MAUDE Adverse Event Report: VASCUTEK LTD. GELWEAVE; GELWEAVE ANTE-FLO

Model Number	ANTE-FLO
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Seroma (2069)
Date of Event	09/18/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Seroma formation detected upon clinical follow up.Patient required hospitalisation.Surgical intervention was required.The device was explanted from the patient.Adverse event without identified device or use problem.Not related to any sub assemblies type of investigation.A review of qc, manufacturing and physical test records was carried out and show the batch was manufactured to design specification and met all in process and bass material physical test acceptance criteria.A 5-year similar event review was performed on seroma events related to gelweave product.The device was explanted, but its disposition is unknown.Investigation findings, no issue was found with the manufacture of this batch on review of production records.Investigation conclusion, cause not established.Vascutek ltd.Considers this event as closed.
Event or Problem Description
Seroma: a follow up ct scan revealed formation of a seroma around the graft.Seroma formation was assumed to be due to plasma component leakage.Re-operation was performed.No details provided.Initial operation type: total; arch replacement.The patient was reported to be in serious condition - current condition is unknown.

• Brand Name: GELWEAVE
• Common Device Name: GELWEAVE ANTE-FLO
• Manufacturer (Section D): VASCUTEK LTD.; newmains avenue; inchinnan business park; renfrewshire, PA4 9 RR; UK PA4 9RR
• MDR Report Key: 10703943
• Report Number: 9612515-2020-00014
• Device Sequence Number: 19744110
• Product Code: DSY
• UDI-Device Identifier: 05037881106519
• UDI-Public: 05037881106519
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K040829
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/26/2020

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: 02/28/2023
• Device Model Number: ANTE-FLO
• Device Catalogue Number: 734026/10S
• Device Lot Number: 17206421
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/26/2020
• Initial Report FDA Received Date: 10/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention