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

Model Number	G53449
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturer ref# (b)(4).Catalog# is unknown but referred to as unknown zteg.(b)(4).Investigation is still in progress.
Event or Problem Description
Description of event according to initial reporter: component separation between zteg 2pt 38 to 34 (the second spreadsheet says ¿zteg 2pt 38-202¿ and main body (34 proximal).A.(¿component separation¿ listed as device related in the final fda report).Patient outcome: according to the initial reporter, the patient did not experience any adverse effects due to this occurrence.The patient did not require any additional procedures due to this occurrence.
Additional Manufacturer Narrative
Manufacturer ref# (b)(4).Blank fields on this form indicate the information is unknown or unavailable.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
Additional information received (b)(6) 2022: rpn og lot#.
Additional Manufacturer Narrative
Manufacturer ref# (b)(4).Summary of investigational findings: a 71-year-old female with a very tortuous taaa with sma occlusion underwent left ilio-sma bypass on (b)(6) 2012, taa placement to exclude the proximal portion of the aneurysm on (b)(6) 2012, followed by a custom 3-vessel branched stent-graft placement to exclude the reminder of the aneurysm on (b)(6) 2013.All vessels were patent and there was no endoleak at the conclusion of the case.Follow-up visits had been unremarkable until (b)(6) 2014, the ct scan revealed a component separation between the branched device and the bifurcated device.This was successfully repaired on (b)(6) 2014.Patient was withdrawn from the study on (b)(6) 2017.Review of device history record gave no indication of the device being produced outside of specifications.Ct and angio is provided, and an imaging review are performed.Per the findings of the imaging reviewer ¿the zteg-2pt-38-202-pf-us successfully excluded the tortuous thoracic aortic aneurysm on all the follow up imaging¿ and ¿the fen pararenal branched graft was initially inserted two stents into the zteg-2pt-38-202-pf-us.The overlap decreased to one stent when the bifurcated graft and fen pararenal branched graft separation was discovered 22aug2014.There was no endoleak or thoracic aneurysm growth¿.Based on these findings the imaging reviewer impression is ¿the complaint of zteg-2pt-38-202-pf-us and fen pararenal branched graft separation is not confirmed¿.Based on the findings in the imaging review no separation or endoleak in relation to the complaint device were found.After investigation the event for this pr350400 is no longer reportable 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 TAA ENDOVASCULAR GRAFT PROXIMAL 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: 13256972
• Report Number: 3002808486-2022-00021
• Device Sequence Number: 4726898
• Product Code: MIH
• UDI-Device Identifier: 10827002534497
• UDI-Public: (01)10827002534497(17)141201(10)E2840931
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/04/2022

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
• Operator of Device: Health Professional
• Device Model Number: G53449
• Device Catalogue Number: ZTEG-2PT-38-202-PF-US
• Device Lot Number: E2840931
• 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: 12/20/2021
• Supplement Date Received by Manufacturer: 01/19/2022; 06/30/2022
• Initial Report FDA Received Date: 01/14/2022
• Supplement Report FDA Received Date: 01/27/2022; 07/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Life Threatening; Required Intervention
• Patient Sex: Unknown