MAUDE Adverse Event Report: VASCUTEK LTD THORAFLEX HYBRID PLEXUS

Model Number	N/A
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Ruptured Aneurysm (4436)
Date of Event	07/29/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The indication for surgery was an aortic aneurysm and dissection with a type 2 endoleak in the descending thoracic aorta.Shape of the aneurysm and debakey type.An elective thoraflex hybrid plexus was performed on (b)(6) 2024.The ascending aortic graft from the previous surgery was then trimmed, and the proximal thoraflex graft (30mm) trimmed and bevelled to fit this.At the post index procedure assessment the graft was patent with no thoraflex hybrid device deformations.On the (b)(6) 2024, 6 days post index procedure, a computed tomography angiography scan was performed which showed a leaking thoracoabdominal aortic aneurysm (taaa).The patient was examined by cardiovascular surgeon and deemed a candidate for emergency endovascular taaa repair using parallel endografts.Surgery was performed -tevar with parallel grafts for celiac, spinal muscular atrophy, and left renal via right femoral and left common carotid cutdowns.The site have deemed this to be an unanticipated event, which is not related to the procedure or the device but related to a pre-existing condition.The medical monitor who oversees the safety of the study has deemed this event to be possibly related to the device patient outcome: the patient recovered from this event on 29 jul 24 and the patient remains on the study.
Additional Manufacturer Narrative
Clinical code: 4436- ruptured aneurysm: on the 29 jul 24, 6 days post index procedure, a computed tomography angiography scan was performed which showed a leaking thoracoabdominal aortic aneurysm (taaa).Impact code: 4625 - additional surgery: an elective thoraflex hybrid plexus was performed on (b)(6) 2024.The ascending aortic graft from the previous surgery was then trimmed, and the proximal thoraflex graft (30mm) trimmed and bevelled to fit this.Surgery was performed -tevar with parallel grafts for celiac, spinal muscular atrophy, and left renal via right femoral and left common carotid cutdowns.4642- additional device required: the patient was examined by cardiovascular surgeon and deemed a candidate for emergency endovascular taaa repair using parallel endografts.Device problem code: 3190 - insufficient information: awaiting further information from the site component code: 4755 - part/component/sub-assembly term not applicable type of investigation: 4110- trend analysis: thoraflex hybrid sales jan 21 - jun 24 vs medical event > aneurysm (leakage) jan 21 - aug 24 gave an occurrence of less than 0.001%.There was no trend observed.3331- analysis of production records: a review of manufacturing and qc records confirmed that there were no issues with the manufacture of the device.4111 - communication/interview: awaiting further information from the site 4117 - device not accessible for testing: device remains implanted.Investigation findings: 3233 - results pending completion of investigation conclusion: 11 - cause not yet established.
Additional Manufacturer Narrative
Clinical code: 4436- ruptured aneurysm: on the (b)(6) 2024, 6 days post index procedure, a computed tomography angiography scan was performed which showed a leaking thoracoabdominal aortic aneurysm (taaa).Impact code: 4625 - additional surgery: thoracic endovascular aortic repair (tevar) with parallel grafts for celiac, spinal muscular atrophy, and left renal via right femoral and left common carotid cutdowns.4642- additional device required: the patient was examined by cardiovascular surgeon and deemed a candidate for emergency endovascular taaa repair using parallel endografts.Device problem code: 2993: adverse event without identified device or use problem- it was confirmed on (b)(6) 2024 the rupture was at the distal end of an old stent.Aneurysm leakage was not related to thoraflex hybrid.Component code: 4755 - part/component/sub-assembly term not applicable.Type of investigation: 4110- trend analysis: thoraflex hybrid sales (b)(6) 2021 - (b)(6) 2024 vs medical event > aneurysm (leakage) (b)(6) 2021 - (b)(6) 2024 gave an occurrence of less than (b)(4).There was no trend observed.3331- analysis of production records: a full batch review was performed for batch id: 25153968, and no issues were identified during manufacturing process from raw materials to finished products.4111 - communication/interview: on (b)(6) 2024 it was confirmed aneurysm leakage was not related to thoraflex hybrid but related to an old non-terumo stent.4117 - device not accessible for testing: device remains implanted.Investigation findings: 213: no device problem found- not device related.Investigation conclusion: 40 - cause traced to another device: aneurysm leakage was related to an old stent and not related to thoraflex hybrid.
Event or Problem Description
Clinical trial extend-(b)(4), site no.(b)(4), patient no.(b)(6).The indication for surgery was an aortic aneurysm and dissection with a type 2 endoleak in the descending thoracic aorta.Shape of the aneurysm and debakey type.An elective thoraflex hybrid plexus was performed on (b)(6) 2024.The ascending aortic graft from the previous surgery was then trimmed, and the proximal thoraflex graft (30mm) trimmed and bevelled to fit this.At the post index procedure assessment the graft was patent with no thoraflex hybrid device deformations.On the (b)(6) 2024, 6 days post index procedure, a computed tomography angiography scan was performed which showed a leaking thoracoabdominal aortic aneurysm (taaa).The patient was examined by cardiovascular surgeon and deemed a candidate for emergency endovascular taaa repair using parallel endografts.Surgery was performed - thoracic endovascular aortic repair (tevar) with parallel grafts for celiac, spinal muscular atrophy, and left renal via right femoral and left common carotid cutdowns.The site have deemed this to be an unanticipated event, which is not related to the procedure or the device but related to a pre-existing condition.The medical monitor who oversees the safety of the study has deemed this event to be possibly related to the device patient outcome: the patient recovered from this event on 20(b)(6)24 and the patient remains on the study.This report is being submitted as a initial/ final for mfg report number 9612515-2024-00063 to provide event closure information for (b)(4).

• Brand Name: THORAFLEX HYBRID PLEXUS
• Common Device Name: THORAFLEX HYBRID
• Manufacturer (Section D): VASCUTEK LTD; newmains avenue; inchinnan; glasgow, PA49R R; UK PA49RR
• Manufacturer (Section G): VASCUTEK LTD; newmains avenue; inchinnan; glasgow, PA49R R; UK PA49RR
• Manufacturer Contact: laura allan ; newmains avenue; inchinnan; glasgow, PA49R-R ; UK PA49RR
• MDR Report Key: 20146488
• Report Number: 9612515-2024-00063
• Device Sequence Number: 8301355
• Product Code: QSK
• UDI-Device Identifier: 05037881026855
• UDI-Public: 05037881026855
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P210006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study
• Initial Reporter Occupation: Physician
• Remedial Action: Repair
• Type of Report: Initial,Followup
• Report Date (Section B): 10/08/2024

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 Model Number: N/A
• Device Catalogue Number: THP3038X150A-G
• Device Lot Number: 25153968
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2024
• Supplement Date Received by Manufacturer: 08/08/2024
• Initial Report FDA Received Date: 09/05/2024
• Supplement Report FDA Received Date: 10/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/14/2022
• 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: Required Intervention
• Patient Age: 66 YR
• Patient Sex: Male