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

Catalog Number ZTA-P-30-155-W1

Device Problems Improper or Incorrect Procedure or Method (2017); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Paralysis (1997)

Event Date 01/23/2024

Event Type  Injury  

Manufacturer Narrative

Manufacturer ref# (b)(4) blank fields on this form indicate the information is unknown or unavailable.G4) similar to device under pma/510(k) p140016 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: patient anatomy before surgery and at the time of failure:although not numerous, some degree of mural thrombus was observed in the descending aorta.Devices used: zta-p-30-155-w1 (lot# e4247197) - approached from the right femoral artery to the descending aorta zta-pt-40-36-217-w1 (lot# e4182403) - approached from the right femoral artery to the aortic arch this was a case of 2-debranching tevar.The procedure was completed without any problems using standard tevar procedures.Immediately after the surgery, the movement of both lower limbs was poor, however, at this point, it was unclear whether the poor movement of both lower limbs was due to spinal cord ischemia due to the scattering of mural thrombi, whether it was simply because it took time to wake up from anesthesia, or whether it was due to his pre-existing condition, cerebral infarction.And the patient did not recover even after 1 week after the surgery.An mri scan revealed scattered embolization around th6 and 7 (thoracic spines 6 and 7).Patient outcome.The patient was left with paralysis in both lower limbs as an sequela.Future plans for additional treatment are unknown.

Event Description

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

Manufacturer Narrative

Manufacturers ref# (b)(4).After investigation the event for this (b)(4) is no longer reportable.Summary of investigational findings: an 81-year-old male patient underwent 2-debranching tevar (thoracic endovascular aortic repair), where zta-p-30-155-w1 was approaching to the descending aorta and zta-pt-40-36-217-w1 to the aortic arch.Patient anatomy before surgery and at the time of failure was reported with some degree of mural thrombus in the descending aorta.The procedure was completed without any problems.Immediately after the surgery, the movement of both lower limbs was poor, however, at this point, it was unclear whether the poor movement of both lower limbs was due to spinal cord ischemia due to the scattering of mural thrombus, whether it was simply because it took time to wake up from anesthesia, or whether it was due to his pre-existing condition, cerebral infarction.And the patient did not recover even after 1 week after the surgery.An mri scanning (magnetic resonance imaging) revealed scattered embolization around th6 and th7 (thoracic spines 6 and 7).The patient was left with paralysis in both lower limbs as an sequela.Future plans for additional treatment are unknown.No imaging was provided for the investigation.Paralysis is listed as a potential adverse effect in the instructions for use (ifu).Based on the reported information an exact cause cannot be established.However, as nothing indicates that the event is related to fault conditions of the device or abnormal use of the device, the event is assessed to be a side effect, which potentially could be related to procedure and patient medical condition.It is noted that zta is used in 2-debranching tevar.According to the ifu, the zenith alpha thoracic endovascular graft is designed to treat proximal aortic necks (distal to either the left subclavian or left common carotid artery) of at least 20 mm in length.Additional proximal aortic neck length may be gained by covering the left subclavian artery (with or without discretionary transposition) when necessary to optimize device fixation and maximize aortic neck length.Cook medical will continue to monitor for similar events.This report is required by the fda under 21cfr 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
• 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; bjaeverskov 4632 ; DA 4632
• Manufacturer Contact: alex rahbek ; sandet 6; bjaeverskov 4632 ; DA 4632 ; 56868686
• MDR Report Key: 18738339
• MDR Text Key: 335743303
• Report Number: 3002808486-2024-00033
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 10827002449463
• UDI-Public: (01)10827002449463(17)250413(10)E4247197
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/20/2024

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-P-30-155-W1
• Device Lot Number: E4247197
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/08/2024
• Initial Date FDA Received: 02/20/2024
• Supplement Dates Manufacturer Received: 03/14/2024
• Supplement Dates FDA Received: 03/20/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/13/2022
• 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): Life Threatening
• Patient Age: 81 YR
• Patient Sex: Male