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-30-108-W1

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

Manufacturer ref# (b)(4).Catalog #: is unknown but referred to as cook zenith device.(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.

Event Description

Description of event according to initial reporter: two years ago: a 76-year-old male patient received total arch replacement with elephant trunk to treat thoracic descending aorta aneurysm with shaggy aorta arch.It was done to achieve proximal landing.Two months after: tevar was performed using zenith devices(2 of 30mm-200mm and a 30mm-100mm).Later: open surgery was performed because of growth of the taa and the migration of the distal stent graft.Therefore, vessel replacement with leaving only a stent graft that was placed in the proximal side was performed.About spinal perfusion, an extrathoracic network from the left subscapular artery to the intercostal artery (adamkiewicz artery) was found in the broad back muscle.Therefore, the chest was opened by excision of the costal arch on the anterior side and the left sixth intercostal space to preserve the broad back muscle.No paraplegia was confirmed after the surgery.

Event Description

Additional information provided on 06jul2022: - the patient's anatomical form was suitable for endovascular repair although the access vessel was thin.No damaging vessels were occurred during the procedure.- all devices implanted for this case were as below.Zta-de-30-108-w1(e3696439) was placed first in the most distal side, and then 2 of zta-p-30-201-w1 were placed in the proximal side.The lot numbers of them were e3706590 and e3716636 but it's unknown which is most proximal or 2nd proximal.Zta-p-30-201-w1; e3706590; zta-p-30-201-w1 ;e3716636 ;zta-de-30-108-w1; e3696439.Additional information received 13jul2022: the suspected cause(s) for the aneurysm growth and graft migration is type iiib endoleak.It was logged as (b)(4).(manufacturer report # 3002808486-2021-01044).

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.

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).This complaint will be closed/cancelled as the event is already handled in the linked complaint (b)(4) (manufacturer report # 3002808486-2021-01044).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
• MDR Report Key: 14785670
• MDR Text Key: 294569550
• Report Number: 3002808486-2022-00856
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 10827002449142
• UDI-Public: (01)10827002449142(17)210305(10)E3696439
• 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: 07/27/2022

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 Catalogue Number: ZTA-DE-30-108-W1
• Device Lot Number: E3696439
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/27/2022
• Initial Date FDA Received: 06/23/2022
• Supplement Dates Manufacturer Received: 07/06/2022; 09/19/2022
• Supplement Dates FDA Received: 07/27/2022; 09/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/05/2018
• 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: 76 YR
• Patient Sex: Male