION WAS THEN PERFORMED TWICE IN SUCCESSION ALONG WITH THE ADMINISTRATION OF ANTIBIOTICS. AFTER ANOTHER 18 MONTHS THE PATIENT WAS ADMITTED AGAIN DUE TO THE INFECTION RE-OCCURRING. PERCUTANEOUS DRAINAGE WAS PERFORMED AGAIN ALONG WITH MEDICATION GIVEN. THE PATIENT THEN IMPROVED AND WAS DISCHARGED. 1 YEAR HAS ELAPSED AND THE PATIENT HAS SHOWN NO MORE SIGNS OF INFECTION. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT CONTINUES TO BE MONITORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    625102 ENDURANT BIFURCATED STENT GRAFT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND ENBF2816C170EE

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization| R