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

Model Number GESLOFT PLUS STRAIGHT

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problem Thrombosis/Thrombus (4440)

Event Date 08/18/2021

Event Type  Injury  

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 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
• Type of Device: 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
• MDR Text Key: 281849161
• Report Number: 9612515-2021-00027
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 05037881115047
• UDI-Public: 05037881115047
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K955230
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Date Manufacturer Received: 11/09/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR
• Patient Sex: Male