BEUDAMED
    FDA Adverse Event Death Summary report: N

    RELAY PRO NBS THORACIC STENT-GRAFT SYSTEM

    MDR report key: 19607770 · Received June 25, 2024

    Report

    Report Number
    2247858-2024-00144
    Event Type
    Death
    Date Received
    June 25, 2024
    Date of Event
    May 8, 2024
    Report Date
    August 13, 2024
    Manufacturer
    BOLTON MEDICAL, INC.
    Product Code
    MIH
    PMA / PMN Number
    P200045
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    BOLTON MEDICAL, INC. (D/B/A TERUMO AORTIC), HEREIN KNOWN AS THE "COMPANY", IS SUBMITTING THIS REPORT PURSUANT TO 21 CFR PART 803, HAS MADE REASONABLE EFFORTS TO OBTAIN COMPLETE INFORMATION, AND HAS PROVIDED AS MUCH AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT IS BASED ON INFORMATION OBTAINED BY THE COMPANY, WHICH MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE REGULATIONS. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN, UNAVAILABLE, OR NOT APPLICABLE. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY ANYONE THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE A LEGAL ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY DEFECTS OR HAS MALFUNCTIONED, AS DEFINED FROM A LEGAL STANDPOINT. THESE WORDS ARE INCLUDED IN THE REPORT AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE CERTAIN REGULATIONS, 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.

    Additional Manufacturer Narrative · 0

    BOLTON MEDICAL, INC. (D/B/A TERUMO AORTIC), HEREIN KNOWN AS THE "COMPANY", IS SUBMITTING THIS REPORT PURSUANT TO 21 CFR PART 803, HAS MADE REASONABLE EFFORTS TO OBTAIN COMPLETE INFORMATION, AND HAS PROVIDED AS MUCH AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT IS BASED ON INFORMATION OBTAINED BY THE COMPANY, WHICH MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE REGULATIONS. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN, UNAVAILABLE, OR NOT APPLICABLE. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY ANYONE THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE A LEGAL ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY DEFECTS OR HAS MALFUNCTIONED, AS DEFINED FROM A LEGAL STANDPOINT. THESE WORDS ARE INCLUDED IN THE REPORT AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE CERTAIN REGULATIONS, 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

    "SITE WAS INFORMED TODAY 29 MAY 2024 THAT THE SUBJECT UNFORTUNATELY PASSED AWAY (B)(6) 2024. SITE HAS LOOKED THROUGH PATIENT'S RECORDS AND ARE UNABLE TO LOCATE ANYTHING IN REGARDS TO ANY HOSPITALIZATIONS, ETC. WILL FOLLOW-UP WITH MORE INFORMATION AS SOON AS IT IS PROVIDED BY THE SITE. ADDITIONAL INFORMATION RECEIVED FROM THE SITE ON 05/30/2024: - (B)(6) - 7 TEETH PULLED AT DENTIST; PROCEDURE WENT WELL AND PATIENT CAME HOME. - (B)(6) - WAS FOUND DECEASED ON THE COUCH AT HIS UNCLE'S HOUSE. OVER THE PAST FEW WEEKS PRIOR TO PATIENT HAVING DENTAL PROCEDURE PATIENT HAD COMPLAINTS OF ABDOMINAL PAIN, HEADACHE, NAUSEOUS - AFTER HE ATE. HE FELT PAIN IN THE AREAS WHERE THE STENT WAS PLACED. ALSO COMPLAINED OF FATIGUE. NO AUTOPSY WAS PERFORMED AS PCP DID NOT DEEM NECESSARY AND WAS TO BE SIGNING THE DEATH CERTIFICATE TODAY SO THAT IT CAN BE TAKEN TO THE FUNERAL HOME. THAT WAY, BURIAL PROCEEDINGS COULD TAKE PLACE AS SOON AS POSSIBLE.". PATIENT OUTCOME: "SUBJECT DECEASED.".

    Description of Event or Problem · 0

    "SITE WAS INFORMED TODAY 29 MAY 2024 THAT THE SUBJECT UNFORTUNATELY PASSED AWAY (B)(6) 2024. SITE HAS LOOKED THROUGH PATIENT'S RECORDS AND ARE UNABLE TO LOCATE ANYTHING IN REGARD TO ANY HOSPITALIZATIONS, ETC. WILL FOLLOW-UP WITH MORE INFORMATION AS SOON AS IT IS PROVIDED BY THE SITE. ADDITIONAL INFORMATION RECEIVED FROM THE SITE ON 05/30/2024: (B)(6) - 7 TEETH PULLED AT DENTIST; PROCEDURE WENT WELL AND PATIENT CAME HOME. (B)(6) - WAS FOUND DECEASED ON THE COUCH AT HIS UNCLE'S HOUSE. OVER THE PAST FEW WEEKS PRIOR TO PATIENT HAVING DENTAL PROCEDURE PATIENT HAD COMPLAINTS OF ABDOMINAL PAIN, HEADACHE, NAUSEOUS - AFTER HE ATE. HE FELT PAIN IN THE AREAS WHERE THE STENT WAS PLACED. ALSO COMPLAINED OF FATIGUE. NO AUTOPSY WAS PERFORMED AS PCP DID NOT DEEM NECESSARY AND WAS TO BE SIGNING THE DEATH CERTIFICATE TODAY SO THAT IT CAN BE TAKEN TO THE FUNERAL HOME. THAT WAY, BURIAL PROCEEDINGS COULD TAKE PLACE AS SOON AS POSSIBLE." PATIENT OUTCOME: "SUBJECT DECEASED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    696888 RELAY PRO NBS THORACIC STENT-GRAFT SYSTEM STENT, ENDOVASCULAR GRAFT, AORTIC MIH BOLTON MEDICAL, INC. 2310130319

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Male Death