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

Model Number GELSOFT PLUS BIFURCATE

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 05/07/2022

Event Type  Injury  

Event Description

On (b)(6) 2022 a patient underwent significant thoraco abdominal surgeries where four individual grafts were implanted (x1 gelweave trifurcate, x1 coselli, x1 gelweave straight and x1 gelsoft plus bifurcate).On (b)(6) 2022 infection was detected and it was indicated that the gelsoft plus bifurcate graft which was implanted is the cause as there are no signs of infection with the other three grafts implanted.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

Investigation findings: 3221 - no findings are available - the site performed culture testing of the alleged infection material from the implant site.Despite multiple requests for the findings of this analysis, teh results have not been communicated to vascutek ltd.; therefore it is impossible to determine a root cause.Investigation conclusions: 4315 - cause not established - vascutek ltd.Products are sterilised using 100% ethylene oxide which is a bactericidal chemical.The sterilisation process is fully validated ensuring a sterility assurance level (sal) of 10-6 using bacillus atrophaeus biological indicators.As no issues with the sterile barrier packaging was reported to us, this would indicate that when the graft was opened from its protective packaging, it was sterile.Unfortunately as the results of the culture testing performed by the site was not provided; it has not been possible to determine the type and modality of the reported infection; therefore no determination of root cause is possible.

Event Description

Event information updated from the initial report.On (b)(6) 2022, a patient had multiple grafts (x4) manufactured by vascutek ltd.Implanted (x3 gelweave branded devices & x1 gelsoft plus) in an extensive thoracoabdominal procedure.The site stated that all grafts were pre-soaked in rifampicin prior to implant.On 07 may 22 an incidental finding of infection was detected during an intervention procedure to arrest a bleeding issue.During the procedure all implanted grafts appeared to have a yellow coloured substance with a soft consistency on and around the grafts.This material was washed off the grafts, but the gelsoft bifurcate did not appear as clean as the others.The site indicated that it was believed that the gelsoft device may be the source.; though also indicated that the procedure itself may have been a factor.A sample of the yellow coloured substance was extracted and issued to the facility's laboratories for testing.

• Brand Name: GELSOFT PLUS
• Type of Device: GELSOFT PLUS BIFURCATE
• Manufacturer (Section D): VASCUTEK LTD; newmains avenue; inchinnan; glasgow, renrewshire PA49R R; UK PA49RR
• Manufacturer (Section G): VASCUTEK LTD; newmains avenue; inchinnan; glasgow, renrewshire PA49R R; UK PA49RR
• Manufacturer Contact: jason whittle ; newmains avenue; inchinnan; glasgow, renrewshire PA49R-R ; UK PA49RR
• MDR Report Key: 14630165
• MDR Text Key: 293520057
• Report Number: 9612515-2022-00006
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 05037881115566
• UDI-Public: 05037881115566
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K955230
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GELSOFT PLUS BIFURCATE
• Device Catalogue Number: 632412P-G
• Device Lot Number: 22233666
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/10/2022
• 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): Other
• Patient Sex: Male