MAUDE Adverse Event Report: VASCUTEK LTD GELWEAVE; GELWEAVE PRE-CURVED 4 BRANCH PLEXUS

Model Number	UNKNOWN
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Seroma (2069)
Date of Event	07/16/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2024 , the surgery was successfully completed with vascular graft replacement (gelweave 4 branch graft).The patient was then discharged.On (b)(6) 2024, the patient underwent thoracotomy for suspected cardiac tamponade.Oozing of something similar to blood or seroma was observed around the gelweave valsalva graft.Hemostatic surgery was performed.Operation type: bentall, tar (understood to be total arterial revascularization) and cabg (understood to be coronary artery bypass graft) blood loss: unknown possibly device failure/ pre-existing condition/ procedure related patient outcome: the patient's condition was not serious.The patient has recovered.
Additional Manufacturer Narrative
Clinical code (e) 2069 - seroma: oozing of something similar to blood or seroma was observed around the gelweave valsalva graft.Impact code (f) 4625 - additional surgery: hemostatic surgery was performed.Medical device problem code (a) 1250 - fluid leak: blood loss by oozing around graft.Component code (g) 4755 - part/component/sub-assembly term not applicable: device has no distinct components.Type of investigation (b) 4110 - trend analysis: a 5 year review of similar complaints (medical event > seroma) gave an occurrence rate of (b)(4) (complaints vs sales).No trend requiring action was identified in this similar event review.4111 - communication/interviews: additional information was requested on 19 jul 2024.Further information has been received on 02 aug 2024.The patient was confirmed to have asthma and pneumonia, the graft was undamaged, forceps were used, and the graft had no twists or kinks.There was no evidence of infection.3331 - analysis of production records: a review of manufacturing and qc records confirmed that there were no issues with the manufacture of the device.4117 - device not accessible for testing: the device remains implanted.Investigation findings (c) 3233 - results pending completion of investigation: investigation conclusions (d) 11 - conclusion not yet available:.
Additional Manufacturer Narrative
Clinical code (e).2069 - seroma: oozing of something similar to blood or seroma was observed around the gelweave valsalva graft.Impact code (f).4625 - additional surgery: hemostatic surgery was performed.Medical device problem code (a).1250 - fluid leak: blood loss by oozing around graft.Component code (g).4755 - part/component/sub-assembly term not applicable: device has no distinct components.Type of investigation (b).4110 - trend analysis: a 5 year review of similar complaints (medical event > seroma) gave an occurrence rate of (b)(4)(complaints vs sales).No trend requiring action was identified in this similar event review.4111 - communication/interviews: additional information was received on 02 aug 24 confirmed that the graft was patent and that no kink / twisting of the graft was observed.There was no damage observed during implantation.Atraumatic instruments like forceps were used and evidence of infection were noticed.The patient had pre-medical history of asthma and pneumonia.On 17 sep 24 it was confirmed that no leakage was reported from the junctions of the device.3331 - analysis of production records: a review of manufacturing and qc records confirmed that there were no issues with the manufacture of the device.No causal link between the event and device deficiency could be established.4117 - device not accessible for testing: the device remains implanted.Investigation findings (c).213: no device problem found: no causal link between the event and a device deficiency could be established.Investigation conclusions (d).4315: cause not established: no causal link between the device and the event could be established.Due to no scans/images/product return/ further information available for the event.
Event or Problem Description
On (b)(6) 2024, the surgery was successfully completed with vascular graft replacement (gelweave 4 branch graft).The patient was then discharged.On (b)(6) 2024, the patient underwent thoracotomy for suspected cardiac tamponade.Oozing of something similar to blood or seroma was observed around the gelweave valsalva graft.Hemostatic surgery was performed.Operation type: bentall, tar (understood to be total arterial revascularization) and cabg (understood to be coronary artery bypass graft) blood loss: unknown possibly device failure/ pre-existing condition/ procedure related patient outcome: the patient's condition was not serious.The patient has recovered.Follow up 1: this event is being submitted as a follow up #1 for mfg report number 9612515-2024-00054 to provide event closure information for (b)(4).

• Brand Name: GELWEAVE
• Common Device Name: GELWEAVE PRE-CURVED 4 BRANCH PLEXUS
• Manufacturer (Section D): VASCUTEK LTD; newmains avenue; inchinnan buiness park; renfrewshire, glasgow PA49R R; UK PA49RR
• Manufacturer (Section G): VASCUTEK LTD.; newmains avenue; inchinnan business park; renfrewshire, glasgow PA49R R; UK PA49RR
• Manufacturer Contact: laura allan ; newmains avenue; inchinnan buiness park; renfrewshire, glasgow PA49R-R ; UK PA49RR
• MDR Report Key: 19972593
• Report Number: 9612515-2024-00054
• Device Sequence Number: 7001497
• Product Code: DSY
• UDI-Device Identifier: 05037881998459
• UDI-Public: 05037881998459
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K090987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Remedial Action: Repair
• Type of Report: Initial,Followup
• Report Date (Section B): 10/08/2024

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2025
• Device Model Number: UNKNOWN
• Device Catalogue Number: 73261088/10SA-J
• Device Lot Number: 25322527
• 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: 07/19/2024
• Supplement Date Received by Manufacturer: 07/19/2024
• Initial Report FDA Received Date: 08/13/2024
• Supplement Report FDA Received Date: 10/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/07/2023
• 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: Required Intervention
• Patient Sex: Unknown