MAUDE Adverse Event Report: COOK INC. ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT LLIAC LEG; MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Catalog Number ZSLE-16-74-ZT

Device Problem Other (for use when an appropriate device code cannot be identified) (2203)

Patient Problem Pain (1994)

Event Date 03/28/2014

Event Type  Injury  

Event Description

A male patient with infrarenal aneurysm with bilateral common iliac aneurysm underwent evar with zenith low profile and ibd on (b)(6) 2014.As the low profile main body was being prepared on sterile field the surgeon was attempting to remove the shipping inner stylet (this a protective wire in the 035 chamber) which was not moving at all with various amounts of force.Upon visual inspection there was no kink or bend in the device.The rep then asked for them to take a hemostat in attempt to pull back but surgeon pull hard and removed the black hub on stylet making the device unusable.Upon removal of the coda device through contra lateral zenith zsle sheath it was noticed from the surgeon that long filamentous strands were being removed from sheath as coda was coming out of sheath.The main worry was that potential strand(s) would travel downward into the leg and cause emboli of an artery in the leg.It is believed that all strands were removed but patient has been monitored very closely over the weekend, and is kept an extra few days just in case.Patient has complained of slight pain in right leg and certain discoloration has been observed and additional hospital stay.No additional information has been provided.

Manufacturer Narrative

(b)(4).Event evaluation: still under investigation.

• Brand Name: ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT LLIAC LEG
• Type of Device: MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): COOK INC.; bloomington IN 47404
• Manufacturer Contact: rita harden, director ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 3779393
• MDR Text Key: 4435246
• Report Number: 1820334-2014-00181
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P020018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/28/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2016
• Device Catalogue Number: ZSLE-16-74-ZT
• Device Lot Number: 4006872
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/08/2014
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/28/2014
• Device Age: 14 MO
• Event Location: Hospital
• Date Manufacturer Received: 04/01/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/23/2013
• 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 Outcome(s): Other