MAUDE Adverse Event Report: VASCUTEK LTD. GELWEAVE; GELWEAVE ANTE-FLO

Model Number GELWEAVE ANTE-FLO

Device Problems Material Perforation (2205); Material Integrity Problem (2978)

Patient Problem Cardiac Tamponade (2226)

Event Date 12/21/2020

Event Type  Injury  

Manufacturer Narrative

Only sex and age was provided for patient information: no d.O.B.Provided.(b)(4).Type of investigation: testing of actual device, the graft or a section of the graft has been returned for investigation however results of investigation are not available at this time.(b)(4).No analysis of production records has not been performed at this time - vascutek has only just received the serial number to trace this batch manufactured in 2010.The batch history record is stored off site and request for this to be returned has been made.Investigation and collection of further information is ongoing and will be reported in next follow up / final report.

Event Description

Event reported to vascutek ltd.As follows: blood leakage: cardiac tamponade was noted in the thoracic cavity.The patient underwent drainage and thoracotomy.At that time, blood was leaking from the reference line of the one branch implanted in 2014.In the end, the graft was replaced with a triplex advanced 1 branch graft.The procedure was successfully completed.Operation type: ascending aorta replacement.

Event Description

Event reported to vascutek ltd.As follows: blood leakage: cardiac tamponade was noted in the thoracic cavity.The patient underwent drainage and thoracotomy.At that time, blood was leaking from the reference line of the one branch implanted in 2014.In the end, the graft was replaced with a triplex advanced 1 branch graft.The procedure was successfully completed.Operation type: ascending aorta replacement.

Manufacturer Narrative

Manufacturing narrative.Section a only sex and age was provided for patient information - no d.O.B.Provided.Section d6 - only year of implant provided -2014 section h6 health effect - clinical code - 2226 - cardiac tamponade - patient presented with cardiac tamponade, it is unknown if the leakage seen was a contributing factor to this event.Health effect - impact code code - 4624 - surgical intervention - intervention was performed for cardiac tamponade and leakage was seen on the graft implanted in 2014 code - 4627 - device explanation - the device implanted in 2014 was explanted due to leakage seen code - 4629 - device revision or replacement - the explanted device was removed and replace with a similar branched device.Medical device problem code code - 2978 - material integrity problem code - 2205 - material perforation - it was reported that the graft was leaking along reference line of the branch of the graft - it is unclear if the leakage seen was from a hole in the device or blushing along this area.Component code - 4755 - part/component/sub-assembly code not applicable - the graft is manufactured from two continuous woven tubes of material - body and branch which are then sewn together type of investigation code - 10 - testing of actual device - a section of the graft was returned on 18-jan-2021 for investigation code - 4109 - historical data analysis - a 5-year review of similar events for gelweave leakage was performed and gave an occurrence rate of 0.008%(complaints v sales) code - 3331 - a review of qc, manufacturing and physical testing of base material records were retrieved and reviewed.No issue was found with manufacture of batch and all physical testing with respect to porosity testing met acceptance citeria, code - 4111 - communication/interviews - vascutek requested further information on event relationship to device and for further information on initial implantation of device.- further information and video of the event were recieved investigation findings code - 213 - no device problem found - no issue was found on investigation of the structure of the graft that could have led to the bleeding seen.See evaluation report for further information.Conclusion code - 4315 -cause not established - no root cause for the leakage could be determined from the investigation of the batch history of the device or from the investigation into the returned sample.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: GELWEAVE ANTE-FLO
• Manufacturer (Section D): VASCUTEK LTD.; newmains avenue; inchinnan business park; renfrewshire, PA4 9 RR; UK PA4 9RR
• MDR Report Key: 11184453
• MDR Text Key: 233950256
• Report Number: 9612515-2021-00004
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• PMA/PMN Number: K040829
• 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: 02/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2015
• Device Model Number: GELWEAVE ANTE-FLO
• Device Catalogue Number: 734026/10
• Device Lot Number: 114144
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2021
• Date Manufacturer Received: 12/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 43 YR