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

Model Number	GELSOFT PLUS BIFURCATE
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/23/2021
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.Health effect: clinical code: (b)(4): no clinical signs/symptoms or conditions were reported.Health effect: impact code: (b)(4): this leakage event had no reported direct health consequence or impact for the patient.Medical device problem code: (b)(4): material integrity problem reported.Type of investigation: (b)(4): trend analysis: review of similar complaints of leakage for all gelsoft branded devices gave an occurrence rate of (b)(4).Type of investigation: (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.Type of investigation: (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.Type of investigation: (b)(4) device not returned: the site advised that the device is not available.Investigation findings: (b)(4): no device problem found: no issue was found with the manufacturing of the batch (based on the review of the retained production records).Investigation conclusions: (b)(4): 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
During a procedure (an emergency replacement for a common iliac artery aneurysm) on (b)(6) 2021, a clinician reported blood leakage at the bifurcation area of the gelsoft plus bifurcate graft.The clinician also indicated that the stitching at the crutch appeared loose.The leak was arrested by the placement of two sutures.

• Brand Name: GELSOFT PLUS
• Common Device Name: GELSOFT PLUS BIFURCATE
• Manufacturer (Section D): VASCUTEK LTD; newmains avenue; inchinnan business park; renfrewshire, PA4 9 RR; UK PA4 9RR
• MDR Report Key: 11626903
• Report Number: 9612515-2021-00012
• Device Sequence Number: 14427758
• Product Code: DSY
• UDI-Device Identifier: 05037881115511
• UDI-Public: 05037881115511
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K00207
• 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): 04/07/2021

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: 09/30/2021
• Device Model Number: GELSOFT PLUS BIFURCATE
• Device Catalogue Number: 631407P-J
• Device Lot Number: 21439340
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/24/2021
• Initial Report FDA Received Date: 04/07/2021
• 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