MAUDE Adverse Event Report: VASCUTEK LTD GELWEAVE; GELWEAVE STRAIGHT

Model Number	GELWEAVE STRAIGHT
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Kidney or Urinary Problem (4503)
Date of Event	12/13/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device is not available for evaluation as it remains in-situ.(b)(4).
Event or Problem Description
On december 13, type i vascular replacement was performed using 20mm diameter gelweave graft for an infrarenal abdominal aortic aneurysm , on the day of surgery , creatinine increased and the patient was diagnosed with acute kidney injury.
Additional Manufacturer Narrative
Investigation findings - code 3221 - no findings are available - additional information regarding the circumstances of this event and the event/device relationship to be clarified; however, no information or clarification was provided by the site.Investigation conclusion - code 67- no problem identified - review of the retianed manufacturing and quality records confirms that the device/batch was manufactured to specifications.Investigation conclusion - code 4315 - cause not established - the cause of the reported increased creatinine levels with acute kidney injury could not be established as no additional information was prvided by the site.Vascutek ltd considers this case 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 or Problem Description
On december 13, type i vascular replacement was performed using 20mm diameter gelweave graft for an infrarenal abdominal aortic aneurysm , on the day of surgery , creatinine increased and the patient was diagnosed with acute kidney injury.The event was reported as possibly deice related.

• Brand Name: GELWEAVE
• Common Device Name: GELWEAVE 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: 13289142
• Report Number: 9612515-2022-00001
• Device Sequence Number: 11864370
• Product Code: DSY
• UDI-Device Identifier: 05037881105642
• UDI-Public: 05037881105642
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K952293
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/10/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2022
• Device Model Number: GELWEAVE STRAIGHT
• Device Catalogue Number: 735020-J
• Device Lot Number: 21965592
• 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: 12/18/2021
• Supplement Date Received by Manufacturer: 12/18/2021
• Initial Report FDA Received Date: 01/19/2022
• Supplement Report FDA Received Date: 03/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/05/2021
• 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: Other
• Patient Sex: Unknown