MAUDE Adverse Event Report: VASCUTEK LTD GELWEAVE; GELWEAVE BIFURCATE

Model Number GELWEAVE BIFURCATE

Device Problem Obstruction of Flow (2423)

Patient Problems Renal Failure (2041); Ruptured Aneurysm (4436); Thrombosis/Thrombus (4440)

Event Date 09/12/2020

Event Type  Injury  

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 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
• Type of Device: GELWEAVE BIFURCATE
• 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: 10648081
• MDR Text Key: 210389690
• Report Number: 9612515-2020-00013
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 05037881105819
• UDI-Public: 05037881105819
• Combination Product (y/n): N
• Reporter Country Code: ID
• PMA/PMN Number: K964665
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/12/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/29/2019
• 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): Death
• Patient Age: 72 YR