MAUDE Adverse Event Report: VASCUTEK LTD. THORAFLEX HYBRID; THORAFLEX HYBRID PLEXUS

Catalog Number THP3036X100B-G

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Insufficient Information (4580)

Event Date 08/05/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Historical data analysis - a five year review of similar reported events of endoleak type i in thoraflex hybrid branded grafts was completed, an occurrence rate of 0.094% was confirmed.No negative trend in the number of events reported was identified.Trend analysis - no negative trend was identified.Communication / interviews - further information - scans have been requested from the site.Device not available for testing - device remains in situ.Analysis of production records - the review of quality, manufacturing and physical test records showed that the device was manufactured to the intended specifications.No issue has been found upon review of the retained device history records for this device conclusion is not yet available - additional information and ct scans has been requested from the study site.

Event Description

Event reported via thor study as type 1b endoleak distal end of stent graft.The severity of the event has been reported as mild, and the outcome as unresolved.An endovascular stent extension is planned.While the site have entered this event as unanticipated, endoleaks are anticipated per protocol.

Manufacturer Narrative

Investigation findings: 213 - no device problem found.- retained manufacturing records were reviewed and showed the device was manufactured to specification, on (b)(6) 2022 ct scans were received and reviewed.The conclusion from the review is as follows: the thoraflex hybrid device did not create a distal seal due to insufficient oversizing of the device.The device was also not extended distally to obtain a distal seal, resulting in a type 1b endoleak and increased dilatation of the descending aorta.The review of the scans confirmed that the diameter for the distal ring of the device is 36.5mm.That verifies that the device sizing listed on the label matches the device that was used.Investigation conclusion: 18 - the root cause of the event was determined to be procedure not followed.Thoraflex hybrid ifu provides instructions on what size of the device should be chosen depending on the size of the dissection (301-192_1 thoraflex hybrid gen2 set a, section 2 pages 9 and 10).

Event Description

This report is being submitted as follow up #1 for mfg.Report# 9612515-2022-00014 comp (b)(4)to provide event closure information and updated device details.

• Brand Name: THORAFLEX HYBRID
• Type of Device: THORAFLEX HYBRID 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; glasgow, renfrewshire PA4 9-RR ; UK PA4 9RR
• MDR Report Key: 15491844
• MDR Text Key: 300652170
• Report Number: 9612515-2022-00014
• Device Sequence Number: 1
• Product Code: QSK
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K090987
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2020
• Device Catalogue Number: THP3036X100B-G
• Device Lot Number: 17606685
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/01/2022
• Initial Date FDA Received: 09/27/2022
• Supplement Dates Manufacturer Received: 09/01/2022
• Supplement Dates FDA Received: 11/29/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/07/2018
• 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
• Patient Age: 78 YR
• Patient Sex: Male