MAUDE Adverse Event Report: VASCUTEK LTD GELWEAVE; GELWEAVE STRAIGHT

Model Number	GELWEAVE STRAIGHT
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	Post Operative Wound Infection (2446)
Date of Event	08/18/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
This event was reported via the panther study programme as follows: a gelweave straight graft was utilised as part of an ecmo procedure (ecmo cannulation) on (b)(6) 2020.On (b)(6) 2020 a festering wound infection was reported.On (b)(6) 2020 the gelweave graft was explanted.The event was indicated as device, patient and procedure related.
Additional Manufacturer Narrative
(b)(4).Type of investigation: historical data analysis - a five-year review of similar reported events of graft infection relating to gelweave branded grafts was completed, an occurrence rate of 0.001% was confirmed.No similar events have been reported from the remainder of the batch.Trend analysis - no negative trend was identified.Communication/interviews - further information / biopsy results was provided - klebsiella pneumoniae, enterobacter clocae, klebsiella oxytoca, staphylococcus epidermidis was detected.Device not accessible for testing - the graft was explanted and is not available.Analysis of production records - qc, manufacturing sterilisation and physical test records were retrieved and reviewed; they indicate that the batch was manufactured to specification and all tests met acceptance criteria.Specific review of the bacteria found indicates that they are common to wound site infections.Vascutek ltd.'s onsite environmental / clean-room monitoring and bioburden testing has never detected klebsiella pneumoniae, enterobacter clocae or klebsiella oxytoca.Staphylococcus epidermidis is a bacteria that has been previously detected within our processes but we have shown through sub-lethal sterilisation validation that this organism would not survive our sterilisation process.Investigation findings: no device problem found - no issue has been found upon review of the retained device history records for this device/batch.The source of this type of contamination has not come from the device.Investigation conclusions: cause not established - the device was manufactured to specifications.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.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: GELWEAVE
• Common Device Name: GELWEAVE STRAIGHT
• 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: 15162582
• Report Number: 9612515-2022-00011
• Device Sequence Number: 15103011
• Product Code: DSY
• UDI-Device Identifier: 05037881105130
• UDI-Public: 05037881105130
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K952293
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/04/2022

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2022
• Device Model Number: GELWEAVE STRAIGHT
• Device Catalogue Number: 733008-G
• Device Lot Number: 17816443
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/13/2022
• Initial Report FDA Received Date: 08/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/05/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 67 YR
• Patient Sex: Male