MAUDE Adverse Event Report: VASCUTEK LTD GELWEAVE; GELWEAVE STRAIGHT

Model Number GELWEAVE STRAIGHT

Device Problem Material Integrity Problem (2978)

Patient Problem Blood Loss (2597)

Event Date 01/28/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Bleeding was reported through the graft material.A review of qc, manufacturing and physical test records was performed and showed that batch was manufactured to design specification.All released grafts from batch also met acceptance criteria for all physical tests on base material and in process testing.A five-year review (jan 15 - feb 20) of similar events was performed for graft leakage (oozing) related events.A similar event rate of 0.015% (rate=complaints v sales) was confirmed for all gelweave variants.There have been no similar complaints received from other units from this batch and no negative trend has been identified.Actual device remains implanted, therefore no testing could be performed.Review of product batch records showed no issue with the manufacture of this batch.From the information received, users failure to rinse the device for 5 mins prior to the procedure may have contributed to the leakage seen.Vascutek ltd, now considers this complaint closed.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.

Event Description

During a procedure to implant a gelweave straight graft on (b)(6) 2020, the surgeon reported a localised blood leak (oozing) from the body of the graft.It is not known how the leak was arrested but the procedure was completed, and the patient was reported as stable.

• Brand Name: GELWEAVE
• Type of Device: GELWEAVE STRAIGHT
• Manufacturer (Section D): VASCUTEK LTD; newmains avenue; inchinnan business park; renfrewshire, PA4 9 RR; UK PA4 9RR
• Manufacturer (Section G): VASCUTEK LTD; newmains avenue; inchinnan business park; renfrewshire, PA4 9 RR; UK PA4 9RR
• Manufacturer Contact: jason whittle ; newmains avenue; inchinnan business park; renfrewshire, PA4 9-RR ; UK PA4 9RR
• MDR Report Key: 9816903
• MDR Text Key: 206139680
• Report Number: 9612515-2020-00002
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: TH
• PMA/PMN Number: K952293
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/27/2020,03/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2020
• Is this an Adverse Event Report?: No
• 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
• Device Lot Number: 17833976
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/28/2020
• Device Age: 8 MO
• Event Location: Hospital
• Date Report to Manufacturer: 02/27/2020
• Date Manufacturer Received: 02/27/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/31/2019
• 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): Other
• Patient Age: 53 YR