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

Model Number 632010P

Device Problem Material Deformation (2976)

Patient Problem Insufficient Information (4580)

Event Date 04/13/2021

Event Type  malfunction  

Manufacturer Narrative

Manufacturers narrative: (b)(4).

Event Description

Event reported to vascutek ltd from panther study.Gelsoft plus bifurcate was implanted on (b)(6) 2020 to treat an aorto-iliac aneurysm.On (b)(6) 2021 kinking of left graft leg close to bifurcation: patient reported gluteal and leg claudication.Event was reported as related to the device.In on (b)(6) 2021 stenting of left graft leg and internal iliac artery was carried out.Patient recovered.Event resolved without sequelae.

Event Description

This report is being submitted as follow up #1 for mfg.Report # 9612515-2022-00015 ((b)(4)) to provide event closure information.

Manufacturer Narrative

Investigation findings : 213 - no device problem found - no device deficiency was reported.Investigation conclusion: 4310 - cause cannot be traced to the device-on 16 nov 22 jpeg images of the scan were received and reviewed by clinical study manager.Image review showed that there does not appear to be any significant kinking of the left leg of the device this may have been cut too long or there is possibly something at the posterior of the device at the bifurcation.It was also stated on the intake that there was no device deficiency.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.

• Brand Name: GELSOFT PLUS
• Type of Device: GELSOFT PLUS BIFURCATE
• Manufacturer (Section D): VASCUTEK LTD.; newmains avenue; inchinnan business park; glasgow, 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; glasgow, renfrewshire PA4 9-RR ; UK PA4 9RR
• MDR Report Key: 15506238
• MDR Text Key: 306297216
• Report Number: 9612515-2022-00015
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K955230
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2023
• Device Model Number: 632010P
• Device Catalogue Number: 632010P-G
• Device Lot Number: 21433969
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/02/2022
• Initial Date FDA Received: 09/29/2022
• Supplement Dates Manufacturer Received: 09/02/2022
• Supplement Dates FDA Received: 11/30/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/14/2020
• 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
• Patient Age: 66 YR
• Patient Sex: Male