MAUDE Adverse Event Report: VASCUTEK LTD THORAFLEX HYBRID

Catalog Number THP3034X150J

Device Problem Material Twisted/Bent (2981)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/07/2023

Event Type  Injury  

Manufacturer Narrative

Clinical code: 4582 - no clinical signs, symptoms or conditions - no health damage at present.Impact code: 2199 - no health consequences or impact - no health damage at present.Medical device problem: 2981-material twisted/bent - graft was reported as kinked.Component code: 4755-part/component/sub-assembly term not applicable: type of investigation: 4114-device not returned: device remains implanted.4110-trend analysis: a 5-year review of similar complaints (appearance>>product.Defect>>curled/kinked/folds/twisted) gave an occurrence rate of (b)(4) (complaints v sales).4111 - communications/interviews - additional information has been requested from the site.

Event Description

As reported: kink: the patient was scheduled to undergo a thoracic stent grafting for a descending aortic aneurysm and an open stent grafting for an aortic arch aneurysm.On (b)(6) 2023, the thoracic stent grafting was performed for the descending aortic aneurysm.On 7 december, the open stent grafting was performed with the thoraflex hybrid for the aortic arch aneurysm.On 12 december, post-operative ct scan images were obtained.A kink in the stent graft section was suspected.Operation type: open stent grafting.

Event Description

As reported: kink: the patient was scheduled to undergo a thoracic stent grafting for a descending aortic aneurysm and an open stent grafting for an aortic arch aneurysm.On (b)(6) 2023, the thoracic stent grafting was performed for the descending aortic aneurysm.On 7 december, the open stent grafting was performed with the thoraflex hybrid for the aortic arch aneurysm.On 12 december, post-operative ct scan images were obtained.A kink in the stent graft section was suspected.Operation type: open stent grafting.

Manufacturer Narrative

Clinical code: 4582 - no clinical signs, symptoms or conditions - no health damage at present.Impact code: 2199 - no health consequences or impact - no health damage at present.Medical device problem: 2981-material twisted/bent - graft was reported as kinked.Component code: 4755-part/component/sub-assembly term not applicable: type of investigation: 4114-device not returned: device remains implanted.4110-trend analysis: a 5-year review of similar complaints (appearance>>product defect>>curled/kinked/folds/twisted) gave an occurrence rate of (b)(4) (complaints v sales).4111 - communications/interviews - additional information recieved from site: the site could not confirm if this event was related to the procedure or the device.They stated the event may have been related to both the procedure and the device as reported.No surgical intervention was necessary, and no additional treatment is planned.Blood flow through the lumen of the stent graft section was maintained.No health damage to the patient.3331- analysis of production records: full batch review was perfomred from finished prodict to raw material no issues found with product.Investigation findings: 213 - no device problem found: full batch review was perfomred from finished prodict to raw material no issues found with product.Investigation conclusion: 4315 - cause not established: due to the device not being made available for return, and the site stating that that this event may be related to both rocedure and device.The root cause for this event cannot be established.Updates to below sections: b1 updates from prodcut defect to adverse event: this is due to in investigation completed by manufacturer & full batch review was perfomred from finished prodict to raw material no issues found with product.H1 updates from malfunction tp serious injusry : this is due to in investigation completed by manufacturer & full batch review was perfomred from finished prodict to raw material no issues found with product.

• Brand Name: THORAFLEX HYBRID
• Type of Device: THORAFLEX HYBRID
• Manufacturer (Section D): VASCUTEK LTD; newmains avenue; inchinnan; glasgow, PA49R R; UK PA49RR
• Manufacturer (Section G): VASCUTEK LTD.; newmains avenue; inchinnan business park; glasgow,, renfrewshire PA4 9 RR,; UK PA4 9RR,
• Manufacturer Contact: jason whittle ; newmains avenue; inchinnan; glasgow, PA49R-R ; UK PA49RR
• MDR Report Key: 18343545
• MDR Text Key: 331076231
• Report Number: 9612515-2023-00037
• Device Sequence Number: 1
• Product Code: QSK
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P210006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Remedial Action: Patient Monitoring
• Type of Report: Initial,Followup
• Report Date: 01/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: THP3034X150J
• Device Lot Number: 25378753
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/07/2023
• 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