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	Malfunction
Additional Manufacturer Narrative
(b)(4).No device problem found: review of device batch history records could find no issue with batch that would lead to issue reported during procedure.Cause not established: root cause of this event could not be established from information received or review of batch history records.This is the only event of this nature reported in last 5 years.A review of information received regarding the event was carried out by clinical risk and r&d departments and conclusion given was that this event is most likely related to coagulopathy / patient issue rather than device, it is unknown if the graft not being pre-soaked in saline or rifampicin/heparin prior to procedure as recommended in ifu contributed to this event.No graft was returned and no remaining grafts from batch were available for further investigation, therefore vascutek ltd.Now considers this complaint closed however, the issue will be tracked and trended as part of the on-going complaints trending and reporting process and if an adverse trend develops action may be taken at that time.
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 15mins 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: 8490475
• Report Number: 9612515-2019-00005
• Device Sequence Number: 13884098
• Product Code: DSY
• UDI-Device Identifier: 05037881106922
• UDI-Public: 05037881106922
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K952293
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/12/2019
• Initial Report FDA Received Date: 04/08/2019
• 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