MAUDE Adverse Event Report: VASCUTEK LTD GELWEAVE; GELWEAVE VALSALVA

Model Number	GELWEAVE VALSALVA
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	Pericardial Effusion (3271)
Date of Event	06/10/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Type of investigation codes: analysis of production records - a review of the retained manufacturing/quality records confirmed that the device was manufactured to specifications.No previous complaints/issues have been logged for the remainder of the batch.Specific emphasis was directed toward the porosity results; which clearly indicate good results in the lower end of the test.Historical event analysis & trend analysis: a review of similar events for gelweave branded devices provided an occurrence (b)(4) (complaint v sales).No reports of leakage has been received for any of the remaining grafts from this batch.No negative trend was identified.Communication / interviews.- further information was requested from the site with regards to the circumstances of the event.Device not accessible for testing - device remains in situ and was not explanted.Investigation findings: no device problem found.Review of all retained manufacturing records (including porosity test records) confirm that the device was manufactured to specifications.Investigation conclusion: cause not established.Based on all available information provided by the site and that the actual device is not available, no determination of a root cause has been possible.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
This event was reported via the panther study as follows: a gelweave valsalva device was implanted on (b)(6) 2022.On (b)(6) 2022 it was detected that the patient was suffering from pericardial effusion (build-up of fluid within the pericardium sac); which was treated with a re-intervention by suturing bleeding at the distal anastomosis.

• Brand Name: GELWEAVE
• Common Device Name: GELWEAVE VALSALVA
• 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: 15093101
• Report Number: 9612515-2022-00010
• Device Sequence Number: 17433491
• Product Code: DSY
• UDI-Device Identifier: 05037881120119
• UDI-Public: 05037881120119
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K013022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/25/2022

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2024
• Device Model Number: GELWEAVE VALSALVA
• Device Catalogue Number: 730026ADP-G
• Device Lot Number: 21974007
• 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: 06/30/2022
• Initial Report FDA Received Date: 07/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/23/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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; Hospitalization
• Patient Age: 59 YR
• Patient Sex: Female
• Patient Weight: 80 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White