BEUDAMED
    FDA Adverse Event Death Summary report: N

    VALIANT STENT GRAFT

    MDR report key: 10501806 · Received September 8, 2020

    Report

    Report Number
    9612164-2020-03386
    Event Type
    Death
    Date Received
    September 8, 2020
    Date of Event
    January 3, 2020
    Report Date
    October 26, 2020
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    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

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION FROM A JOURNAL ARTICLE ENTITLED; MINIMALLY INVASIVE REPAIR OF ASCENDING AORTIC PSEUDOANEURYSMS: AN ALTERNATIVE TO OPEN SURGICAL REPAIR IN HIGH-RISK PATIENTS. ZUCKER J.S D , SMITH A, SRINIVASA N R, YANG H E, KWON H K, MORIARTY M J. JOURNAL VASCULAR INTERVENTIONAL RADIOLOGY 2020; 31:1342¿1347 HTTPS://DOI.ORG/10.1016/J.JVIR.2020.01.035. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    A (B)(6) MALE PATIENT WAS IMPLANTED WITH A MODIFIED VALIANT STENT GRAFT IN THE ENDOVASCULAR REPAIR OF A WIDE-NECKED 9.1 X 6.1CM MYCOTIC ASCENDING AORTIC PSEUDOANEURYSM. THE GRAFT WAS MODIFIED TO SIZE USING ELECTROCAUTERY USING PRE-PROCEDURAL CT IMAGING. TO GAIN ADEQUATE SEAL, THE TARGET PROXIMAL LANDING ZONE INCLUDED THE SINOTUBULAR JUNCTION. IT WAS REPORTED THAT FOLLOWING DEPLOYMENT OF THE VALIANT STENT GRAFT WITH SUCCESSFUL EXCLUSION OF THE PSEUDOANEURYSM SAC, THE PATIENT BECAME PULSELESS. DESPITE ATTEMPTS OF CARDIOPULMONARY RESUSCITATION, THE PATIENT EXPIRED ON THE TABLE. AN AUTOPSY PERFORMED SUGGESTED ACUTE AORTIC INSUFFICIENCY, LIKELY DUE TO STRETCHING OF THE AORTIC ANNULUS, AS THE IMMEDIATE CAUSE OF DEATH. NO ADDITIONAL CLINICAL SEQUELAE WERE PROVIDED AND THE PATIENT IS EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    968751 VALIANT STENT GRAFT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND UNK-CV-SR-VALIANT

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Death