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	Kidney injury (4882)
Date of Event	03/04/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
On post-operative day 1, site reported an adverse event of acute kidney injury' - with further details stating nephrology consulted.The event was considered ]unresolved, still treating' at time of report.The patient continued in the study.Concomitant medications taken at the time of the event include aspirin, clonidine, metoprolol tartrate, nifedipine, heparin and protamine.
Additional Manufacturer Narrative
Clinical code: 4882 - kidney injury: the site reported an adverse event (ae) of [?]acute kidney injury' impact code 4648 - insufficient information.Medical device code: 3190 - insufficient information.Component code: 4755 - part/ component/ sub-assembly term not applicable.Type of investigation: 4110 - trend analysis: (b)(4).Investigation findings: 3233 - result pending completion of investigation.Investigation conclusion: 11 - conclusion not yet available.
Event or Problem Description
Event was reported by clinical study: extend - (b)(4).On post-operative day 1, site reported an adverse event of acute kidney injury' - with further details stating nephrology consulted.The event was considered] unresolved, still treating' at time of report.The patient continued in the study.Concomitant medications taken at the time of the event include aspirin, clonidine, metoprolol tartrate, nifedipine, heparin and protamine.This report is being submitted as follow up #2 for manufacturing report number 9612515-2025-00028 to provide event closure information for tag0184.Report sent date updated in section b4.
Additional Manufacturer Narrative
Clinical code: 4882 - kidney injury: the site reported an adverse event (ae) of acute kidney injury' impact code: 4644 - medication required : the patient was not anticoagulated preoperatively, except for their aspirin that was normally prescribed.Postoperatively, the patients received enoxaparin and warfarin.Medical device code: 2993 - adverse event without identified device or use problem: scan review was not performed as sme (subject matter expert) confirmed that, the event of acute kidney injury will not be visible on the scan as this has been determined by blood tests.The implantation of a thoraflex hybrid device does not require any surgical access in the abdomen, so can't see how the event can be considered to be device related.Component code: 4755 - part/ component/ sub-assembly term not applicable.Type of investigation: 4110 - trend analysis: 4-year review was performed; occurrence rate was 0.000%.No trend identified at this time.3331 - analysis of production records: comprehensive batch review had been performed; no issue were identified during manufacture of this device.Device manufactured to specification.4117 - device not accessible for testing: device remains implanted.4111 - communication/interview: additional information was received on 25 mar 2025 which confirmed: · the patient outcome is currently that the patient is getting repeat kidney function labs next week.· there were no scans or ultrasounds for the kidneys completed.· the patient was not anticoagulated preoperatively, except for their aspirin that was normally prescribed.Postoperatively, the patients received enoxaparin and warfarin.· the oversize of the device was 10%.· there was no significant curvature or other notable geometry in the patient's aorta around the landing zone.· there was no extension device used and no plan to use an extension device.· there was no signs of thrombus generation from scans or blood tests.4112 - analysis of information provided by user/third party: scan review was not performed as sme (subject matter expert) confirmed that, the event of acute kidney injury will not be visible on the scan as this has been determined by blood tests.The implantation of a thoraflex hybrid device does not require any surgical access in the abdomen, so can't see how the event can be considered to be device related.Investigation findings: 213 - no device problem found: comprehensive batch review had been performed, no issue were identified during manufacture of this device.Device manufactured to specification.Also investigation conclusion: 22 - known inherent risk of device: ifu (instructions for use) review was performed and thoraflex hybrid us ifu (301-213-usen) rev 2.0 section 6 table 2 states renal complications e.G acute kidney injury 4310 -cause traced to non-device related factors: scan review was not performed as sme (subject matter expert) confirmed that, the event of acute kidney injury will not be visible on the scan as this has been determined by blood tests.The implantation of a thoraflex hybrid device does not require any surgical access in the abdomen, so can't see how the event can be considered to be device related.
Event or Problem Description
Event was reported by clinical study: extend - (b)(4).On post-operative day 1, site reported an adverse event of acute kidney injury' - with further details stating nephrology consulted.The event was considered] unresolved, still treating' at time of report.The patient continued in the study.Concomitant medications taken at the time of the event include aspirin, clonidine, metoprolol tartrate, nifedipine, heparin and protamine.This report is being submitted as follow up #1 for manufacturing report number 9612515-2025-00028 to provide event closure information for (b)(4).
Additional Manufacturer Narrative
Clinical code: 4882 - kidney injury: the site reported an adverse event (ae) of acute kidney injury'.Impact code: 4644 - medication required: the patient was not anticoagulated preoperatively, except for their aspirin that was normally prescribed.Postoperatively, the patients received enoxaparin and warfarin.Medical device code: 2993 - adverse event without identified device or use problem: scan review was not performed as sme (subject matter expert) confirmed that, the event of acute kidney injury will not be visible on the scan as this has been determined by blood tests.The implantation of a thoraflex hybrid device does not require any surgical access in the abdomen, so can't see how the event can be considered to be device related.Component code: 4755 - part/ component/ sub-assembly term not applicable.Type of investigation: 4110 - trend analysis: 4-year review was performed; occurrence rate was (b)(4).No trend identified at this time.3331 - analysis of production records: comprehensive batch review had been performed; no issue were identified during manufacture of this device.Device manufactured to specification.4117 - device not accessible for testing: device remains implanted.4111 - communication/interview: additional information was received on 25 mar 2025 which confirmed: · the patient outcome is currently that the patient is getting repeat kidney function labs next week.· there were no scans or ultrasounds for the kidneys completed.· the patient was not anticoagulated preoperatively, except for their aspirin that was normally prescribed.Postoperatively, the patients received enoxaparin and warfarin.· the oversize of the device was 10%.· there was no significant curvature or other notable geometry in the patient's aorta around the landing zone.· there was no extension device used and no plan to use an extension device.· there was no signs of thrombus generation from scans or blood tests.4112 - analysis of information provided by user/third party: scan review was not performed as sme (subject matter expert) confirmed that, the event of acute kidney injury will not be visible on the scan as this has been determined by blood tests.The implantation of a thoraflex hybrid device does not require any surgical access in the abdomen, so can't see how the event can be considered to be device related.Investigation findings: 213 - no device problem found: comprehensive batch review had been performed; no issue were identified during manufacture of this device.Device manufactured to specification.Also.Investigation conclusion: 22 - known inherent risk of device: ifu (instructions for use) review was performed and thoraflex hybrid us ifu (301-213-usen) rev 2.0 section 6 table 2 states renal complications e.G acute kidney injury.4310 -cause traced to non-device related factors: scan review was not performed as sme (subject matter expert) confirmed that, the event of acute kidney injury will not be visible on the scan as this has been determined by blood tests.The implantation of a thoraflex hybrid device does not require any surgical access in the abdomen, so can't see how the event can be considered to be device related.

• Brand Name: THORAFLEX HYBRID PLEXUS
• Common Device Name: THORAFLEX HYBRID
• Manufacturer (Section D): VASCUTEK LTD; newmains avenue; inchinnan buiness park; renfrewshire, glasgow PA4 9 RR; UK PA4 9RR
• Manufacturer (Section G): VASCUTEK LTD; newmains avenue; inchinnan buiness park; renfrewshire, glasgow PA4 9 RR; UK PA4 9RR
• Manufacturer Contact: laura allan ; newmains avenue; inchinnan buiness park; renfrewshire, glasgow PA4 9-RR ; UK PA4 9RR
• MDR Report Key: 21686748
• Report Number: 9612515-2025-00028
• Device Sequence Number: 21097127
• Product Code: QSK
• UDI-Device Identifier: 05037881026831
• UDI-Public: 05037881026831
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/30/2025

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 Model Number: N/A
• Device Catalogue Number: THP3034X150A
• Device Lot Number: 25693676
• 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: 03/04/2025
• Supplement Date Received by Manufacturer: 03/04/2025; 03/04/2025
• Initial Report FDA Received Date: 03/25/2025
• Supplement Report FDA Received Date: 04/30/2025; 04/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/29/2024
• 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 Age: 43 YR
• Patient Sex: Male