BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDURANT STENT GRAFT

    MDR report key: 20451620 · Received October 15, 2024

    Report

    Report Number
    9612164-2024-04707
    Event Type
    Malfunction
    Date Received
    October 15, 2024
    Date of Event
    March 19, 2024
    Report Date
    October 15, 2024
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

     MEDTRONIC RECEIVED THE FOLLOWING INFORMATION FROM A JOURNAL ARTICLE ENTITLED; ¿SIDE BRANCH EMBOLIZATION BEFORE ENDOVASCULAR ABDOMINAL AORTIC ANEURYSM REPAIR TO PREVENT TYPE II ENDOLEAK: A PROSPECTIVE MULTICENTER STUDY". TOMOYUKI GENTSU, MASATO YAMAGUCHI, KOJI SASAKI, RYOTA KAWASAKI, HIROKI HORINOUCHI, TETSUYA FUKUDA, NAOKAZU MIYAMOTO, TAKEKI MORI, NORIAKI SAKAMOTO, KENSUKE UOTANI, TAKANORI TANIGUCHI, YOJIRO KODA, KATSUHIRO YAMANAKA, HIROAKI TAKAHASHI, KENJI OKADA, TARO HAYASHI, TOSHITAKA WATANABE, YOSHIKATSU NOMURA, KEIGO MATSUSHIRO, EISUKE UESHIMA, TAKUYA OKADA, KOJI SUGIMOTO, TAKAMICHI MURAKAMI. DIAGNOSTIC AND INTERVENTIONAL IMAGING 105 (2024) 326-335 HTTPS://DOI.ORG/10.1016/J.DIII.2024.03.003 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. 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 ¿ SIDE BRANCH EMBOLIZATION BEFORE ENDOVASCULAR ABDOMINAL AORTIC ANEURYSM REPAIR TO PREVENT TYPE II ENDOLEAK: A PROSPECTIVE MULTICENTER STUDY". THE TIME FRAME OF THIS STUDY WAS OVER A THREE YEAR PERIOD . 100 PATIENTS WERE INCLUDED IN THE STUDY AND ALL PATIENTS WERE IMPLANTED WITH A ENDURANT STENT GRAFT FOR THE ENDOVASCULAR TREATMENT OF ABDOMINAL AORTIC ANEURYSMS. THE MEAN ANEURYSM SAC DIAMETER WAS 50.9 +/- 6.2MM.  THE AIM OF THE STUDY WAS TO EVALUATE THE EFFICACY AND SAFETY OF PRE-EMPTIVE TRANSCATHETER ARTERIAL EMBOLIZATION (P-TAE) OF AORTIC SIDE BRANCHES TO PREVENT TYPE II ENDOLEAK (T2EL). AMONG THE PATIENT POPULATION THE FOLLOWING MALFUNCTIONS OCCURRED: STENT GRAFT KINKING  THE FOLLOWING INJURIES WERE REPORTED; MYOCARDIAL INFRACTION, PNEUMONIA, CEREBRAL INFRACTION, ACUTE KIDNEY INJURY, INFECTION, PSEUDOANEURYSM, INTERVENTION  PATIENT MORTALITY WAS REPORTED BUT THERE IS NO CAUSAL LINK THAT A ENDURANT  STENT GRAFT CAUSED OR CONTRIBUTED TO ANY DEATH OR ANY DEATH WAS AS A RESULT OF A MALFUNCTION OF THE ENDURANT STENT GRAFT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36035 ENDURANT STENT GRAFT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TR MIH MEDTRONIC IRELAND UNK-CV-SR-ENDURANT

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown