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

Catalog Number ZTA-DE-26-104-W1

Device Problems Entrapment of Device (1212); Off-Label Use (1494); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Ulcer (2274); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 09/17/2021

Event Type  Injury  

Manufacturer Narrative

Manufacturer ref# pr(b)(4).Similar to device marketed under pma/510(k): p140016.Investigation is still in progress.

Event Description

Description of event according to the initial reporter: (b)(6) 2020: a (b)(6) year old male patient with dissecting aneurysm of aorta underwent tevar.No problem in the access vessels.The distal aorta arch was slightly tortuous.Zta-pt-34-30-161-w1(e3859589) was placed in the proximal side and zta-de-26-104-w1(e3911902) was placed in the distal side successfully.(b)(6) 2021: endoleak was observed by ct at the distal end of the previously placed zta-de-26-104-w1(e3911902).Additional procedure to treat this was planned.(pr(b)(4)).(b)(6) 2021: additional procedure and angiography was performed.But the endoleak was not shown in the angiography imaging, but ulp(ulcer like projection) was shown where endoleak had been observed.The physician determined to treat this ulp by placing zta-p-28-155-w1.After ulp was covered by stent graft, it resolved largely.(included in pr(b)(4)).Then he decided to place zta-p-34-209-w1 from right below the left subclavian artery as a lining because there was diameter size differences between the previously placed zta-de-26-104-w1 and zta-p-28-155-w1, and also for preventive purpose of endoleak from the junction of zta-pt-34-30-161-w1 and zta-de-26-104-w1.He started to advance the delivery system of zta-p-34-209-w1, but near the distal aorta arch, he felt resistance at its tip.However he kept trying to advance the delivery system and it resulted in detachment of the sheath from the hemostatic valve assembly.(pr344777) so, he replaced it with zta-p-34-161-w1 but felt resistance when it was advanced in the middle of placed zta-p-28-155-w1.He thought it was due to a kink in the wire guide tscmg-35-300-e-lesdc and replaced it with another one with the different lot.(pr344778) then he could advance the delivery system with no problem and placed the stent graft right below the left subclavian artery.The procedure was completed without paraplegia or any other problems.Patient outcome: according to the initial reporter, the patient did not experience any adverse effects due to this occurrence.The patient did require an additional procedure due to this occurrence.

Event Description

No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

Manufacturer Narrative

Manufacturer ref# (b)(4).After re-investigation, update and correction to annex d and annex a.No change to summary of investigational findings submitted in mdr follow up 1 on 28apr2022.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 Description

No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

Manufacturer Narrative

Manufacturer ref# (b)(4).Summary of investigational findings: a 77- year-old male patient with dissecting aneurysm of aorta underwent a tevar (thoracic endovascular aortic repair) on the (b)(6) 2020, where a zta-pt-34-30-161-w1 was placed proximally and a zta-de-26-104-w1 (complaint device) was placed distally.Diameter of the proximal and distal fixation sites was reported to be 30-31mm and 24-25mm accordingly.The patient´s anatomy was reported to be slightly tortuous in the distal aorta arch.The iliac artery had calcification.No calcification was reported in the thoracic aorta.Ct dated (b)(6) 2021 revealed a type 1 endoleak at the distal end of the zta-de-26-104-w1.On the (b)(6) 2021 the additional procedure was performed.The angiography during the procedure endoleak did not show the endoleak but showed an ulp (ulcer like projection).So the physician determined the endoleak-like-imaging observed in earlier ct was actually the ulp.The physician determined to treat this ulp by placing a zta-p-28-155-w1.After ulp was covered by stent graft, it resolved largely.Then the physician decided to place a zta-p-34-209-w1 device from right below the left subclavian artery as a lining because there were diameter size differences between the zta-de-26-104-w1 and the zta-p-28-155-w1, and also for preventive purpose of endoleak from the junction of the zta-pt-34-30-161-w1 and the zta-de-26-104-w1.During the advancement of the zta-p-34-209-w1, he felt resistance near the distal aorta arch.However, he kept trying to advance the delivery system and it resulted in detachment of the sheath from the hemostatic valve assembly ((b)(4)).The physician replaced the zta-p-34-209-w1 with a zta-p-34-161-w1 but felt resistance during advanced in the middle of the zta-p-28-155-w1.He thought it was due to a kink in the wire guide tscmg-35-300-e-lesdc and replaced it with another one ((b)(4)).Then he could advance the delivery system with no problem and placed the stent graft right below the left subclavian artery.The procedure was successfully completed.The patient did not experience any adverse effects.The device was not returned, and no images was provided.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.Per ifu the safety and effectiveness of the zenith alpha thoracic endovascular graft and ancillary components have not been evaluated in the dissections.Also, per ifu in the potential adverse event section, aortic damage may occur.Based on the provided information it has not been possible to determine the cause of the ulcer.It is noted that zta is used for treatment of dissection, which is outside of intended use.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.

• Brand Name: ZENITH ALPHA¿ THORACIC ENDOVASCULAR GRAFT DISTAL EXTENSIONS
• Type of Device: 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: 12638119
• MDR Text Key: 276846923
• Report Number: 3002808486-2021-01878
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 10827002449104
• UDI-Public: (01)10827002449104(17)221022(10)E3911902
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 06/28/2022

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 Operator: Health Professional
• Device Expiration Date: 10/22/2022
• Device Catalogue Number: ZTA-DE-26-104-W1
• Device Lot Number: E3911902
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/14/2021
• Initial Date FDA Received: 10/15/2021
• Supplement Dates Manufacturer Received: 04/26/2022; 06/22/2022
• Supplement Dates FDA Received: 04/27/2022; 06/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/22/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 77 YR
• Patient Sex: Male