BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VALIANT STENT GRAFT

    MDR report key: 8944694 · Received August 29, 2019

    Report

    Report Number
    9612164-2019-03646
    Event Type
    Injury
    Date Received
    August 29, 2019
    Date of Event
    January 31, 2018
    Report Date
    August 29, 2019
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION OBTAINED FROM THE JOURNAL ARTICLE ENTITLED; TOTAL ARCH REPLACEMENT VERSUS DEBRANCHING THORACIC ENDOVASCULAR AORTIC REPAIR FOR AORTIC ARCH ANEURYSM: WHAT INDICATES A HIGH-RISK PATIENT FOR ARCH REPAIR IN OCTOGENARIANS? YOSHIMASA SEIKE, HITOSHI MATSUDA, TETSUYA FUKUDA, YOSUKE INOUE, ATSUSHI OMURA, KYOKUN UEHARA, HIROAKI SASAKI, JUNJIRO KOBAYASHI GENERAL THORACIC AND CARDIOVASCULAR SURGERY (2018) 66:263¿269. DOI: HTTPS://DOI.ORG/10.1007/S11748-018-0894-1. DEATHS ARE COMMON OCCURRENCES IN CLINICAL STUDIES, HOWEVER THE CAUSE(S) OF DEATH ARE OFTEN NOT CHARACTERIZED OR CLEARLY ASSOCIATED WITH A PARTICULAR PRODUCT. THIS IS THE CASE FOR THE DEATHS NOTED IN THIS JOURNAL ARTICLE WITH NO MEDTRONIC DEVICES NOTED AS A CONTRIBUTORY CAUSE IN THE DEATHS OF THE PATIENTS. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    VALIANT STENT GRAFT SYSTEMS WERE IMPLANTED IN A PATIENT GROUP FOR THORACIC ENDOVASCULAR AORTIC ANEURYSM REPAIR. THE FOLLOWING ADVERSE EVENTS WERE OBSERVED IN THE TEVAR PATIENT GROUP: PNEUMONIA PARAPLEGIA PARAPALSIS ACUTE TYPE A AORTIC DISSECTION PERIOPERATIVE STROKE AORTIC ANEURYSM RUPTURE MALIGNANT TUMOR INTESTINAL BLEEDING ILEUS EARLY DEATH (DUE TO PNEUMONIA) LATE DEATH (CAUSES: PNEUMONIA, AORTIC ANEURYSM RUPTURE, CEREBRAL INFARCTION, MALIGNANT TUMOR, ACUTE TYPE A AORTIC DISSECTION, INTESTINAL BLEEDING, ILEUS).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    741236 VALIANT STENT GRAFT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND UNK-CV-SR-VALIANT

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Other| S