MAUDE Adverse Event Report: VASCUTEK LTD THORAFLEX HYBRID PLEXUS

Catalog Number	THP3032X100A
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Pericardial Effusion (3271)
Date of Event	05/09/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
This event was reported as part of the extend-001 clinical study (b)(6).Patient's initial thoraflex hybrid implant took place on (b)(6) 2025.On (b)(6) 2025 patient underwent an extension procedure with relaypronbs and gore viabahn endoprosthesis.During the extension procedure the patient had an adverse event of pericardial effusion.The site provided the following narrative: "moderate to large pericardial effusion seen during extension implant, drained intra-operatively and mediastinal drain placed.Drain removed 5/13." procedure carried out as a result of the event was intra-operative drainage of the pericardial effusion.
Additional Manufacturer Narrative
Health effect - clinical code (e).3271 - pericardial effusion.Health effect - impact code (f).4630 - modified surgical procedure: intra-operative drainage of the pericardial effusion was performed.Medical device problem code (a).3190 - insufficient information: an adverse event appears to have occurred but there is not yet enough information available to classify the device problem.Component code (g) 4755 - part/component/sub-assembly term not applicable.Type of investigation (b) 4110 - trend analysis: a review of similar events (thoraflex hybrid pericardial effusion.Events jan 21 - may 25 vs thoraflex hybrid sales jan 21 - may 25) gave an occurrence rating of <0.001%.No trend requiring action was identified at this time.4111 - communication / interviews: additional questions on this event have been delivered to the complainant to assist with this investigation.3331 - analysis of production records: a full batch review from raw material to finished product shall be performed to determine if there is any issues with the manufacture of the device.4117 - device not accessible for testing: device remains implanted.Investigation findings (c) 3233 - results pending completion of investigation.Investigation conclusions (d) 11 - conclusion not yet available.
Additional Manufacturer Narrative
Health effect - clinical code (e) 3271 - pericardial effusion.Health effect - impact code (f) 4630 - modified surgical procedure: intra-operative drainage of the pericardial effusion was performed.Medical device problem code (a) 2993 - adverse event without identified device or use problem: complainant reported that the adverse event was not due to a device failure or deficiency.Component code (g) 4755 - part/component/sub-assembly term not applicable.Type of investigation (b) 4110 - trend analysis: a review of similar events (thoraflex hybrid pericardial effusion events (b)(6) 2021 - (b)(6) 2025 vs thoraflex hybrid sales (b)(6) 2021 - (b)(6) 2025) gave an occurrence rating of (b)(4).No trend requiring action was identified at this time.4111 - communication / interviews: complainant has confirmed that prophylactic antibiotics (cefazolin) was administered to the patient.The fluid from the pericardial effusion was also noted to be residual blood but was not tested.3331 - analysis of production records: a full batch review from raw material to finished product shall be performed to determine if there is any issues with the manufacture of the device.4117 - device not accessible for testing: device remains implanted.4112 - analysis of information provided by user/ third party: a review of patient scans was able to confirm the presence of the pericardial effusion, however the device relationship to the reported adverse event of pericardial effusion cannot be determined from the imaging.Investigation findings (c) 213 - no device problem found: early pericardial effusion (occurring within 1 week of surgery) was reviewed via clinical literature and it was determined that the most likely causes were: 1) inflammatory reaction to surgery inflammation arising from trauma of the implantation of the thoraflex hybrid device could result in a buildup of fluid around the heart.However, it was determined that the fluid was residual blood rather than a clear exudate.The fluid was not tested however; it was most likely considered to be residual blood due to colouration.2) bleeding or oozing into pericardial space as the fluid in the pericardial space was determined to be [?]residual blood', oozing or bleeding via an endoleak or hole could have caused the pericardial effusion.Whilst there is a large entry tear distal to the relay device as determined by review of the patient scans, there is no evidence of this tear contributing to the pericardial effusion, as the event was determined to be present during the implantation of the relay device.3) infection infectious pericarditis, especially bacterial can occur post-surgery as a secondary complication.Literature emphasizes pps and bleeding as primary drivers, infection accounts for a smaller proportion of cases.No infection was reported by the complainant; however the patient was treated with cefazolin, recovering from the event after the course of antibiotic was completed.No definitive evidence of a relationship between an infection and the event can be proven.4) drug use the patient has concomitant medications including heparin and clopidogrel.Both of which can lead to an increased risk of pericardial effusion.No potential device related causes were determined.Investigation conclusions (d) 4310 - cause traced to non-device related factors: as pericardial effusion is a well-known complication following cardiac surgery, and the complainant has stated that the there is no known device deficiency or failure.This event has been determined to be an expected and undesirable side effect.
Event or Problem Description
This event was reported as part of the extend-001 clinical study (b)(4).Patient's initial thoraflex hybrid implant took place on (b)(6) 2025.On (b)(6) 2025 patient underwent an extension procedure with relaypronbs and gore viabahn endoprosthesis.During the extension procedure the patient had an adverse event of pericardial effusion.The site provided the following narrative: "moderate to large pericardial effusion seen during extension implant, drained intra-operatively and mediastinal drain placed.Drain removed 5/13." procedure carried out as a result of the event was intra-operative drainage of the pericardial effusion.This report is being submitted as follow up #1 for manufacturing report number 9612515-2025-00066 to provide event closure information for tag0264.

• Brand Name: THORAFLEX HYBRID PLEXUS
• Common Device Name: THORAFLEX HYBRID
• Manufacturer (Section D): VASCUTEK LTD; newmains avenue; inchinnan buiness park; renfrewshire, glasgow PA49R R; UK PA49RR
• Manufacturer (Section G): VASCUTEK LTD; newmains avenue; inchinnan buiness park; renfrewshire, glasgow PA49R R; UK PA49RR
• Manufacturer Contact: laura allan ; newmains avenue; inchinnan buiness park; renfrewshire, glasgow PA49R-R ; UK PA49RR
• MDR Report Key: 22468398
• Report Number: 9612515-2025-00066
• Device Sequence Number: 17168022
• Product Code: QSK
• UDI-Device Identifier: 05037881026725
• UDI-Public: 05037881026725
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: P210006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional
• Initial Reporter Occupation: Physician
• Remedial Action: Modification/Adjustment
• Type of Report: Initial,Followup
• Report Date (Section B): 09/09/2025

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 Catalogue Number: THP3032X100A
• Device Lot Number: 25466086
• 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: 06/12/2025
• Supplement Date Received by Manufacturer: 06/12/2025
• Initial Report FDA Received Date: 07/10/2025
• Supplement Report FDA Received Date: 09/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/31/2023
• 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: 53 YR
• Patient Sex: Male