MAUDE Adverse Event Report: VASCUTEK LTD GELWEAVE; GELWEAVE BIFURCATE

Model Number GELWEAVE BIFURCATE

Device Problem Obstruction of Flow (2423)

Patient Problem Thrombosis/Thrombus (4440)

Event Date 11/19/2021

Event Type  Injury  

Event Description

This event was reported to vascutek via the panther study programme as follows: on (b)(6) 2018 a gelweave bifurcate graft was implanted.The following day (b)(6) 2019) post-operative acute occlusion of the left side of aortofemoral prosthesis occurred.The patient underwent a thrombectomy procedure and an adjustment to medication which appeared to resolve the issue without further complication.The site has indicated that this event is related to the procedure, but also possibly related to the device and patient pre-existing conditions.

Manufacturer Narrative

(b)(4).Type of investigation: historical data analysis - a similar event review was performed for reported occlusion/thrombosis with gelweave branded devices between jan 17 and jun 22.A similar event rate of (b)(4) was confirmed.Trend analysis - no negative trend was identified.Communication/interviews - further information has been requested.Device not accessible for testing - the graft remains insitu.Analysis if 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.Investigation findings: no device problem found - no issue has been found upon review of the retained device history records for this device/batch.Results pending completion of the investigation.Investigation conclusions: conclusion is not yet available as critical information has been requested from the site as well as the current status of the device.

Manufacturer Narrative

Manufacturers narrative section h6 investigation findings: code 213 - no device problem found - no issue has been found upon review of the retained device history records for this device/batch.Investigation conclusions: code 22 - known inherent risk of device - arterial or venous thrombosis are known and expected occurrences and is listed within current ifu's as a potential adverse event.Code 4315 - cause not established - the patient has significant co-morbidities that could have caused or contributed to this occurrence.Vascutek ltd requested clarification as to why this event was indicated as possibly device related, when no device deficiencies have been reported and also that all pre op/post op ct / xray imaging be provided to aid the investigation.Despite multiple requests, no additional information has been provided.Therefore no root cause can be definitively determined in this case.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

This event was reported to vascutek via the panther study programme as follows: on (b)(6) 2021 a gelweave bifurcate graft was implanted.The following day ( (b)(6) 2021) post-operative acute occlusion of the left side of aortofemoral prosthesis occurred.The patient underwent a thrombectomy procedure and an adjustment to medication which appeared to resolve the issue without further complication.The site has indicated that this event is related to the procedure, but also possibly related to the device and patient pre-existing conditions.

• Brand Name: GELWEAVE
• Type of Device: GELWEAVE BIFURCATE
• Manufacturer (Section D): VASCUTEK LTD; newmains avenue; inchinnan; glasgow, renrewshire PA49R R; UK PA49RR
• Manufacturer (Section G): VASCUTEK LTD; newmains avenue; inchinnan; glasgow, renrewshire PA49R R; UK PA49RR
• Manufacturer Contact: jason whittle ; newmains avenue; inchinnan; glasgow, renrewshire PA49R-R ; UK PA49RR
• MDR Report Key: 14773655
• MDR Text Key: 294533515
• Report Number: 9612515-2022-00008
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 05037881105833
• UDI-Public: 05037881105833
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K964665
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/05/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2024
• Device Model Number: GELWEAVE BIFURCATE
• Device Catalogue Number: 732010-G
• Device Lot Number: 21653483
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/30/2022
• Initial Date FDA Received: 06/22/2022
• Supplement Dates Manufacturer Received: 05/30/2022
• Supplement Dates FDA Received: 08/05/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/03/2021
• Is the Device Single Use?: Yes
• 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: 67 YR
• Patient Sex: Female
• Patient Weight: 67 KG