MAUDE Adverse Event Report: WILLIAM COOK EUROPE ZENITH® TX2 DISSECTION ENDOVASCULAR GRAFT TAPERED COMPONENT; MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Model Number	G47467
Medical Device Problem Codes	Entrapment of Device (1212); Off-Label Use (1494)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	05/20/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Description of event according to initial reporter: physician modified graft and created 4 fenestrations for the syliac sma left and right renal.They deployed the graft and were able to get out the fenestrations and were able to place stents out the fenestrations.But they had a small dissection in the silliac which they were able to stent and fix.Then another dissection in the sma (superior mesenteric artery) which they were not able to fix right away and had to go in and do a bypass on.Patient outcome: the event did require an additional procedure due to this occurrence: bypass the patient did not report any adverse effects due to this occurrence.The patient was hospitalized or was there prolonged hospitalization due this occurrence: there probably will be a longer than expected hospital stay.
Additional Manufacturer Narrative
Manufacturer ref# (b)(4).Pma: p180001.Investigation is still in progress.
Event or Problem Description
Additional information received 01jun2022: fenestrations were created before the case.They were created on the table and then resheathed.No issues with it.They were not done in the pt.
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.
Additional Manufacturer Narrative
Manufacturer ref# (b)(4).Summary of investigational findings: a 72-year-old female patient with a thoracoabdominal aneurysm was treated with a zdeg-pt-32-202-pf-us (complaint device), which was modified prior to implantation and the stent graft was resheated.4 fenestrations for the celiac artery, sma (superior mesenteric artery), left and right renal artery have been done.The physicians deployed the stent graft, were able to get out the fenestrations to place stents out the fenestrations.A small dissection in the celiac artery has occurred but the physicians were able to stent and fix it.Then another dissection in the sma occurred.This time the physicians were not able to fix it right away.A bypass has been performed.A longer hospital stay has been expected.No imaging was provided for investigation.Review of the device history record gave no indication of the device being produced out of specification.According to the ifu, zdeg is indicated for the endovascular treatment of patients with type b aortic dissection.Consequently, use of zdeg device for treatment of a thoracoabdominal aneurysm is outside of intended use.Additionally, device modification is not supported by the instructions for use or clinical testing of the device.Based on the provided information it has not been possible to establish a conclusive cause of the reported event as the stent graft was modified before use.Cook medical will continue to monitor for similar events.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
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• Brand Name: ZENITH® TX2 DISSECTION ENDOVASCULAR GRAFT TAPERED COMPONENT
• 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: 14563966
• Report Number: 3002808486-2022-00753
• Device Sequence Number: 4943584
• Product Code: MIH
• UDI-Device Identifier: 10827002474670
• UDI-Public: (01)10827002474670(17)250328(10)E4239187
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/08/2022

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
• Device Expiration Date: 03/28/2025
• Device Model Number: G47467
• Device Catalogue Number: ZDEG-PT-32-202-PF-US
• Device Lot Number: E4239187
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/20/2022
• Supplement Date Received by Manufacturer: 06/01/2022; 10/07/2022
• Initial Report FDA Received Date: 06/01/2022
• Supplement Report FDA Received Date: 06/28/2022; 10/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/28/2022
• 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: 72 YR
• Patient Sex: Female