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-38-117

Device Problem Malposition of Device (2616)

Event Date 08/11/2020

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 study: from follow-up ct/mri, endoleaks: endoleak type ib (distal) no evidence of device issue.From follow-up ct/mri, endoleaks: new secondary intervention was performed to treat the endoleak.The only additional procedure performed during the study procedure was placement of a t-branch graft for aaa.

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

Additional information received on 01may2024: the secondary intervention (si) form indicates the intervention was specifically related to the adverse event of type 1b-distal endoleak.However, the adverse events form shows that coil embolization was performed to the intercostal arteries, which may be treatment for the type ii endoleak, although that is not specified.The si form indicates the new graft placed was a distal extension graft; the adverse events form indicates it was an iliac graft.No rpn or manufacturer is noted.

• 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: 19123551
• MDR Text Key: 340340189
• Report Number: 3002808486-2024-00065
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 10827002347028
• UDI-Public: (01)10827002347028(17)211120(10)E3797990
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 05/03/2024

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 Expiration Date: 11/20/2021
• Device Catalogue Number: ZTA-P-38-117
• Device Lot Number: E3797990
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/08/2024
• Initial Date FDA Received: 04/17/2024
• Supplement Dates Manufacturer Received: 05/01/2024
• Supplement Dates FDA Received: 05/03/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/20/2018
• 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 Sex: Male
• Patient Weight: 77 KG