MAUDE Adverse Event Report: VASCUTEK LTD GELSOFT; GELSOFT BIFURCATE

Model Number	GELSOFT BIFURCATE
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The site advised that the device is not available; therefore no evaluation of the graft was possible.(b)(4).Analysis of production records - a review of the retained qc and manufacturing records for this batch (with attention to all in process and base material porosity testing) confirmed that the batch was manufactured to its design specification.Trend analysis - review of similar complaints of leakage for all gelsoft branded devices gave an occurrence rate of (b)(4).Communication/interviews - additional information was requested/received from the clinician regarding the procedure.This information confirmed that the clinician used the device as per ifu guidelines.Device not returned - the site advised that the device is not available.No device problem found - no issue was found with the manufacturing of the batch (based on the review of the retained production records) cause not established - the root cause of the reported defect could not be determined.Vascutek ltd.Considers this event 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, if an adverse trend develops action may be taken at that time.
Event or Problem Description
Vascutek ltd's distributor in (b)(4) reported that during a procedure to treat an abdominal aortic aneurysm with a gelsoft bifurcate device on (b)(6) 2021, the implanting clinician reported blood leakage at the bifurcation and limb areas.The leak sites were arrested by placement of sutures.The patient suffered no harm or injury.

• Brand Name: GELSOFT
• Common Device Name: GELSOFT BIFURCATE
• Manufacturer (Section D): VASCUTEK LTD; newmains avenue; inchinnan business park; renfrewshire, PA4 9 RR; UK PA4 9RR
• MDR Report Key: 11736326
• Report Number: 9612515-2021-00013
• Device Sequence Number: 17062144
• Product Code: MAL
• UDI-Device Identifier: 05037881110486
• UDI-Public: 05037881110486
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: P890045/S1
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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): 04/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2023
• Device Model Number: GELSOFT BIFURCATE
• Device Catalogue Number: 632010-G
• Device Lot Number: 21476729
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/02/2021
• Initial Report FDA Received Date: 04/28/2021
• 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: Required Intervention