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-28-80-T-PF

Device Problem Leak/Splash (1354)

Patient Problem No Patient Involvement (2645)

Event Date 06/03/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Name and address for importer site: (b)(4).Similar to device under 510(k): p070016.Investigation is still in progress.

Event Description

Description of event according to initial reporter: the device was to be used as an emergency treatment.When the physician performed flushing of the complaint device prior to patient contact, leakage of fluid from the hemostatic valve was observed.Therefore, esbe-26-80-t-pf was used instead.Patient outcome: no information provided.

Manufacturer Narrative

Exemption number e2016032.William cook europe aps (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi) (importer).Manufacturers ref# (b)(4).The event is no longer considered reportable in us based on the completed investigation.The event did not, and could not, lead to serious injury to the patient, would the malfunction recur.G1) name and address for importer site: cook medical incorporated (cmi).400 daniels way.Bloomington, in 47404.Registration no.: 3005580113.Summary of investigational findings: as per the reported information, leak from the hemostatic valve was observed when flushing during preparation.The device was replaced with another device prior to use.No adverse effects to the patient have been reported.Since no product was returned, it would be inappropriate to speculate at what may or may not have occurred based on the limited information made available to us, but the flexor sheat has an air pressure inspection on all devices.Cook medical will continue to monitor for similar events.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

No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• 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; sandet 6; bjaeverskov 4632 ; DA 4632
• MDR Report Key: 7624168
• MDR Text Key: 111846188
• Report Number: 3002808486-2018-00716
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 10827002526386
• UDI-Public: (01)10827002526386(17)201204(10)E3660430
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 11/30/2018

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 Expiration Date: 12/04/2020
• Device Catalogue Number: ESBE-28-80-T-PF
• Device Lot Number: E3660430
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 06/04/2018
• Device Age: 6 MO
• Initial Date Manufacturer Received: 06/03/2018
• Initial Date FDA Received: 06/21/2018
• Supplement Dates Manufacturer Received: 11/07/2018
• Supplement Dates FDA Received: 11/30/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 92 YR