MAUDE Adverse Event Report: VASCUTEK LTD GELSOFT PLUS; GELSOFT PLUS STRAIGHT

Model Number	GESLOFT PLUS STRAIGHT
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	08/18/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Type of investigation: historical data analysis - a five-year review of similar reported thrombosis/occlusive events relating to gelsoft branded grafts was completed, an occurence rate of (b)(4) (complaints v sales) was confirmed and no negative trend was detected analysis of production records - qc, manufacturing and physical test records of the base material were retrieved and reviewed and show that the batch was manufactured to design specification and all tests met acceptance criteria.Communication/interviews further information on event and its circumstances was requested from the reporting site (ct data) as well as clarification of the event/ device relationship.Analysis of data provided by user / third party - ct data from implant to date of event confirmed that the patient has had previous occlusive formations within this graft and within other devices that have been implanted (e.G.An insitu fevar device), in which the ca vessel stent is also occluded.Device not returned - the actual device involved in the adverse event will not be returned as it remains insitu within the patients anatomy.Investigation findings: no device problem found - no issue has been found on review of device history records of any issue with the manufacture of this device.Investigation conclusions: adverse event related to patient condition - no graft defect was detected during the ct data review with no visible kinking which may have affected flow.Thrombus was detected within an existing fevar device and the ca stent was occluded.The patient has a previous and on going arterial disease with peripheral arterial occlusive disease which is being treated with medications.Vascutek ltd.Considers this event as closed.Further action is not planned, 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
Event reported via the (b)(6) study on (b)(6) 2021.Event reported as "thrombosis of the patients subticular femoral popliteal bypass on the right".Patient was admitted on (b)(6) 2021 & a thrombectomy procedure was performed patient was discharged on (b)(6) 2021.Event reported as possibly device related issue resolved without sequelae.

• Brand Name: GELSOFT PLUS
• Common Device Name: GELSOFT PLUS STRAIGHT
• Manufacturer (Section D): VASCUTEK LTD; newmains avenue; inchinnan business park; renfrewshire, PA4 9 RR; UK PA4 9RR
• Manufacturer (Section G): VASCUTEK LTD; newmains avenue; inchinnan business park; renfrewshire, PA4 9 RR; UK PA4 9RR
• Manufacturer Contact: jason whittle ; newmains avenue; inchinnan business park; renfrewshire, PA4 9-RR ; UK PA4 9RR
• MDR Report Key: 12950082
• Report Number: 9612515-2021-00027
• Device Sequence Number: 17371469
• Product Code: DSY
• UDI-Device Identifier: 05037881115047
• UDI-Public: 05037881115047
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K955230
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/08/2021

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2022
• Device Model Number: GESLOFT PLUS STRAIGHT
• Device Catalogue Number: 636008P-G
• Device Lot Number: 17602633
• 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: 11/09/2021
• Initial Report FDA Received Date: 12/07/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 Age: 71 YR
• Patient Sex: Male