MAUDE Adverse Event Report: WILLIAM COOK EUROPE ZENITH TX2 TAA ENDOVASCULAR GRAFT TAA ANCILLARY COMPONET DISTAL EXTENSION; MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Catalog Number ESBE-38-77-T-PF

Device Problem Device Damaged Prior to Use (2284)

Patient Problem No Patient Involvement (2645)

Event Date 03/14/2014

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Similar to device under 510(k) p070016.Summary of investigational findings: based on the information provided, it was not possible to conclude an exact root cause for this event.It is however considered highly unlikely that this product was manufactured with a bended stylet.It is extremely difficult to advance a bended stylet through the needle wire.It is most likely that the damage to the product happened during shipping or at the hospital.Cook medical will continue to monitor for similar events.

Event Description

Description of event according to initial reporter: at a preparation, the user attempted to remove the stylet from the delivery system but the stylet would not be removed.There was no back-up, so the procedure was finished without using this product.Patient outcome: prior to patient contact.

• Brand Name: ZENITH TX2 TAA ENDOVASCULAR GRAFT TAA ANCILLARY COMPONET DISTAL EXTENSION
• Type of Device: MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): WILLIAM COOK EUROPE; 4632 bjaeverskov; DA
• Manufacturer Contact: marianne hoey ; sandet 6; bjaeverskov 4632 ; DA 4632 ; 56868686
• MDR Report Key: 6313396
• MDR Text Key: 66873021
• Report Number: 3002808486-2017-00372
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 10827002526430
• UDI-Public: (01)10827002526430(17)160422(10)E3076613
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ESBE-38-77-T-PF
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/14/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/22/2013
• 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