MAUDE Adverse Event Report: VASCUTEK LTD GELWEAVE; GELWEAVE BIFURCATE

Model Number	GELWEAVE BIFURCATE
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Codes	Renal Failure (2041); Ruptured Aneurysm (4436); Thrombosis/Thrombus (4440)
Date of Event	09/12/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).A review of qc, manufacturing and physical test records was carried out and show the batch was manufactured to design specification and met all in process and bass material physical test acceptance criteria.Historical data analysis - a 5-year similar event review was performed on thrombus/occlusion events related to gelweave product - this gave an occurrence rate of 0.003% (complaints v sales) device not accessible for testing - the device was explanted, but its disposition is unknown.(b)(4).Considers this event as closed.
Event or Problem Description
Patient was implanted with a gelweave bifurcate device on (b)(6) 2020.The following day, the clinician confirmed thrombosis post-op.The patient showed low levels of blood pressure.Patient suffered hypovolemic shock due to aaa rupture and acute renal failure which resulted in patient death.Clinician confirmed that the event is not related to a device failure and that it was related to a patient pre-existing condition.

• Brand Name: GELWEAVE
• Common Device Name: GELWEAVE BIFURCATE
• Manufacturer (Section D): VASCUTEK LTD; newmains avenue; inchinnan business park; renfrewshire, PA4 9 RR; UK PA4 9RR
• MDR Report Key: 10648081
• Report Number: 9612515-2020-00013
• Device Sequence Number: 2963186
• Product Code: DSY
• UDI-Device Identifier: 05037881105819
• UDI-Public: 05037881105819
• Combination Product (Y/N): N
• Initial Reporter Country: ID
• PMA/510(K) Number: K964665
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/08/2020

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: 04/30/2022
• Device Model Number: GELWEAVE BIFURCATE
• Device Catalogue Number: 731608
• Device Lot Number: 17810371
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/12/2020
• Initial Report FDA Received Date: 10/08/2020
• 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: Death
• Patient Age: 72 YR