MAUDE Adverse Event Report: VASCUTEK LTD. THORAFLEX HYBRID

Model Number UNKNOWN

Device Problem Material Twisted/Bent (2981)

Patient Problems Insufficient Information (4580); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 10/13/2023

Event Type  Injury  

Manufacturer Narrative

Manufacturers narrative: clinical code: 4580 - insufficient information: additional information requested from site a/w feedback impact code: 4648 - insufficient information: additional information requested from site a/w feedback medical device problem: 2981- material twisted/bent: the stent-graft section was kinked at 3rd and 4th stents.Component code: 4755 - part/component/sub-assembly term not applicable type of investigation: 4110 - trend analysis: a similar event review was performed for appearance > product defect > curled / kinked / folds / twisted events in thoraflex hybrid grafts between jan 18 and jan 24.A similar event rate of 0.037% was confirmed.No negative trend was identified.4111 - communication/ interview: additional information requested from site a/w feedback 3331- analysis of production records: a review of manufacturing and quality records was carried out no issues found.4114 - device not returned: device remains implanted.

Event Description

"stenosis in stent graft section: the thoraflex hybrid was implanted in the patient with the thoracic aortic aneurysm.Post-operative ct scan revealed stenosis in the stent graft section placed in the aortic curvature due to a kink at the third and fourth stents from the proximal side.Although the stent graft section is stenotic, there was no difference in blood pressure between the upper and lower limbs, so additional tevar will be performed as needed if the situation changes.The stent-graft section was kinked at 3rd and 4th stents." operation type: aortic ach replacement with osg no ancillary device no blood loss.

Event Description

"stenosis in stent graft section: the thoraflex hybrid was implanted in the patient with the thoracic aortic aneurysm.Post-operative ct scan revealed stenosis in the stent graft section placed in the aortic curvature due to a kink at the third and fourth stents from the proximal side.Although the stent graft section is stenotic, there was no difference in blood pressure between the upper and lower limbs, so additional tevar will be performed as needed if the situation changes.The stent-graft section was kinked at 3rd and 4th stents." operation type: aortic ach replacement with osg no ancillary device no blood loss.This report has been submitted as a final for mfg.Report fda 9612515-2024-00001 to provide correction to device details.

Manufacturer Narrative

Manufacturers narrative: clinical code: 4581 - appropriate clinical signs, symptoms, conditions term / code not available: the site confirmed there was no problems with patient outcome.Impact code: 2199- no health consequences or impact: the site confirmed there was no problems with patient outcome.Medical device problem: 2981- material twisted/bent: the stent-graft section was kinked at 3rd and 4th stents.Component code: 4755 - part/component/sub-assembly term not applicable.Type of investigation: 4110 - trend analysis: a similar event review was performed for appearance > product defect > curled / kinked / folds / twisted events in thoraflex hybrid grafts between (b)(6) and (b)(6).A similar event rate of 0.037% was confirmed.No negative trend was identified.4111 - communication/ interview: the site confirmed the graft was cut using a cautery and there was no issue with graft before implant.There was a mild calcification of the artery (general level), there was no particulates on the inner or outer surfaces of the graft.There was also nothing to note on the manipulation of the graft for this type of procedure.The device was sealed distally without extension and the sealing diameter was 30.8mm.3331- analysis of production records: full batch review was performed as showed no issues with the device during manufacturing from raw material to finished product.4114 - device not returned: device remains implanted.Investigation findings: 3221 - no findings available: from the investigation completed, information received and no return of the device or scans for review.The outcome of the event could not be determined.Investigation conclusion: 4315 - cause not established: from the investigation completed, information received and no return of the device or scans for review.The outcome of the event could not be determined.Update to clinical code and impact code from information received from site.

• Brand Name: THORAFLEX HYBRID
• Type of Device: THORAFLEX HYBRID
• Manufacturer (Section D): VASCUTEK LTD.; newmains avenue; inchinnan business park; glasgow,, renfrewshire PA4 9 RR,; UK PA4 9RR,
• Manufacturer (Section G): VASCUTEK LTD; newmains avenue; inchinnan; glasgow, PA49R R; UK PA49RR
• Manufacturer Contact: jason whittle ; newmains avenue; inchinnan; glasgow, PA49R-R ; UK PA49RR
• MDR Report Key: 18482122
• MDR Text Key: 332491100
• Report Number: 9612515-2024-00001
• 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: 01/31/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/30/2024
• Device Model Number: UNKNOWN
• Device Catalogue Number: THP3032X100J
• Device Lot Number: 25326204
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/24/2023
• 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