BEUDAMED
    FDA Adverse Event Death Summary report: N

    THORAFLEX HYBRID

    MDR report key: 22858270 · Received August 21, 2025

    Report

    Report Number
    9612515-2025-00069
    Event Type
    Death
    Date Received
    August 21, 2025
    Date of Event
    June 11, 2025
    Report Date
    October 17, 2025
    Manufacturer
    VASCUTEK LTD.
    Product Code
    QSK
    UDI-DI
    05037881031798
    PMA / PMN Number
    P210006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER NARRATIVE: CLINICAL CODE: 2067 -SEPSIS- BLOOD STREAM INFECTION WITH VANCOMYCIN RESISTANT ENTEROCOCCI (FAECUM), IMPACT CODE: 1802- DEATH - PATIENT PASSED AWAY ON (B)(6) 2025.SITE DETAILED REASON FOR DEATH AS "PALLIATIVE TREATMENT IN TERMS OF BEST SUPPORTIVE CARE AND ACCORDING TO PATIENT'S WILL". DEVICE PROBLEM CODE : 3190 - INSUFFICIENT INFORMATION - NO DEVICE FAILURE /DEFICIENCY HAS BEEN REPORTED. COMPONENT CODE: 4755 - PART/COMPONENT/SUB-ASSEMBLY TERM NOT APPLICABLE. TYPE OF INVESTIGATION: 4110 - TREND ANALYSIS: - THORAFLEX HYBRID SALES JAN 21 - JUN 25 VS THORAFLEX HYBRID INFECTION EVENTS JAN 21 - JUL 25 HAD AN OCCURRENCE RATE OF 0.044% NO TREND REQUIRING ACTION HAS BEEN IDENTIFIED. 4111 - COMMUNICATION INTERVIEW: ADDITIONAL INFORMATION RECEIVED ON 15 SEP 25 STATED THE GRAFT WAS NOT PRE-SOAKED IN RIFAMPICIN PRIOR TO IMPLANTATION, THE PATIENT DID NOT HAVE ANY KNOWN ALLERGIES AND BLOOD STREAM INFECTION WITH VANCOMYCIN RESISTANT ENTEROCOCCI (FAECUM) VRE" INCLUDING INFECTION OF THE AORTIC PROTHESIS. POSITIVE BLOOD CULTURE FOUND IN INTRA-SURGICAL SAMPLE TAKEN ON (B)(6) 2025. NO SURGICAL REPLACEMENT OF THE PROTHESIS PLANNED DUE TO OPERATIVE RISKS. THEREFORE CONSERVATIVE TREATMENT WITH MEDICATION. 3331 - ANALYSIS OF PRODUCTION RECORDS: FULL BATCH REVIEW PERFORMED FROM BASE FABRIC TO FINISHED PRODUCT FOR DEVICE ID- WHICH CONFIRMED THE BATCH WAS MANUFACTURED TO SPECIFICATION. 4117 - DEVICE NOT RETURNED: DEVICE REMAINS IMPLANTED. INVESTIGATION FINDINGS: 213 - NO DEVICE PROBLEM FOUND - DEVICE WAS MANUFACTURED TO SPECIFICATION AND REVIEW OF RETAINED STERILITY / ENDOTOXIN / BIOBURDEN RECORDS CONFIRM THE STERILITY OF THE DEVICE. TERUMO AORTIC GLASGOW HAVE NEVER RECOVERED THIS TYPE OF ORGANISM IN ANY OF OUR TESTING PROCESSES. INVESTIGATION CONCLUSION: 4315 - CAUSE NOT ESTABLISHED. BREAKDOWN: ·VRE: VANCOMYCIN-RESISTANT ENTEROCOCCI - A GROUP OF BACTERIAL STRAINS RESISTANT TO THE ANTIBIOTIC VANCOMYCIN. ·FM: REFERS SPECIFICALLY TO ENTEROCOCCUS FAECIUM, ONE OF THE SPECIES WITHIN THIS GROUP. CLINICAL RELEVANCE: ENTEROCOCCUS FAECIUM IS A TYPE OF BACTERIA COMMONLY FOUND IN THE HUMAN GUT. WHEN IT BECOMES RESISTANT TO VANCOMYCIN, IT CAN CAUSE SERIOUS INFECTIONS, ESPECIALLY IN HOSPITAL SETTINGS, SUCH AS: ·BLOODSTREAM INFECTIONS, ·URINARY TRACT INFECTIONS, ·SURGICAL SITE INFECTIONS. E. FAECIUM IS A NORMAL GUT COMMENSAL. IN IMMUNOCOMPROMISED OR CRITICALLY ILL PATIENTS, COLONIZATION CAN PROGRESS TO BLOODSTREAM INFECTION VANCOMYCIN-RESISTANT ENTEROCOCCUS FAECIUM (VREFM) IS COMMONLY ACQUIRED IN HEALTHCARE SETTINGS, ESPECIALLY IN ICUS, TRANSPLANT UNITS, OR LONG-TERM CARE FACILITIES USE OF CENTRAL VENOUS CATHETERS, URINARY CATHETERS, OR FEEDING TUBES PROVIDES A DIRECT ROUTE FOR BACTERIA TO ENTER THE BLOODSTREAM. ABDOMINAL OR THORACIC SURGERIES ALSO MAY DISRUPT MUCOSAL BARRIERS AND INCREASE INFECTION RISK. NO CAUSAL LINK BETWEEN THE EVENT AND THE DEVICE COULD BE ESTABLISHED. ADDITIONAL INFORMATION , CORRECTED CODES IN SECTION H6 B TO MATCH INVESTIGATION NARRATIVE.

    Additional Manufacturer Narrative · 0

    MANUFACTURER NARRATIVE: CLINICAL CODE: 2067 -SEPSIS- BLOOD STREAM INFECTION WITH VANCOMYCIN RESISTANT ENTEROCOCCI (FAECUM), IMPACT CODE: 1802- DEATH - PATIENT PASSED AWAY ON (B)(6) 2025. SITE DETAILED REASON FOR DEATH AS "PALLIATIVE TREATMENT IN TERMS OF BEST SUPPORTIVE CARE AND ACCORDING TO PATIENT'S WILL". DEVICE PROBLEM CODE : 3190 - INSUFFICIENT INFORMATION - NO DEVICE FAILURE /DEFICIENCY HAS BEEN REPORTED. COMPONENT CODE: 4755 - PART/COMPONENT/SUB-ASSEMBLY TERM NOT APPLICABLE. TYPE OF INVESTIGATION: 4110 - TREND ANALYSIS: - THORAFLEX HYBRID SALES (B)(6) VS THORAFLEX HYBRID INFECTION EVENTS (B)(6) HAD AN OCCURRENCE RATE OF 0.044% NO TREND REQUIRING ACTION HAS BEEN IDENTIFIED. 4111 - COMMUNICATION INTERVIEW: ADDITIONAL INFORMATION HAS BEEN REQUESTED TO AID THIS INVESTIGATION. 3331 - ANALYSIS OF PRODUCTION RECORDS: FULL BATCH REVIEW PERFORMED FROM BASE FABRIC TO FINISHED PRODUCT FOR DEVICE ID- WHICH CONFIRMED THE BATCH WAS MANUFACTURED TO SPECIFICATION. 4117 - DEVICE NOT RETURNED: DEVICE REMAINS IMPLANTED INVESTIGATION FINDINGS: 3233 - RESULTS PENDING COMPLETION OF INVESTIGATION. INVESTIGATION CONCLUSION: 11 - CONCLUSION NOT YET AVAILABLE AS INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    INFECTION EVENT REPORTED FORM THE EXTEND STUDY (B)(6). SUBJECT CAUCASIAN MALE( WHO WAS 79 AT THE TIME OF CONSENT TAKEN ON (B)(6) 2025) UNDERWENT AN ELECTIVE OPEN SURGICAL REPAIR OF THE AORTA WITH A THORAFLEX HYBRID PLEXUS DEVICE ON (B)(6) 2025, FOR FUSIFORM AORTIC ANEURYSM. ON POST-OPERATIVE DAY 8 ((B)(6) 2025), SUBJECT (B)(6) EXPERIENCED AN SAE( SERIOUS ADVERSE EVENT) OF INFECTION, FURTHER DETAILS STATING "BLOOD STREAM INFECTION WITH VANCOMYCIN RESISTANT ENTEROCOCCI (FAECUM), VRE (VANCOMYCIN-RESISTANT ENTEROCOCCUS).INCLUDING INFECTION OF THE AORTIC PROSTHESIS. POSITIVE BLOOD CULTURE FOUND IN INTRA-SURGICAL SAMPLE TAKEN ON (B)(6) 2025. EVENT IS ANTICIPATED AND SEVERE IN NATURE. EVENT WAS CONSIDERED POSSIBLY RELATED TO DEVICE, NOT RELATED TO DEVICE FAILURE/DEFICIENCY AND NOT RELATED TO PRE-EXISTING CONDITIONS. PATIENT PASSED AWAY ON (B)(6) 2025.SITE DETAILED REASON FOR DEATH AS "PALLIATIVE TREATMENT IN TERMS OF BEST SUPPORTIVE CARE AND ACCORDING TO PATIENT'S WILL". THIS REPORT IS BEING SUBMITTED AS FOLLOW UP #1 FOR MANUFACTURING REPORT NUMBER 9612515-2025-00069 TO PROVIDE EVENT CLOSURE INFORMATION FOR (B)(4).

    Description of Event or Problem · 0

    INFECTION EVENT REPORTED FORM THE EXTEND STUDY (NCT05639400). SUBJECT CAUCASIAN MALE( WHO WAS 79 AT THE TIME OF CONSENT TAKEN ON (B)(6) 2025) UNDERWENT AN ELECTIVE OPEN SURGICAL REPAIR OF THE AORTA WITH A THORAFLEX HYBRID PLEXUS DEVICE ON (B)(6) 2025, FOR FUSIFORM AORTIC ANEURYSM. ON POST-OPERATIVE DAY 8 (B)(6) 2025), SUBJECT (B)(6) EXPERIENCED AN SAE( SERIOUS ADVERSE EVENT) OF INFECTION, FURTHER DETAILS STATING "BLOOD STREAM INFECTION WITH VANCOMYCIN RESISTANT ENTEROCOCCI (FAECUM), VRE (VANCOMYCIN-RESISTANT ENTEROCOCCUS).INCLUDING INFECTION OF THE AORTIC PROSTHESIS. POSITIVE BLOOD CULTURE FOUND IN INTRA-SURGICAL SAMPLE TAKEN ON (B)(6) 2025. EVENT IS ANTICIPATED AND SEVERE IN NATURE. EVENT WAS CONSIDERED POSSIBLY RELATED TO DEVICE, NOT RELATED TO DEVICE FAILURE/DEFICIENCY AND NOT RELATED TO PRE-EXISTING CONDITIONS. PATIENT PASSED AWAY ON (B)(6) 2025. SITE DETAILED REASON FOR DEATH AS "PALLIATIVE TREATMENT IN TERMS OF BEST SUPPORTIVE CARE AND ACCORDING TO PATIENT'S WILL".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2203699 THORAFLEX HYBRID THORAFLEX HYBRID PLEXUS QSK VASCUTEK LTD. N/A 25537391 05037881031798

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Death