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

Model Number	G47485
Medical Device Problem Codes	Failure to Advance (2524); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/19/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer ref# (b)(4).Pma/510k: p180001.Investigation is still in progress.
Event or Problem Description
Description of event according to initial reporter: device would not pass through the right common iliac artery.A little bit of calcification and tortuosity.A different cook device was used.Patient outcome: the complainant did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
Manufacturer ref# (b)(4).After investigation the event for this pr# is no longer reportable.Summary of investigational findings: a 74-year-old male underwent a surgery, where a zdeg-pt-40-32-165-pf-us (complaint device) was to be implanted.The patient´s anatomy was reported to have a little bit of calcification, tortuosity and narrowing at the internal iliac and common iliac.Physician states that this didn¿t appear on ct.It was reported that the device would not pass through the right common iliac artery.A different cook device was used, and the procedure was completed.The patient did not experience any adverse effects.No device was returned, and no images were received.Review of the device history record gave no indication of the device being produced out of specification.Based on the provided information tortuous anatomy, calcification and narrowing in the internal iliac and common iliac might have contributed to the advancement inability.Cook will reopen the complaint if further information is received.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: 14546072
• Report Number: 3002808486-2022-00752
• Device Sequence Number: 6774090
• Product Code: MIH
• UDI-Device Identifier: 10827002474854
• UDI-Public: (01)10827002474854(17)250309(10)E4230857
• 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: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/21/2022

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 Expiration Date: 03/09/2025
• Device Model Number: G47485
• Device Catalogue Number: ZDEG-PT-40-32-165-PF-US
• Device Lot Number: E4230857
• 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: 05/19/2022
• Supplement Date Received by Manufacturer: 07/20/2022
• Initial Report FDA Received Date: 05/31/2022
• Supplement Report FDA Received Date: 07/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/09/2022
• 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
• Patient Age: 74 YR
• Patient Sex: Male