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

Model Number	G35355
Medical Device Problem Codes	Off-Label Use (1494); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	07/25/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturer ref# (b)(4).Pma/510(k): p140016.Investigation is still in progress.
Event or Problem Description
Description of event according to the initial reporter: component separation.Overlap section not included in scan range.Component separation, on (b)(6) 2018: thoracic endograft gore 40x150.Component separation repair.Patient outcome: according to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
Event or Problem Description
Implant procedure: on (b)(6) 2017 with zta a fen-thoraco-abdominal-graft (cmd).Component separation: (b)(6) 2018.
Additional Manufacturer Narrative
Manufacturer ref# (b)(4).Summary of investigational findings: cook was notified of this event through an excel spreadsheet supplied by cleveland clinic.A patient underwent a evar (endovascular repair) on (b)(6) 2017, where a zta-p-36-161-w (complaint device) and a fen-thoraco-abdominal-graft (cmd).On (b)(6) 2018 component separation between zta and cmd has occurred.The patient underwent a secondary intervention on (b)(6) 2018, where a gore graft was used to re-line the separation gap.This complaint is related to wca complaint pr344410 (component separation).Ctas and angiography from (b)(6) 2016 and to (b)(6) 2019 including pre-procedure, post-procedure and follow-up imaging were provided reviewed: on the pre-operative ct dated (b)(6) 2016 max.Thoracic aorta aneurysm diameter measured 61,4 mm; max.Abdominal aorta aneurysm diameter measured 38,8 mm.Maximum localized aortic angulation of the distal thoracic aorta was measured to 100 degrees.On the follow-up ct dated (b)(6) 2017 maximum localized aortic angulation (in area of zta) was measured to 102 degrees, overlap was measured 44,0mm and max.Thoracic aorta aneurysm was 64,0mm.On the follow-up ct dated (b)(6) 2018 complete loss of overlap was observed.Max.Thoracic aorta aneurysm diameter measured 67,8 mm; max.Abdominal aorta aneurysm diameter measured 53,8 mm.Input from cook global planning services provided that the evar components were planned by the customer physician.According to the fen-thoraco-abdominal-graft (cmd) drawing (refer to attached files) the proximal end of the cmd is about 62 mm before the first fenestration, this does not allow a 3 stents overlap between the zta and cmd.The ifu states that the minimum required amount of overlap between devices is 3 stents (~75 mm).Per the clinical assessment ¿note in particular that the cmd, the new alpha graft, and the pre-existing thoracic endograft, all have the same diameter of 36mm, and all are fully expanded.But both overlaps ¿ the insitu graft to new alpha graft, and alpha graft to new cmd ¿ are all slip fits, not interference fits.Also from the above screensnip, it can be seen that the new alpha graft may have been deployed first, with the cmd then being deployed second inside the alpha graft.Also note that the entire overlap region between the in situ graft and the new alpha graft extends around that angulation/curvature of approx.80 degrees¿.Also per clinical assessment ¿the normal movement that occurs in a living person, which is not adequately portrayed in still images, seem to lead to separation of the devices when there is no interference fit between them.These movements include respiratory movements of the diaphragm, pulsation in both longitudinal and transverse directions of the aorta, exaggerated movements during coughing, etc.Add to this the lateral movement of the endograft inside a large aneurysm, if close to the overlap zone, plus change in length or shape of the aneurysm and tortuosity of the aorta that changes over time¿.Review of the device history record found that all discovered non-conformances were properly dispositioned before release and no indication that the device was produced outside of specification.Based on the provided information and clinical assessment it has not been possible to determine a single cause of the reported event.The design of the cmd with only 2 stents above the coeliac fenestration, short initial overlap, angulation and large aneurysm may have contributed to the separation.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.

• 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 ; 56868686
• MDR Report Key: 12645647
• Report Number: 3002808486-2021-01884
• Device Sequence Number: 13796977
• Product Code: MIH
• UDI-Device Identifier: 10827002353555
• UDI-Public: (01)10827002353555(17)200307(10)E3559691
• 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: 2017
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/21/2022

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 Expiration Date: 03/07/2020
• Device Model Number: G35355
• Device Catalogue Number: ZTA-P-36-161-W
• Device Lot Number: E3559691
• 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: 09/22/2021
• Supplement Date Received by Manufacturer: 02/17/2022
• Initial Report FDA Received Date: 10/18/2021
• Supplement Report FDA Received Date: 02/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/07/2017
• 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 Sex: Unknown