MAUDE Adverse Event Report: VASCUTEK LTD. GELWEAVE; GELWEAVE STRAIGHT GELATIN IMPREGNATED WOVEN VASCULAR PROSTHESIS,

Model Number	GELWEAVE
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	03/11/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Alleged deficiency description: clotting occurred during a procedure for ascending aortic replacement for aneurysmal disease.While cross clamp was still on around 60 minutes into the bypass clotting occurred on inner and outer surface of graft.It delayed the procedure by around 15 minutes as when clotting was noticed they had to irrigate the left ventricle and the left atrium.Patient was fully heparinised and last active clotting factor(act) was checked around 15 mins prior to procedure and was 500+ seconds.No clotting was noticed on the pump filter or reservoirs.Graft not pre-soaked prior to use as recommended by ifu.

• Brand Name: GELWEAVE
• Common Device Name: GELWEAVE STRAIGHT GELATIN IMPREGNATED WOVEN VASCULAR PROSTHESIS,
• Manufacturer (Section D): VASCUTEK LTD.; newmains avenue; inchinnan business park; renfrewshire, PA4 9 RR; UK PA4 9RR
• MDR Report Key: 8501316
• Report Number: 1124841-2019-10001
• Device Sequence Number: 2689930
• Product Code: DSY
• UDI-Device Identifier: 05037881106922
• UDI-Public: 05037881106922
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/08/2019
• Report Date (Section F): 03/12/2019

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: 02/28/2022
• Device Model Number: GELWEAVE
• Device Catalogue Number: 733038
• Device Lot Number: 16135513
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/11/2019
• Device Age: 13 MO
• Event Location: Hospital
• Date Report to Manufacturer: 03/12/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/10/2019
• 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: Other
• Patient Age: 82 YR