MAUDE Adverse Event Report: VASCUTEK LTD. GELSOFT; DEVICE TYPE NOT CONFIRMED

Model Number BIFURCATE

Device Problems Material Integrity Problem (2978); Material Split, Cut or Torn (4008)

Patient Problem Insufficient Information (4580)

Event Date 05/21/2021

Event Type  malfunction  

Manufacturer Narrative

Manufacturers narrative patient information - only patient age and sex provided.Suspect medical device: no device details provided - site initially reported device was a gelsoft plus however this was not sold till 1995.However, gelsoft (not plus) devices were shipped to (b)(4) in 1991.Procode: dsy entered as procode as unknown device type.(b)(4).A section of the device was returned for investigation however, the section returned was from a leg of the bifurcate device and was not from the area of tear.Initial investigation of device shows that this device may not be either a gelsoft or gelsoft plus device - further decontamination and investigation will need to be performed to identify if device was manufactured by vascutek.(b)(4).

Event Description

This event was reported to (b)(6) by the hospital - no report was received directly from dr.Or hospital.(b)(6) informed vascutek ltd.On 25th may of an issue as follows in 1991 (exact date not specified) the patient received a bifurcate-prosthesis for lerich's syndrome.After (b)(6) years there is a longitudinal opening of the prosthesis over 7cm along the black prosthesis stripes.Patient consequences: large left spurium femoro-iliac aneurysm.Operation currently required, no health consequences for the patient.It is believed operation to explant device has been carried out as a small section of the graft was returned for investigation.

Manufacturer Narrative

Manufacturers narrative: summary of the returned sample analysis: the provided section diameter measured 10mm with a width of approx.1cm.A textiles analysis was performed to identify the material/device type as the black line present on the sample is not indicative of a gelsoft branded device.Visual inspection of the sample concluded that this material was not manufactured by vascutek ltd.For the following reasons.1) the complaint fabric only has one black thread moving in a zig-zag tricot stitch across 2 needles.2) gelsoft plus fabric has 2 separate black threads moving in a zig-zag stitch with a 4-needle underlap moving across 4 needle spaces.Other observations/ comments during textiles analysis: the white yarn appears under magnification to be similar to material manufactured by vascutek ltd, with a thinner yarn on the inner bars and a thicker yarn on the outside, but from the inspection it displays a basic tricot stitch (one needle overlap) whereas material manufactured by vascutek ltd stich formation on the inner bars is a koper stitch (2 needle overlap).This is what gives vascutek ltd.Fabric better stability and uniformity as well as increasing porosity and burst strength.In conclusion, the sample provided was not manufactured by vascutek ltd.Section h6: investigation findings - code 4247 - appropriate term/code is not available - analysis of the sample confirmed that the structure of the sample was not representative of a vascutek manufactured device.Conclusions findings - code 4316 - appropriate term/code is not available - the returned device was not manufactured by vascutek ltd.Vascutek considers this complaint as closed.

• Brand Name: GELSOFT
• Type of Device: DEVICE TYPE NOT CONFIRMED
• Manufacturer (Section D): VASCUTEK LTD.; newmains avenue; inchinnan business park; renfrewshire, PA4 9 RR; UK PA4 9RR
• MDR Report Key: 12023065
• MDR Text Key: 278151135
• Report Number: 9612515-2021-00018
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Type of Report: Initial,Followup
• Report Date: 07/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BIFURCATE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2021
• Date Manufacturer Received: 05/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 83 YR