MAUDE Adverse Event Report: WILLIAM COOK EUROPE ZENITH ALPHA¿ THORACIC ENDOVASCULAR GRAFT PROXIMAL COMPONENTS; MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Model Number	G35369
Medical Device Problem Code	Device Tipped Over (2589)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/28/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturer ref# (b)(4).Investigation is still in progress.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
Event or Problem Description
Description of event according to initial reporter: upon deployment of the device, the proximal edge of the graft was tipped sideways.They successfully completed the procedure by removing the delivery system and ballooning the proximal edge of the graft to get it to oppose the aortic wall.Patient outcome: the patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
Manufacturers ref# (b)(4).Summary of investigational findings: upon deployment of a zta-p-44-125-w (complaint device), the proximal edge of the graft was tipped sideways.They successfully completed the procedure by removing the delivery system and ballooning the proximal edge of the graft to get it to oppose the aortic wall.The patient´s anatomy was reported to be tortuous.No adverse events to the patient were reported.Per the reported information, a zta-p-36-113-w and a zta-pt-32-28-201-w were also implanted during the same procedure.The zta-pt-32-28-210-w was modified.A procedure video of zta-p-44-125-w deployment with a side by side and fused 3d overlay is provided along with the complaint report and reviewed by an imaging expert.Per the findings in the imaging review ¿the zta-p was advanced through a t-branch and pre-existing descending thoracic stents.The tortuous path involved two 90-degree bends spanning the elongated thoracic aortic course along the diaphragm.Based on the initial deployment location, the intended target was the mid descending thoracic aorta.As result of the tortuosity, the left lateral delivery sheath at the bare and sealing stents was in contact with the pre-existing endograft.Although off-center, the delivery system was generally parallel with the aortic contour until unsheathed.Upon unsheathing, the delivery system relaxed along the guide wire to the aortic arch inner curvature.This tipped the medial side of the partially constrained sealing stent into the middle of the channel while the lateral portion remained compressed along the lateral aorta.The angle of distal delivery system relative to the aorta changed from generally parallel to 42.9 degrees across the aortic centerline (63.9 degrees-21 degrees).As the trigger wires were retracted, the bare stent and sealings stents flared in a flower like configuration towards the medial aortic wall.Aortic pulsation against the exposed sealing stent, forced the endograft distally until the bare stents perched on the inner aortic curvature.Partially resolution by delivery catheter removal demonstrated that the bare and sealing stents would move relatively easily proximally.As included in the report, subsequent balloon angioplasty was sufficient to produce a seal between the zta-p and the pre-existing graft.Although, the zta-p sealing stent¿s final location would have been lower than where it was unsheathed, the complaint report confirms that the final location was adequate¿.No evidence to suggest that the product was not manufactured according to specifications.Based on the provided information and imaging review, it has not been possible to determine the exact cause of the reported event.However, tortuous anatomy could have contributed to the angled zta-p-44-125-w deployment.It was noted that zta-pt-32-28-210-w was modified.Device modification is not supported by the instructions for use or clinical testing of the device.Cook medical will continue to monitor for similar events.This report is required by the fda under 21cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• Brand Name: ZENITH ALPHA¿ THORACIC ENDOVASCULAR GRAFT PROXIMAL COMPONENTS
• Common Device Name: MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): WILLIAM COOK EUROPE; sandet 6; bjaeverskov 4632 ; DA 4632
• Manufacturer (Section G): WILLIAM COOK EUROPE; sandet 6, dk-4632; bjaeverskov
• Manufacturer Contact: lissi walmann ; sandet 6, dk-4632; bjaeverskov
• MDR Report Key: 15930105
• Report Number: 3002808486-2022-01046
• Device Sequence Number: 11879031
• Product Code: MIH
• UDI-Device Identifier: 10827002353692
• UDI-Public: (01)10827002353692(17)251010(10)E4316081
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P140016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/23/2023

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/10/2025
• Device Model Number: G35369
• Device Catalogue Number: ZTA-P-44-125-W
• Device Lot Number: E4316081
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/28/2022
• Supplement Date Received by Manufacturer: 01/20/2023
• Initial Report FDA Received Date: 12/07/2022
• Supplement Report FDA Received Date: 01/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/10/2022
• 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: Hospitalization
• Patient Sex: Male