MAUDE Adverse Event Report: VASCUTEK LTD. GELWEAVE; GELWEAVE COSELLI GRAFT

Catalog Number	732410108/8S4-J
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	08/20/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer narrative: clinical code: 1888 - partial oozing from the main body and branches of the graft and postoperative infection: impact code: 4613- blood loss- hydrofit was then used to stop oozing.Device problem code : 1354 - leakage - event reported as blood oozing from the main body and branches of the graft component code: 4755 - part/component/sub-assembly term not applicable type of investigation: 4110 - trend analysis: a 4-year review of similar complaints gelweave sales jan 21 - oct 24 vs gelweave blood oozing.Body events jan 21 - nov 24 gave an occurrence rate of <0.001% no trend requiring action has been identified.4111 - communication interview: additional information has been requested.3331 - analysis of production records: full batch review performed from base fabric to finished product which showed the device 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.
Event or Problem Description
(operation type: thoracoabdominal aortic replacementevent) event reported as partial oozing from the main body and branches of the graft and postoperative infection: when the chest was reopened and thoracoabdominal aortic replacement was performed using the gelweave coselli graft, partial oozing was noted from the surface of the main body and branches of the graft.As the oozing was from some spots rather than the entire graft, the surgeon indicated that the gelatine may be uneven.Hydrofit was then used to stop oozing.After the surgery, the patient became infected and is still hospitalized.
Event or Problem Description
(operation type: thoracoabdominal aortic replacement event) event reported as partial oozing from the main body and branches of the graft and postoperative infection: when the chest was reopened and thoracoabdominal aortic replacement was performed using the gelweave coselli graft, partial oozing was noted from the surface of the main body and branches of the graft.As the oozing was from some spots rather than the entire graft, the surgeon indicated that the gelatine may be uneven.Hydrofit was then used to stop oozing.After the surgery, the patient became infected and is still hospitalized.This report is being submitted as follow up #1 for manufacturing report: 9612515-2024-00082 to provide event closure information for tag0105.
Additional Manufacturer Narrative
Manufacturer narrative: clinical code: 1888 - partial oozing from the main body and branches of the graft and postoperative infection: impact code: 4613- blood loss- hydrofit was then used to stop oozing.Device problem code: 1354- leakage - event reported as blood oozing from the main body and branches of the graft.Component code: 4755- part/component/sub-assembly term not applicable.Type of investigation: 4110- trend analysis: a 4-year review of similar complaints gelweave sales jan 21 - oct 24 vs gelweave blood oozing.Body events jan 21 - nov 24 gave an occurrence rate of (b)(4) no trend requiring action has been identified.4111- communication interview: additional information has been requested.3331- analysis of production records: full batch review performed from base fabric to finished product which showed the device was manufactured to specification.4117- device not returned: device remains implanted.Investigation findings: 213- no device problem found.4248- usage problem identified - ifu was not followed.Investigation conclusion: 67- no device problem found - on review of the retained manufacturing and quality records the device was manufactured to specification.Endotoxin, bioburden and environmental monitoring records for this period of manufacture were reviewed and showed no issues.Mrsa (methicillin-resistant staphylococcus aureus) has not been detected in any microbial testing of tag products, nor in any environmental monitoring or cleanroom areas.The sterilisation process used for tag products is eo (ethylene oxide) sterilisation, which is highly effective in eliminating mrsa.18- cause traced to user / failure to follow instructions- additional information received on 17 dec 24 from the site confirmed the device was not pre-soaked as per ifu, this step helps reduce leakage in the graft.

• Brand Name: GELWEAVE
• Common Device Name: GELWEAVE COSELLI GRAFT
• Manufacturer (Section D): VASCUTEK LTD.; newmains avenue; inchinnan buisness park; glasgow, renfrewshire PA4 9 RR; UK PA4 9RR
• Manufacturer (Section G): VASCUTEK LTD.; newmains avenue; inchinnan buisness park; glasgow, renfrewshire PA4 9 RR; UK PA4 9RR
• Manufacturer Contact: laura allan ; newmains avenue; inchinnan buisness park; glasgow, renfrewshire PA4 9-RR ; UK PA4 9RR
• MDR Report Key: 20877455
• Report Number: 9612515-2024-00082
• Device Sequence Number: 18105693
• Product Code: DSY
• UDI-Device Identifier: 05037881107233
• UDI-Public: 05037881107233
• 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: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Remedial Action: Repair
• Type of Report: Initial,Followup
• Report Date (Section B): 01/29/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2026
• Device Catalogue Number: 732410108/8S4-J
• Device Lot Number: 25455205
• 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: 11/21/2024
• Supplement Date Received by Manufacturer: 11/21/2024
• Initial Report FDA Received Date: 12/09/2024
• Supplement Report FDA Received Date: 01/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/05/2023
• 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