BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT STENT GRAFT

    MDR report key: 21856977 · Received April 17, 2025

    Report

    Report Number
    9612164-2025-01956
    Event Type
    Injury
    Date Received
    April 17, 2025
    Date of Event
    March 3, 2022
    Report Date
    April 17, 2025
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION FROM A JOURNAL ARTICLE ENTITLED; ¿PREDICTORS OF ABDOMINAL AORTIC ANEURYSM SHRINKAGE AFTER ENDOVASCULAR REPAIR¿  VAN RIJSWIJK, R.E.; GROOT JEBBINK, E.; HOLEWIJN, S.; STOOP, N.; VAN STERKENBURG, S.M.; REIJNEN JOURNAL OF CLINICAL MEDICINE  2022, 11, 1394.  HTTPS://DOI.ORG/ 10.3390/JCM11051394. 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  ¿ PREDICTORS OF ABDOMINAL AORTIC ANEURYSM SHRINKAGE AFTER ENDOVASCULAR REPAIR¿.  THE TIME FRAME OF THIS STUDY WAS OVER A SEVEN YEAR PERIOD. MULTIPLE MANUFACTURES PRODUCTS WERE IMPLANTED. ENDURANT STENT GRAFTS WERE IMPLANTED IN THE 174 PATIENT POPULATION. IN THIS STUDY, A RANGE OF PARAMETERS WERE INVESTIGATED TO IDENTIFY THEIR USE IN DIFFERENTIATING PATIENTS THAT WILL DEVELOP A SHRINKING AAA FROM THOSE WITH A STABLE AAA ONE-YEAR AFTER EVAR. THE FOLLOWING ADVERSE EVENTS OCCURRED:  INFECTION, PNEUMONIA, RENAL INSUFFICIENCY , INTERVENTION  PATIENT MORTALITY WAS REPORTED BUT THERE IS NO CAUSAL LINK THAT A MDT STENT GRAFT CAUSED OR CONTRIBUTED TO ANY DEATHS.   NO FURTHER INFORMATION WAS PROVIDED PERTAINING TO MEDTRONIC PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1748177 ENDURANT STENT GRAFT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TR MIH MEDTRONIC IRELAND UNK-CV-SR-ENDURANT

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Male Required Intervention