MAUDE Adverse Event Report: WILLIAM COOK EUROPE ZENITH® DISSECTION ENDOVASCULAR STENT; MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Catalog Number ZDES-36-80-US

Device Problem Difficult to Advance (2920)

Patient Problem Insufficient Information (4580)

Event Date 01/17/2024

Event Type  malfunction  

Manufacturer Narrative

Manufacturers ref# (b)(4).G4) pma/510(k): p180001 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: zdes-36-80-us lot e4358915 did not have a smooth tip to sheath transition and therefore could not be advanced into a sheath.Device was not deployed.Patient outcome: the complainant did not report any adverse effects to the patient due to this occurrence.

Manufacturer Narrative

Manufacturers ref# (b)(4).B5 has been updated with additional information.Investigation is still in progress.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

Additional information received 01mar2024: the device could not be advanced past the valve.The device could not be advanced into a sheath that was already in the body.A prior device was able to be advanced through the sheath and also a subsequent device.The device in question kept catching and could not be advanced.

• Brand Name: ZENITH® DISSECTION ENDOVASCULAR STENT
• 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: 18578103
• MDR Text Key: 333700035
• Report Number: 3002808486-2024-00012
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 10827002474915
• UDI-Public: (01)10827002474915(17)260118(10)E4358915
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ZDES-36-80-US
• Device Lot Number: E4358915
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/17/2024
• Initial Date FDA Received: 01/25/2024
• Supplement Dates Manufacturer Received: 03/01/2024
• Supplement Dates FDA Received: 03/26/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/18/2023
• 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 Age: 50 YR
• Patient Sex: Female