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-13-39-ZT

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/23/2014

Event Type  malfunction  

Event Description

A (b)(6) year old male underwent evar on (b)(6) 2014.The surgeon was withdrawing the introducer and the graft also withdrew in full deployed position, then stopped and disconnected from the ipsilateral side of the main body.The surgeon stated that it was hard to remove the zsle and it took a lot of time.The next graft (b)(4) was implanted without any problems.There is no planning or sizing information or images available.There was no vessel damage when the device was removed from the patient.The physician did say the tip of the sheath got caught on the seal stent but the second leg worked well on the same side.The patient's anatomy is not tortuous or calcified.No information was provided regarding patient outcome.

Manufacturer Narrative

No consequence to patient reported.Difficult to remove.Event is 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: 4229919
• MDR Text Key: 5066339
• Report Number: 1820334-2014-00516
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• PMA/PMN Number: P020018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/23/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2017
• Device Catalogue Number: ZSLE-13-39-ZT
• Device Lot Number: 4717682
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/07/2014
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/23/2014
• Device Age: 6 MO
• Event Location: Hospital
• Date Manufacturer Received: 09/24/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/01/2014
• 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