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

Model Number	THP3032X150A
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Stroke/CVA (1770)
Date of Event	05/29/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturers narrative section h6 health effect - clinical code: 1770 stroke.On (b)(6) 2023, patient had left mca (middle cerebral artery) stroke.Patient was noted to have mixed aphasia and right hemiparesis.On (b)(6) 2023 patient experienced new onset of atrial fibrillation.Health impact - impact code: 4644 - medication required- treated with amiodarone bolus and cardioversion x2 amiodarone drop started.Medical device problem code: 3190 - insufficient information.2993 - adverse event without identified device or use problem.Component code: 4755 - part / component/sub-assembly term not applicable, the device does not have distinct parts, components, or subassemblies.Type of investigation: 4110 - trend analysis a similar event review was performed for stroke in thoraflex hybrid grafts between jan 18 and jun 23.(b)(4).No negative trend in the number of events was identified.No negative trend was identified 4111 - communication/interviews - further information has been requested from the site.3331- analysis of production records - a review of manufacturing and quality control records confirmed that the device was manufactured to the intended specifications investigation findings: 3233 - results pending completion of investigation.
Event or Problem Description
Event reported from extend post approval study as follows: thoraflex hybrid graft implanted on (b)(6) 2023.On (b)(6) 2023 patient had left mca (middle cerebral artery) stroke.Patient was noted to have mixed aphasia and right hemiparesis.On (b)(6) 2023 patient experienced new onset of atrial fibrillation requiring cardioversion, amiodarone drop started.Both events are unresolved and still getting treated.
Additional Manufacturer Narrative
Manufacturers narrative section h6 health effect - clinical code: 1770 - stroke -.On (b)(6) 2023 patient had left mca (middle cerebral artery) stroke - patient was noted to have mixed aphasia and right hemiparesis.On (b)(6) 2023 patient experienced new onset of atrial fibrillation health impact - impact code: 4644 - medication required- treated with amiodarone bolus and cardioversion x2 amiodarone drop started medical device problem code: 3190 - insufficient information - 2993 - adverse event without identified device or use problem component code: 4755 - part/component/sub-assembly term not applicable - the device does not have distinct parts, components, or subassemblies, type of investigation: 4110 - trend analysis a similar event review was performed for stroke in thoraflex hybrid grafts between jan 18 and jun 23.A similar event rate of 0.058% was confirmed.No negative trend in the number of events was identified.No negative trend was identified 4111 - communication/interviews - further information has been requested from the site.3331- analysis of production records - a review of manufacturing and quality control records confirmed that the device was manufactured to the intended specifications.Investigation findings: 3233 - results pending completion of investigation.
Event or Problem Description
This report has been submitted as follow up 1 for mfg.Report fda to provide correction to device details.
Additional Manufacturer Narrative
Manufacturers narrative section h6 health effect - clinical code: 1770 - stroke -.On (b)(6)patient had left mca (middle cerebral artery) stroke - patient was noted to have mixed aphasia and right hemiparesis.On (b)(6) 2023 patient experienced new onset of atrial fibrillation health impact - impact code: 4644 - medication required- treated with amiodarone bolus and cardioversion x2 amiodarone drop started medical device problem code: 3190 - insufficient information - 2993 - adverse event without identified device or use problem component code: 4755 - part/component/sub-assembly term not applicable - the device does not have distinct parts, components, or subassemblies, type of investigation: 4110 - trend analysis a similar event review was performed for stroke in thoraflex hybrid grafts between (b)(6).A similar event rate of 0.058% was confirmed.No negative trend in the number of events was identified.No negative trend was identified 4111 - communication/interviews - further information has been requested from the site.3331- analysis of production records - a review of manufacturing and quality control records confirmed that the device was manufactured to the intended specifications investigation findings: 213 - no device problem found - email from site on 24 july 23 confirmed, this was not a device related event.Investigation conclusion: 4310 - cause cannot be traced to device - email from site on 24 july 23 confirmed, this was not a device related event.
Event or Problem Description
This report has been submitted as a final for mfg.Report fda 9612515-2023-00005 to provide correction to device details.Update from site confrimed that this was not a device related event.

• Brand Name: THORAFLEX HYBRID
• Common Device Name: THORAFLEX HYBRID PLEXUS
• 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: 17207067
• Report Number: 9612515-2023-00005
• Device Sequence Number: 17809047
• Product Code: QSK
• UDI-Device Identifier: 05037881026824
• UDI-Public: 05037881026824
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P210006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study
• Initial Reporter Occupation: Physician
• Remedial Action: Patient Monitoring
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/28/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2024
• Device Model Number: THP3032X150A
• Device Catalogue Number: THP3032X150A-G
• Device Lot Number: 22326306
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/30/2023
• Supplement Date Received by Manufacturer: 05/30/2023; 05/30/2023
• Initial Report FDA Received Date: 06/27/2023
• Supplement Report FDA Received Date: 06/28/2023; 07/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/17/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 58 YR
• Patient Sex: Male