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-28-201

Device Problem Device Dislodged or Dislocated (2923)

Event Date 01/02/2024

Event Type  Injury  

Manufacturer Narrative

Manufacturers ref# (b)(4).G4) similar to device marketed under pma/510(k): p140016.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 study: from follow-up ct/mri, endoleaks: type iii = yes.Is there evidence of device issue(s)? = no.35 days post procedure imaging show: endoleak type iii = yes.Is there evidence of device issue(s)? = no.Patient outcome: was a new secondary intervention performed to treat the endoleak(s)? = no.

Manufacturer Narrative

Manufacturer ref# (b)(4).Additional information received 27mar2024 states, that imaging reviewer has noticed that it is a type ii endoleak deriving from the intercostal artery.Since type ii endoleak is not related to the device, but due to patient anatomy, event is now considered not reportable to fda.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

Additional information received 27mar2024: this is to inform you that the doctors have evaluated the ct scan images and have noticed that it is a type ii endoleak deriving from the intercostal artery.As a type ii endoleak, this is not a device-borne issue.In this specific case, an intercostal artery about halfway up the graft supplies waste blood to the aneurysm.Type ii endoleaks are also very common in the abdominal aorta.It is not a defect of either the device or the system.

• 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: 18719289
• MDR Text Key: 335523476
• Report Number: 3002808486-2024-00026
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 10827002346847
• UDI-Public: (01)10827002346847(17)260706(10)E4424718
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Study
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/03/2024

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-28-201
• Device Lot Number: E4424718
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/05/2024
• Initial Date FDA Received: 02/16/2024
• Supplement Dates Manufacturer Received: 03/27/2024
• Supplement Dates FDA Received: 04/03/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/06/2023
• 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): Other
• Patient Age: 43 YR
• Patient Sex: Male
• Patient Weight: 80 KG