BEUDAMED
    FDA Adverse Event Death Summary report: N

    AORTIC EXCLUDER AAA ENDOPROSTHESIS (LOW PERM)

    MDR report key: 9213252 · Received October 21, 2019

    Report

    Report Number
    2017233-2019-01052
    Event Type
    Death
    Date Received
    October 21, 2019
    Date of Event
    March 26, 2009
    Report Date
    November 22, 2019
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED: SUSPECT MEDICAL DEVICE. UPDATED: ADVERSE EVENT PROBLEM- METHOD CODE 2, RESULT CODE 1; CONCLUSION CODE 1. ADVERSE EVENT PROBLEM: CODE 213 - THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS. W. L. GORE & ASSOCIATES, INC. (GORE) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY GORE, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. BLANK FIELDS PRESENT ON THIS REPORT INCLUDE REQUIRED FIELDS AND FIELDS DETERMINED TO BE NOT APPLICABLE. BLANK FIELDS INDICATE THAT THE INFORMATION WAS NOT PROVIDED, WAS DEEMED UNAVAILABLE OR WAS NOT APPLICABLE. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, GORE, OR ITS ASSOCIATES THAT THE DEVICE, GORE OR ITS ASSOCIATES 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 REPORT AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA, TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REPORTING PURSUANT TO PART 803. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT.

    Description of Event or Problem · 0

    THE FOLLOWING PUBLICATION WAS REVIEWED: ¿RESULTS OF TRANSARTERIAL EMBOLIZATION FOR TREATING TYPE 2 ENDOLEAKS: A SINGLE CENTER EXPERIENCE¿ (ERNESTO ARENAS AZOFRA ET AL., ANN VASC SURG., PUBLISHED ONLINE 02-AUG-2019). THE ARTICLE DESCRIBES A RETROSPECTIVE ANALYSIS OF A PROSPECTIVELY-MAINTAINED DATABASE CONTAINING 35 CONSECUTIVE PATIENTS TREATED FOR A TYPE 2 ENDOLEAK AFTER ENDOVASCULAR REPAIR OF ABDOMINAL AORTIC ANEURYSMS (EVAR) BETWEEN 2003 AND 2017 IN A SINGLE CENTER. THE ARTICLE PROVIDES DETAILS FOR PATIENT (P2) TREATED WITH GORE® EXCLUDER® AAA ENDOPROSTHESES. ON (B)(6) 2007, THE PATIENT PRESENTED WITH AN 85 MM ABDOMINAL AORTIC ANEURYSM AND WAS TREATED WITH GORE® EXCLUDER® AAA ENDOPROSTHESES. ON (B)(6) 2009, A TYPE II ENDOLEAK ORIGINATING FROM THE LUMBAR ARTERIES WAS IDENTIFIED AND CONSISTENTLY MONITORED. DUE TO SIGNIFICANT ANEURYSM GROWTH TO 96 MM, THE ENDOLEAK WAS TREATED WITH ILIOLUMBAR TRANSARTERIAL EMBOLIZATION ON (B)(6) 2017. ACCORDING TO THE PHYSICIAN THE EMBOLIZATION WAS NOT COMPLETELY SUCCESSFUL AND FURTHER GROWTH WAS VISIBLE. A CONVERSION TO OPEN SURGERY WAS CONSIDERED BUT DUE TO THE HIGH SURGICAL RISK AND OVERALL GENERAL CONDITION OF THE PATIENT NOT PERFORMED. ON (B)(6) 2018, THE PATIENT EXPIRED DUE TO RUPTURE OF THE ANEURYSM SAC (FINAL DIAMETER: 100 MM).

    Additional Manufacturer Narrative · 1

    SINCE NO DATE OF EVENT WAS COMMUNICATED, THE DATE OF ONLINE PUBLICATION WAS USED AS THE EVENT DATE. LOT/SERIAL NUMBERS WERE NOT PROVIDED, THEREFORE, A REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE CONDUCTED.

    Description of Event or Problem · 1

    THE FOLLOWING PUBLICATION WAS REVIEWED: ¿RESULTS OF TRANSARTERIAL EMBOLIZATION FOR TREATING TYPE 2 ENDOLEAKS: A SINGLE CENTER EXPERIENCE¿ (ERNESTO ARENAS AZOFRA ET AL., ANN VASC SURG., PUBLISHED ONLINE 02-AUG-2019). THE ARTICLE DESCRIBES A RETROSPECTIVE ANALYSIS OF A PROSPECTIVELY-MAINTAINED DATABASE CONTAINING 35 CONSECUTIVE PATIENTS TREATED FOR A TYPE 2 ENDOLEAK AFTER ENDOVASCULAR REPAIR OF ABDOMINAL AORTIC ANEURYSMS (EVAR) BETWEEN 2003 AND 2017 IN A SINGLE CENTER. THE ARTICLE PROVIDES DETAILS FOR PATIENT P2, TREATED WITH GORE® EXCLUDER® AAA ENDOPROSTHESES IN 2007, WHO EXPERIENCED ANEURYSM-RELATED DEATH AFTER A TREATED TYPE 2 ENDOLEAK: PRE-EVAR AORTIC DIAMETER: 85 MM, REINTERVENTION AFTER 111.1 MONTHS / PRE-REOPERATION DIAMETER: 96 MM, RUPTURE AFTER 125.4 MONTHS, FINAL DIAMETER: 100 MM, AAA RELATED DEATH AFTER 125.4 MONTHS. NO ADDITIONAL DETAILS ARE PROVIDED IN THE ARTICLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1007900 AORTIC EXCLUDER AAA ENDOPROSTHESIS (LOW PERM) SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES 04614120

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Death