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

Model Number GELWEAVE

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Aneurysm (1708)

Event Date 03/11/2019

Event Type  Injury  

Event 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
• Type of Device: 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
• MDR Text Key: 141580540
• Report Number: 1124841-2019-10001
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 05037881106922
• UDI-Public: 05037881106922
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/12/2019,04/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• 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
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 82 YR