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

Model Number GELWEAVE

Device Problems Use of Device Problem (1670); Material Perforation (2205); Material Integrity Problem (2978); Device Handling Problem (3265)

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

Event Date 05/30/2019

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).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 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.Vascutek ltd.Has requested further information from the site on how graft was treated prior to and during procedure and if all ifu recommendations were followed.No further information has been received at time of submission of this report.If further information is received vascutek ltd.Will report findings in next follow up / final report.

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.

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.

Manufacturer Narrative

Section h6: patient code - 2692 -no known impact or consequence to patient: 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.Device code - 1670 - use of device problem - further information received on 17-jul-19 indicated that the device was not rinsed in saline for 5 minutes prior to use.Device code - 3265 - device handling problem - ifu states that failure to rinse for 5 minutes could lead to the graft being more susceptible to leakage when implanted.Method code - 4109 - historical data analysis: 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.Method code - 3331 - analysis of production records: 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.Method code - 4117 - device not accessible for testing: device remains implanted in patient and will not be returned for testing.Results code - 213 - no device problem found: review of product batch records showed no issue with the manufacture of this batch.Conclusion code - 19 - caused traced to user - 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.

• 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
• MDR Report Key: 8762093
• MDR Text Key: 198343697
• Report Number: 9612515-2019-00015
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 05037881106373
• UDI-Public: 05037881106373
• Combination Product (y/n): N
• PMA/PMN Number: K090987
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/06/2019,08/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2021
• Device Model Number: GELWEAVE
• Device Catalogue Number: 73341088/8
• Device Lot Number: 388421
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/30/2019
• Device Age: 34 MO
• Event Location: Hospital
• Date Report to Manufacturer: 06/06/2019
• Date Manufacturer Received: 06/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 52 YR