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

Catalog Number ZTA-PT-34-30-161-W1

Device Problems Appropriate Term/Code Not Available (3191); Patient Device Interaction Problem (4001)

Event Type  Injury  

Manufacturer Narrative

Manufacturers ref# (b)(4).Blank fields on this form indicate the information is unknown or unavailable.G4) similar to device marketed under pma/510(k): p140016.H6) a050408 - endoleaks.Investigation is still in progress.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.

Event Description

Description of event according to initial reporter: other manufacturer reported a death case to pmda.According to the report a zenith thoracic alpha was placed for thoracic aortic aneurysm (b)(6) 2021.After placement, an enlarged aneurysm was observed due to endoleak (this complaint).Cook japan was informed by pmda of the event on 11jan2024.No special treatments were taken against zenith after the issue occurred.(b)(6) 2023: the patient underwent open stent grafting using terumo/thora flex hybrid (4-branch tube, artificial vessel main tube inner diameter 30mm, stent graft outer diameter 34mm, stent graft length 150mm) to treat the enlarged mass.After placement of thora flex, regurgitation bleeding occurred from the peripheral part of the stent graft.Bleeding was also observed from a part of the collar anastomosis.During hemostasis, bleeding to the cardiopulmonary side was observed.Although no major bleeding was observed in the surgical field, bleeding into the intubation tube (hematemesis) was confirmed.After investigating the cause, it was found that the regurgitation bleeding at the peripheral end of the thora flex stent graft was a type 1b endoleak.Tag (aortic stent graft, central diameter 31 mm, distal diameter 31 mm, graft cover length 150 mm) was placed, and the endoleak disappeared.The patient was returned to the icu on postoperative ecmo, but showed marked decline in pulmonary function.The patient could not be weaned from ecmo, developed emphysema, and died.According to the physician the stent was pulled while anastomosing because the kyphotic side was deeper than expected at the time of collar anastomosis, causing the stent on the side to be pulled, and the kyphotic side was not sealed with the zenith alpha, resulting in type 1b endoleak.Regarding the hematemesis, it is thought that pressure was applied to the leak point during retrograde blood pumping, the aneurysm ruptured, and communication with the bronchus occurred, causing blood to flow into the bronchus.Patient outcome: the patient died.According to the physician the death due to emphysema was a complication of the procedure, not a product-related event.

Manufacturer Narrative

Manufacturers ref# (b)(4).B5) description of event has been corrected investigation is still in progress.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.

Event Description

Corrected description of event: other manufacturer reported a death case to pmda.According to the report a zenith thoracic alpha was placed for thoracic aortic aneurysm (b)(6) 2021.After placement, an enlarged aneurysm was observed due to endoleak type 1a.Cook japan was informed by pmda of the event on 11jan2024.No special treatments were taken against zenith after the issue occurred.

Manufacturer Narrative

Manufacturers ref# (b)(4).Summary of investigational findings: manufacturer terumo reported a death case to pmda and the report said zenith thoracic alpha was used during procedure.This was not the case.Previously, on (b)(6) 2021, the patient underwent tevar and had a zta-pt-34-30-161-w1 (complaint device) implanted to treat a thoracic aortic aneurysm.On (b)(6) 2023, the patient underwent open stent grafting using terumo/thora flex hybrid to treat a different disease in the aortic arch.During this procedure a type 1a endoleak was suspected on the zta device as the aneurysm treated by zta was observed to be enlarged.As the procedure was not related to the zta the physician did not verify the suspected endoleak of zta.No special treatments were taken against the suspected type 1a endoleak for zta.After placement of the terumo/thora flex hybrid regurgitation bleeding occurred from the peripheral part of the stent graft.Bleeding was also observed from a part of the collar anastomosis and to the cardiopulmonary side.Bleeding into the intubation tube (hematemesis) was confirmed.The regurgitation bleeding was found to be due to a type 1b endoleak and an additional stent graft (likely a gore tag) was placed, stopping the endoleak.The patient was returned to the icu on postoperative ecmo, but showed marked decline in pulmonary function.The patient could not be weaned from ecmo, developed emphysema, and died.Review of the device history record gave no indication of the device being produced out of specification.Based on review of available information it has not been possible to determine a cause for the suspected type 1a endoleak for zta-pt-34-30-161-w1 (complaint device).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.

Event Description

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

• Brand Name: ZENITH ALPHA¿ THORACIC ENDOVASCULAR GRAFT PROXIMAL TAPERED 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: 18534038
• MDR Text Key: 333115848
• Report Number: 3002808486-2024-00010
• Device Sequence Number: 1
• Product Code: MIH
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/15/2024

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 Expiration Date: 04/07/2024
• Device Catalogue Number: ZTA-PT-34-30-161-W1
• Device Lot Number: E4092702
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/11/2024
• Initial Date FDA Received: 01/18/2024
• Supplement Dates Manufacturer Received: 01/19/2024; 02/02/2024
• Supplement Dates FDA Received: 01/24/2024; 02/15/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/07/2021
• 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: 78 YR
• Patient Sex: Male