MAUDE Adverse Event Report: VASCUTEK LTD GELWEAVE; 4 BRANCH PLEXUS

Model Number GELWEAVE

Device Problems Use of Device Problem (1670); Device Handling Problem (3265)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/24/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).No reported significant delay to procedure, patient consequence or harm.Blushing/bleeding was repaired with application of bioglue and patient reported as stable post op.(b)(4).Information from the customer indicated that the device was not rinsed in saline for 5 minutes prior to use.(b)(4).Ifu states that failure to rinse for 5 minutes could lead to the graft being more susceptible to leakage when implanted.A 5-year review of previous complaints was carried out and gave an occurrence rate of (b)(4) (complaints v sales) across all gelweave products and leakage types and (b)(4) (complaints v sales) for blushing only.Review of retained qc, manufacturing and physical testing records performed: a review of retained qc and manufacturing records showed that this batch was manufactured to specification with no issues raised.A review of the graft base material physical tests showed all testing met acceptance criteria.Base material porosity tests and finished product porosity tests were all within specification with no issues highlighted.Device not accessible for testing: device remains implanted in patient and will not be returned for testing.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 as stated in gelsoft plus ifu 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.

Event Description

Event was reported to vascutek ltd.As follows: oozing blood from the graft at aortic arch.Short video was provided showing heavy blushing of the graft between proximal anastamosis, and branches of arch.There is little or no bleeding from the remaining arch, or branches of the device.

• Brand Name: GELWEAVE
• Type of Device: 4 BRANCH PLEXUS
• 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: 8887595
• MDR Text Key: 218194188
• Report Number: 9612515-2019-00023
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 05037881106366
• UDI-Public: 05037881106366
• Combination Product (y/n): N
• Reporter Country Code: TH
• PMA/PMN Number: K090987
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/25/2019,08/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2021
• Device Model Number: GELWEAVE
• Device Catalogue Number: 73321088/8
• Device Lot Number: 17345314 1044
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Device Age: 16 MO
• Event Location: Hospital
• Date Report to Manufacturer: 07/25/2019
• Initial Date Manufacturer Received: 07/25/2019
• Initial Date FDA Received: 08/13/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/27/2018
• 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): Required Intervention