MAUDE Adverse Event Report: VASCUTEK LTD. THORAFLEX HYBRID PLEXUS

Model Number	N/A
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
During deployment, as physician was pulling on red clip to remove it from the delivery system, a piece of the red clip broke off and fell into the patients open chest.The surgeon stopped the procedure to explore the chest cavity, locate the piece of broken plastic and retrieve it.Thoraflex device deployed without further incident or negative impact on the patient or procedure.
Additional Manufacturer Narrative
Clinical code: 4582 - no clinical signs or symptoms or conditions: site confirmed within intake form, thoraflex device deployed without further incident or negative impact on the patient or procedure.Impact code: 2199 - no health consequences or impact: site confirmed within intake form, thoraflex device deployed without further incident or negative impact on the patient or procedure.4633 - surgical procedure delayed: site confirmed within intake form, the surgeon stopped the procedure to explore the chest cavity, locate the piece of broken plastic and retrieve it.Thoraflex device deployed without further incident or negative impact on the patient or procedure.Medical device problem code: 1261 - material fragmentation : site confirmed within intake form, during deployment, as physician was pulling on red clip to remove it from the delivery system, a piece of the red clip broke off and fell into the pt's open chest.Component code: 4755 - part/component/sub-assembly term not applicable type of investigation: 4110 - trend analysis: 4-year review was performed for thoraflex hybrid > endovascular issue > delivery system defect > other ( nature of event ) red clip, this gave an occurrence rate of (b)(4).No trend was identified requiring action at this time.4111 - communication/interview: additional information was received for this event on 21 apr 25 which confirmed the below: · there was no issues with the device before use.· no further issues with the device during implant.· no excessive force was used to deploy the device.· the patient is recovering within normal expectations.· the release clip was fully seated prior to use.· there was no damage (e.G.Cracks) observed on the clip or handle prior to use.· the release wire remained connected to the clip.Awaiting confiimation from site if the device will be returned.3331 - analysis of production record: to be performed.Investigation findings: 3233 - result pending completion of investigation conclusion: 11 - conclusion not yet available.
Additional Manufacturer Narrative
Clinical code: 4582 - no clinical signs or symptoms or conditions: site confirmed within intake form, thoraflex device deployed without further incident or negative impact on the patient or procedure.Impact code: 2199 - no health consequences or impact: site confirmed within intake form, thoraflex device deployed without further incident or negative impact on the patient or procedure.4633 - surgical procedure delayed: site confirmed within intake form, the surgeon stopped the procedure to explore the chest cavity, locate the piece of broken plastic and retrieve it.Thoraflex device deployed without further incident or negative impact on the patient or procedure.Medical device problem code: 1261 - material fragmentation : site confirmed within intake form, during deployment, as physician was pulling on red clip to remove it from the delivery system, a piece of the red clip broke off and fell into the pt's open chest.Component code: 4755 - part/component/sub-assembly term not applicable type of investigation: 4110 - trend analysis: 4-year review was performed for thoraflex hybrid > endovascular issue > delivery system defect > other ( nature of event ) red clip, this gave an occurrence rate of 0.000%.No trend was identified requiring action at this time.4111 - communication/interview: additional information was received for this event on 21 apr 25 which confirmed the below: there was no issues with the device before use.No further issues with the device during implant.No excessive force was used to deploy the device.The patient is recovering within normal expectations.The release clip was fully seated prior to use.There was no damage (e.G.Cracks) observed on the clip or handle prior to use.The release wire remained connected to the clip.3331 - analysis of production record: full batch review was performed from base fabric to finished product which confirmed the device was manufactured to specification with no issues identified.Investigation findings: 170 - manufacturing process problem identified - it is likely this failure was caused by the clip being significantly weakened by a void within the part at the point where the arm meets the crossmember of the clip.This void may have been caused by contamination of the mould cavity, or excessive heat applied to the mould tool during the moulding of this part.This is considered a low-risk failure as it does not prevent the device from being deployed, the affected grn had 5000 clips and all have been used with only one fail reported.Investigation conclusion: 4307 - cause traced to component failure- cause traced to the external manufacture of the release clip.
Event or Problem Description
During deployment, as physician was pulling on red clip to remove it from the delivery system, a piece of the red clip broke off and fell into the patient's open chest.The surgeon stopped the procedure to explore the chest cavity, locate the piece of broken plastic and retrieve it.Thoraflex device deployed without further incident or negative impact on the patient or procedure.This report is being submitted as a follow up #1 for manufacturing report number: 9612515-2025-00051 to provide event closure information for tag0223.

• Brand Name: THORAFLEX HYBRID PLEXUS
• Common Device Name: THORAFLEX HYBRID
• Manufacturer (Section D): VASCUTEK LTD.; newmains avenue; inchinnan buisness park; glasgow, renfrewshire PA4 9 RR; UK PA4 9RR
• Manufacturer (Section G): VASCUTEK LTD.; newmains avenue; inchinnan buisness park; glasgow, renfrewshire PA4 9 RR; UK PA4 9RR
• Manufacturer Contact: laura allan ; newmains avenue; inchinnan buisness park; glasgow, renfrewshire PA4 9-RR ; UK PA4 9RR
• MDR Report Key: 22008400
• Report Number: 9612515-2025-00051
• Device Sequence Number: 5229097
• Product Code: QSK
• UDI-Device Identifier: 05037881026749
• UDI-Public: 05037881026749
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Health Professional
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/11/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: THP3036X100A
• Device Lot Number: 25751583
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/17/2025
• Supplement Date Received by Manufacturer: 04/17/2025
• Initial Report FDA Received Date: 05/13/2025
• Supplement Report FDA Received Date: 07/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/07/2024
• 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 Sex: Unknown