BEUDAMED
    FDA Adverse Event Death Summary report: N

    THORAFLEX HYBRID

    MDR report key: 19030289 · Received April 3, 2024

    Report

    Report Number
    9612515-2020-00021
    Event Type
    Death
    Date Received
    April 3, 2024
    Date of Event
    January 31, 2024
    Report Date
    April 2, 2024
    Manufacturer
    VASCUTEK LTD
    Product Code
    QSK
    UDI-DI
    05037881027067
    PMA / PMN Number
    P210006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURERS NARRATIVE: CLINICAL CODE: 1770 - STROKE/ CVA: AS REPORTED EXTEND STUDY WAS CONFIRMED AS STROKE/CVA ON EVENT INTAKE FORM. IMPACT CODE: 1802 - DEATH: SITE CONFIRMED THAT PATIENT DEATH WAS ON (B)(6) 2024. MEDICAL DEVICE CODE: 2993 - ADVERSE EVENT WITHOUT IDENTIFIED DEVICE OR USE PROBLEM: STROKE ALERT WAS ACTIVATED INTRA-OPERATIVELY, AND SUBJECT WAS FOUND TO HAVE A RIGHT M1 OCCLUSION. COMPONENT CODE: 4755 - PART/COMPONENT/SUB-ASSEMBLY TERM NOT APPLICABLE. TYPE OF INVESTIGATION: 4110 - TREND ANALYSIS: A 5 YEAR REVIEW OF SIMILAR COMPLAINTS (THORAFLEX HYBRID SALES JAN 19 - JAN 24 VS MEDICAL EVENT STROKE JAN 2019 TO MAR 24 COMPLAINTS) GAVE AN OCCURRENCE RATE OF (B)(4) (COMPLAINTS V SALES). 4111 - COMMUNICATION/ INTERVIEW: A/W ADDITIONAL INFORMATION FROM SITE. 3331 - ANALYSIS OF PRODUCTION RECORDS: A REVIEW OF MANUFACTURING AND QC RECORDS CONFIRMED THAT THERE WERE NO ISSUES WITH THE MANUFACTURE OF THE DEVICE. 4114 - DEVICE NOT RETURNED: SITE CONFIRMED ON INTAKE FORM THAT DEVICE WAS NOT AVAILABLE FOR RETURN.

    Description of Event or Problem · 0

    AUTOMATED E-MAIL NOTIFICATION RECEIVED FROM STUDY DATABASE ON 08 FEB 2024 REPORTING THE EVENT OF CVA (STROKE) FROM 31 JAN 24. AT THE TIME OF REPORTING THE "RELATIONSHIP TO DEVICE WAS NOT COMPLETED" HOWEVER AN EMAIL NOTIFICATION WAS RECEIVED ON 15 MAR 2024 WHERE THE "RELATIONSHIP TO DEVICE" HAD BEEN POPULATED AS "POSSIBLY RELATED". # INFORMATION PROVIDED FROM SITE WAS -CTA SHOWED RIGHT M1/M2 OCCLUSION AND CTP SHOWING PERFUSION DEFICIT. THE SUBJECT DIED ON (B)(6) 2024. AN EXPORT OF THE INFORMATION AVAILABLE IN THE STUDY DATABASE FOR THIS SUBJECT TO DATE HAS BEEN PROVIDED SEPARATELY. PATIENT (B)(6) WAS NOTED TO HAVE AN ENDOLEAK AND ON (B)(6) 2024 WENT TO THE OPERATING ROOM WITH DR. (B)(6) ASCENDING AORTIC, TOTAL ARCH REPLACEMENT, AORTIC VALVE RESUSPENSION, FROZEN ELEPHANT TRUNK WITH THORAFLEX GRAFT, CABG X2, LIMA-LAD, SVG-OM, MV REPAIR WITH TRIANGULAR RESECTION OF P2 SEGMENT, PHYSIO II RING, INTRAOPERATIVELY FOUND TO HAVE LOST LEFT SIDED SSEPS CONSISTENT WITH A RT. CORTICAL PROCESS. ON SUBSEQUENT NEUROIMAGING FOUND TO HAVE A RT. M1 OCCLUSION, S/P EVT WITH SMAT X 1 VIA DIRECT CAROTID ACCESS WITH TICI3 REPERFUSION. POST OPERATIVE COURSE COMPLICATED BY HEMORRHAGIC CONVERSION OF CVA WITH SUBSEQUENT CEREBRAL EDEMA AND MIDLINE SHIFT, NEUROSURGERY WAS CONSULTED AND RECOMMEND CRANIECTOMY, BUT FAMILY DECIDED NOT TO PURSUE PROCEDURE. PATIENT HAD WORSENING NEURO EXAM AND SEIZURES, NEUROLOGY WAS CONSULTED WITH CONTINUOUS EEG AND STARTED ON ANTIEPILEPTICS. ON (B)(6), PATIENT HAD WORSENING HEMODYNAMICS WAS STARTED ON INOTROPE AND IABP PLACED, IABP REMOVED ON (B)(6). PATIENT CONTINUE TO HAVE A POOR NEURO EXAM WITH RESPIRATORY FAILURE AND FAMILY MADE THE DECISION TO MAKE PATIENT CMO ON (B)(6) AND PATIENT SHORTLY PASSED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1544657 THORAFLEX HYBRID THORAFLEX HYBRID QSK VASCUTEK LTD N/A 25212951 05037881027067

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male Death