MAUDE Adverse Event Report: VASCUTEK LTD GELSOFT; GELSOFT DOUBLE BIFURCATE

Model Number	GELSOFT DOUBLE BIFURCATE
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/25/2021
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).Review of similar complaints of leakage for all gelsoft branded devices gave an occurrence rate of b4.Additional information was requested from the clinician regarding the procedure.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.The site advised that the device is not available.No issue was found with the manufacturing of the batch (based on the review of the retained production records).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 (b)(4) distribution partner ((b)(4)) reported an incidence of blood leakage of a gelsoft bifurcate graft.The graft was originally implanted on (b)(6) 2019.The patient underwent a laparotomy procedure on (b)(6) 2021 for the removal of a pseudo aneurysm; it was noted after the removal of the aneurysm blood leakage was observed from the in-situ gelsoft graft.The event was reported to vascutek ltd.As possibly device related.

• Brand Name: GELSOFT
• Common Device Name: GELSOFT DOUBLE BIFURCATE
• Manufacturer (Section D): VASCUTEK LTD; newmains avenue; inchinnan business park; renfrewshire, PA4 9 RR; UK PA4 9RR
• MDR Report Key: 11471915
• Report Number: 9612515-2021-00009
• Device Sequence Number: 4537711
• Product Code: DSY
• UDI-Device Identifier: 05037881110011
• UDI-Public: 05037881110011
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P890045/S1
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• 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): 03/12/2021

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: 02/29/2024
• Device Model Number: GELSOFT DOUBLE BIFURCATE
• Device Catalogue Number: 631809DB
• Device Lot Number: 17705600
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/26/2021
• Initial Report FDA Received Date: 03/12/2021
• 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