BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT II STENT GRAFT

    MDR report key: 20877361 · Received December 9, 2024

    Report

    Report Number
    9612164-2024-05857
    Event Type
    Injury
    Date Received
    December 9, 2024
    Date of Event
    July 4, 2022
    Report Date
    December 9, 2024
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION FROM A JOURNAL ARTICLE ENTITLED; ¿FAST-TRACK MANAGEMENT OF CONCURRENT PERCUTANEOUS CORONARY INTERVENTION IN PATIENTS SCHEDULED FOR ENDOVASCULAR ABDOMINAL AORTIC ANEURYSM REPAIR¿. WENG C, WANG J, ZHAO J, MA Y, HUANG B, YANG Y, YUAN D, WANG T, CHEN X. JOURNAL OF ENDOVASCULAR THERAPY. 2023 DEC;30(6):892-903. DOI: 10.1177/15266028221105179. 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 ¿ FAST-TRACK MANAGEMENT OF CONCURRENT PERCUTANEOUS CORONARY INTERVENTION IN PATIENTS SCHEDULED FOR ENDOVASCULAR ABDOMINAL AORTIC ANEURYSM REPAIR¿. THE AIM OF THE STUDY WAS TO INVESTIGATE THE SAFETY AND EFFICACY OF FAST-TRACK MANAGEMENT OF CONCURRENT PERCUTANEOUS CORONARY INTERVENTION (PCI) IN PATIENTS WITH ABDOMINAL AORTIC ANEURYSM SCHEDULED FOR ENDOVASCULAR AORTIC ANEURYSM REPAIR (EVAR).ENDURANT II STENT GRAFTS WERE IMPLANTED DURING THE EVAR PROCEDURES. 669 PATIENTS WERE INCLUDED IN THE STUDY. PATIENTS INCLUDED IN THE STUDY WHO UNDERWENT PERCUTANEOUS CORONARY INTERVENTION WITHIN 1 MONTH BEFORE EVAR WERE GROUPED INTO THE FAST-TRACK GROUP, AND THOSE WITHOUT EVIDENCE OF SIGNIFICANT CORONARY ARTERY DISEASE WERE GROUPED INTO THE STANDARD CONTROL GROUP THE FOLLOWING ADVERSE EVENTS WERE REPORTED, HEMORRHAGE, MYOCARDIAL INFARCTION, CARDIAC ARREST, PULMONARY COMPLICATION, INFECTION, IN TERVENTION PATIENT MORTALITY WAS REPORTED BUT THERE IS NO CAUSAL LINK THAT A ENDURANT STENT GRAFT CAUSED OR CONTRIBUTED TO A DEATH OR THAT A DEATH WAS AS A RESULT OF A DETERIORATION IN THE PERFORMANCE CHARACTERISTICS OF A MEDTRONIC DEVICE. NO FURTHER INFORMATION WAS PROVIDED PERTAINING TO MEDTRONIC PRODUCTS

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    107256 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 71 YR Male Other| R