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

Model Number BIFURCATE

Device Problems Material Puncture/Hole (1504); Material Perforation (2205); Material Integrity Problem (2978)

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

Event Date 04/11/2021

Event Type  malfunction  

Manufacturer Narrative

Manufacturers narrative: (b)(4).Vascutek ltd.Is still awaiting possible video of event for further investigation and clarification of circumstances of event.Further information and conclusion of event findings will be reported in next follow up / final report.

Event Description

Patient being treated for aaa with gelsoft bifurcate.Dr.States he found a hole in graft after removing from packaging device was implanted however no further information on how hole was managed.No patient consequences reported.

Manufacturer Narrative

Manufacturers narrative: section h6: health effect - clinical code 4582 - no clinical signs, symptoms or conditions - no reported health consequence for patient.Heakth effect - impact code 2199 - no health consequences or impact - no reported impact or consequence for patient.Medical device problem code: 2978 - material integrity problem, 2205 - material perforation, 1504 - material puncture / hole - reported that there was a hole in device when removed from packaging - no further information was received on location of hole.Doctor sutured hole to stop reported leakage.Component code: 4755 - part/component/sub-assembly term not applicable - gelsoft bifurcate is manufactured from a single knitted tube and does not have any additional sub-assemblies or parts connected.Type of investigation: 4110 - trend analysis - a review of similar events for all gelsoft/gelsoft plus variants / (b)(4).4111- communication /interviews - several requests for further information were made to site for further information on the event.3331- analysis of production records - a review of qc manufacturing and porosity testing of batch was performed - no issue was found on review and all porosity testing on base material and gelled product passed acceptance criteria.4117 - device not accessible for testing - device remains implanted and is therefore not available for further investigation.Investigation findings: 213 - no issue was found on review of device history records.Investigation conclusions: 4315- cause not established - root cause of the leakage could not be established from review of device history records or infomation and video received.No further investigation was possible as device remainss in situ.Vascutek ltd.Now considers this complaint 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 Description

Patient being treated for aaa with gelsoft bifurcate.Dr.States he found a hole in graft after removing from packaging device was implanted however no further information on how hole was managed.No patient consequences reported.Further information was received on 29-apr indicating that the hole was sutured to prevent further leakage.The graft was also pre-soaked prior to procedure as per ifu recommendations however for how long was unknown a video of leakage was also received on 7th may however no further information on cause of hole could be determined from this video.

• 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
• MDR Report Key: 11788860
• MDR Text Key: 278151260
• Report Number: 9612515-2021-00015
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• PMA/PMN Number: K162803
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 06/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2023
• Device Model Number: BIFURCATE
• Device Catalogue Number: 631608-G
• Device Lot Number: 21473450
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention