MAUDE Adverse Event Report: VASCUTEK LTD GELSOFT; GELSOFT BIFURCATE

Model Number GELSOFT BIFURCATE

Device Problem Material Integrity Problem (2978)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/01/2021

Event Type  malfunction  

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 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
• Type of Device: GELSOFT 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: 11736326
• MDR Text Key: 247730160
• Report Number: 9612515-2021-00013
• Device Sequence Number: 1
• Product Code: MAL
• UDI-Device Identifier: 05037881110486
• UDI-Public: 05037881110486
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: P890045/S1
• 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: 04/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/02/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/02/2020
• 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): Required Intervention