BEUDAMED
    FDA Adverse Event Death Summary report: N

    VALIANT CAPTIVIA - FF

    MDR report key: 12415333 · Received September 2, 2021

    Report

    Report Number
    9612164-2021-03406
    Event Type
    Death
    Date Received
    September 2, 2021
    Date of Event
    August 18, 2021
    Report Date
    February 1, 2022
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100040
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT ANALYSIS CONCLUSION; THE STENT GRAFT VAMF4238C150TE RETURNED WITH MULTIPLE ABRASION HOLES AT STENT RING 3 AND 4. MULTIPLE SUTURE BREAKS WERE PRESENT ALONG THE LENGTH OF THE STENT GRAFT AT STENT RINGS 1, 2, 4, 5 ,6 AND 7. A BEND WAS OBSERVED TO THE SUPPORT STENT BETWEEN THE PROXIMAL END OF THE STENT GRAFT AND STENT RING 1. NO NITINOL BREAKS WERE PRESENT. NO OTHER DAMAGE OR DEFORMATION WAS EVIDENT TO THE STENT GRAFT. THE REPORTED ¿NO KNOWN DEVICE PROBLEM¿ CANNOT BE CONFIRMED THROUGH ANALYSIS. CALIPERS CAL # 1233245 RULER CAL # 801163. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED 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. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    A VALIANT CAPTIVIA STENT GRAFT WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A 38 MM THORACIC AORTIC ANEURYSM. IT WAS REPORTED THAT THE PATIENT PRESENTED EMERGENTLY TO THE HOSPITAL APPROXIMATELY 3 MONTHS POST INDEX PROCEDURE, WHERE AORTOESOPHAGEAL FISTULA WAS OBSERVED. THE ENDOPROSTHESIS WERE EXPLANTED ON THE SAME DAY, BUT THE PATIENT DIED DUE TO HEMORRHAGE. AS PER THE PHYSICIAN, CAUSE OF THE EVENT WAS DUE TO PATIENT'S ANATOMY. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1315492 VALIANT CAPTIVIA - FF SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TR MIH MEDTRONIC IRELAND VAMF4238C150TE

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Female Required Intervention| D