MAUDE Adverse Event Report: VASCUTEK LTD GELWEAVE; GELWEAVE STRAIGHT

Model Number GELWEAVE STRAIGHT

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem Post Operative Wound Infection (2446)

Event Date 08/18/2020

Event Type  Injury  

Event 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.

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
• Type of Device: 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
• MDR Text Key: 297218927
• Report Number: 9612515-2022-00011
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 05037881105130
• UDI-Public: 05037881105130
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K952293
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 07/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/05/2019
• 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): Hospitalization; Required Intervention
• Patient Age: 67 YR
• Patient Sex: Male