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

Catalog Number 631608P

Device Problems Hole In Material (1293); Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/15/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A review of manufacturing and qc records confirmed that the device was manufactured to the required specification.Porosity test results for the whole batch of 19 were well below maximum porosity limit of 77ml/min.A 5-year review of similar events that covered all knitted grafts gave a low occurrence rate of 0.02% (complaints v sales).Only bifurcated part of the graft was returned to vascutek for evaluation, which is still on-going.The results of the evaluation will be communicated in the follow up report.

Event Description

Surgeon reported that the graft was leaking from several places at bifurcation.Surgeon suggested that some stitching was missing at bifurcation area.Also, surgeon suggested that one leg looked odd.There were two to three round spots where surface was missing.Graft started leaking when the surgeon opened the clamp.The defective part of the graft (bifurcation and legs) was cut off, bifurcation and legs from another graft (bbraun unigraft) were attached to the body of the affected graft.The blood loss was minimal (less than 10ml) as the leak was noticed immediately and controlled on time.There was no harm caused to the patient, for example, patient did not experience hitt.

Manufacturer Narrative

Two sections of the gelsoft plus bifurcate graft were returned to vascutek for investigation.It was not possible to carry out fluid pressure testing as only sections of the graft were returned.Visual inspection of the returned section of the graft did not show any faults, damage or missing stitches as reported.Upon closer analysis using a digital microscope a pinhole was noticed nearby to one of the stitches at bifurcation area.It was not possible to identify when and how this pinhole occurred.Samples were taken from both legs to analyse the structure of the material and identify any inconsistencies that may have caused the leak from the legs.Sem images were reviewed and no damage to the material structure was identified.The procedure for sewing of bifurcates was updated in july 2016 (after the complaint graft was manufactured) to include the visual aid of bad and good stitching.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.Vascutek considers this case closed.

Event Description

This report is being submitted as follow up # 1 for mfg.Report # 9612515-2018-00001 to provide additional information regarding graft analysis results.

• Brand Name: GELSOFT PLUS
• Type of Device: GELSOFT PLUS BIFURCATE
• Manufacturer (Section D): VASCUTEK LTD; newmains avenue; inchinnan business park; renfrewshire, PA4 9 RR; UK PA4 9RR
• MDR Report Key: 7340803
• MDR Text Key: 102455245
• Report Number: 9612515-2018-00001
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 05037881115528
• UDI-Public: 05037881115528
• Combination Product (y/n): N
• PMA/PMN Number: K955230
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 02/15/2018,05/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 06/30/2021
• Device Catalogue Number: 631608P
• Device Lot Number: 386646-9071
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2018
• Was the Report Sent to FDA?: No
• Device Age: 20 MO
• Event Location: Hospital
• Date Report to Manufacturer: 02/15/2018
• Date Manufacturer Received: 02/15/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention