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-42-81-T-PF

Device Problems Leak/Splash (1354); Torn Material (3024)

Patient Problem No Patient Involvement (2645)

Event Date 11/13/2014

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Similar to device under 510(k): p070016.Summary of investigational findings: visual inspection found captor valve torn which is assumed to be the root cause of this event.Based on what is reported and the results of the investigation unknown how and when the disk was torn, however this tearing of discs most likely happened somewhere during the procedure.Internal actions have been initiated.No evidence to suggest that this device was not manufactured according to specifications.Cook medical will continue to monitor for similar events.

Event Description

Description of event according to initial reporter: to place the extension to treat type i endoleak, the user prepared zenith tx2 taa endovascular graft taa ancillary component distal extension.However he could not flush the delivery system enough due to large amount of leakage from the hemostatic valve.He gave up on using the device and performed ballooning again.The endoleak was resolved by the ballooning and the procedure was completed.Patient outcome: the patient did not experience any adverse effects due to this occurrence.

• 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: 6348605
• MDR Text Key: 67942310
• Report Number: 3002808486-2017-00600
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 10827002526454
• UDI-Public: (01)10827002526454(17)161129(10)E3160346
• 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: 11/13/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ESBE-42-81-T-PF
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/14/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/29/2013
• 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
• Patient Age: 79 YR