MAUDE Adverse Event Report: VASCUTEK LTD THORAFLEX HYBRID; THORAFLEX HYBRID ANTE-FLO

Catalog Number	THA2830X100A-G
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Anemia (1706)
Date of Event	05/01/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Clinical code: 1706 - anemia: the site reported the event as post operative anaemia.Impact code: 2199 - no health consequences or impact: the event was resolved without sequalae and the patient remains on the study.4613- minor injury/ illness / impairment- the type of recovery was resolved with treatment.Medical device problem: 3190 - insufficient information: awaiting information from the site.Component code: 4755 - part/component/sub-assembly term not applicable.Type of investigation: 3331 - analysis of production records: a review of the manufacturing and quality control records for this batch confirmed that the product was manufactured to specification.4110 - trend analysis: a 4 year review was performed for thoraflex hybrid > medical event > nature of event (anemia) this gave an occurrence rate of less than 0.001%.No trend identified that required action at this time.4111 - communication/interviews: additional information has been requested, waiting on information from the site.4117 - device no accessible for testing: the device remains implanted.Investigation findings: 3233 - results pending completion of investigation.Investigation conclusion: 11 - conclusion not yet available.
Event or Problem Description
Event name: post-operative anaemia.Extend-001 study (b)(4), patient: (b)(6), post operative day 1 (on (b)(6) 2025), had a low blood count.Patient outcome: the site have indicated that no action was taken to treat the adverse event but that the type of recovery was resolved with treatment.The event was considered resolved on post-op day 11 (on (b)(6) 2025).The event was moderate in severity.
Additional Manufacturer Narrative
Clinical code: 1706 - anemia: the site reported the event as post operative anaemia.Impact code: 2199 - no health consequences or impact: the event was resolved without sequalae and the patient remains on the study.4613- minor injury/ illness / impairment- the type of recovery was resolved with treatment.Medical device problem: 2993- adverse event without identified device or use problem: a full batch review was performed for (b)(4), and no issues were identified during manufacturing process from raw materials to finished products.Since minimal information/ post-op scans was provided for the complaint to confirm on the root cause of anaemia that could be determined.Component code: 4755 - part/component/sub-assembly term not applicable.Type of investigation: 3331 - analysis of production records: a full batch review was performed for (b)(4), and no issues were identified during manufacturing process from raw materials to finished products.4110 - trend analysis: a 4 year review was performed for thoraflex hybrid, medical event, nature of event (anemia) this gave an occurrence rate of less than 0.001%.No trend identified that required action at this time,.4111 - communication/interviews: additional information was received on 23 jul 25 confirming the patient had latex allergy or anaphylactic reaction , however not related to anaemia.Patient was medically treated in preparation for the procedure with prophylactic antibiotics.There is no angiogram for this subject because he did not have an extension procedure.4117 - device no accessible for testing: the device remains implanted.Investigation findings: 3221- no findings available- the site had provided minimal information regarding the complaint.213- no device problem found- site confirmed the event was not related to a device failure/deficiency.A full batch review confirmed no issues were identified during manufacturing process from raw materials to finished products.Investigation conclusion: 4315 - cause not established- due to the limited information and lack of post-operative scans, determining the underlying cause of the anaemia could not be confirmed.67- no problem detected- site confirmed the event was not related to a device failure/deficiency.A full batch review was performed for (b)(4), and no issues were identified during manufacturing process from raw materials to finished products.
Event or Problem Description
Event name: post-operative anaemia.Extend-001 study, ((b)(6)), patient (b)(6), post operative day 1 ((b)(6) 2025), had a low blood count.Patient outcome: the site have indicated that no action was taken to treat the adverse event but that the type of recovery was resolved with treatment.The event was considered resolved on post-op day 11 ((b)(6) 2025).The event was moderate in severity.This report is being submitted as follow up #1 for manufacturing report number 9612515-2025-00059 to provide event closure information for (b)(4).

• Brand Name: THORAFLEX HYBRID
• Common Device Name: THORAFLEX HYBRID ANTE-FLO
• Manufacturer (Section D): VASCUTEK LTD; newmains avenue; inchinnan; glasgow, PA49R R; UK PA49RR
• Manufacturer (Section G): VASCUTEK LTD; newmains avenue; inchinnan; glasgow, PA49R R; UK PA49RR
• Manufacturer Contact: laura allan ; newmains avenue; inchinnan; glasgow, PA49R-R ; UK PA49RR
• MDR Report Key: 22233562
• Report Number: 9612515-2025-00059
• Device Sequence Number: 20838019
• Product Code: QSK
• UDI-Device Identifier: 05037881026923
• UDI-Public: 05037881026923
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P210006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/12/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: THA2830X100A-G
• Device Lot Number: 25150734
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2025
• Supplement Date Received by Manufacturer: 05/20/2025
• Initial Report FDA Received Date: 06/17/2025
• Supplement Report FDA Received Date: 08/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/09/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 74 YR
• Patient Sex: Female