MAUDE Adverse Event Report: COOK, INC. ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY; MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Model Number N/A

Device Problems Repair (1529); Implant, removal of (2320); Appropriate Term/Code Not Available (3191)

Patient Problems Unspecified Infection (1930); Surgical procedure, additional (2564); No Code Available (3191)

Event Date 05/26/2015

Event Type  Injury  

Event Description

A (b)(6) male patient undergoes surgery for removal of the main body graft due to disease progression.The aneurysm was still growing and the graft was possibly infected.The graft was only partially removed.The suprarenal bare metal stent was left in place.The explant was a re-intervention.The patient had open repair and his aorta was reconstructed with a sown in graft.The patient is recovering after the procedure.

Manufacturer Narrative

(b)(4).The event is currently under investigation.

Manufacturer Narrative

(b)(4).Investigation- a review of the complaint history, instructions for use (ifu) and quality control (qc) was conducted for the purpose of this investigation.Product was not returned and photos were not provided.The attempts to contact the customer were not answered.The 4 years difference between the implant and explant date ((b)(6) 2011 - (b)(6) 2015) suggests that there was no problem with the implant sterility (otherwise this presumably infected graft would of probably manifested earlier).Probably the eventual infection of the graft was due to the patient condition and other associated disease (which might be of infectious nature).The ifu advises the healthcare provider to monitor the patient with a aaa graft implant: section 12.1: "patients should be counseled on the importance of adhering to the follow-up schedule, both during the first year and at yearly intervals thereafter.Physicians should evaluate patients on an individual basis and prescribe their follow-up relative to the needs and circumstances of each individual patient.".From the description of the event it looks like the patient was under constant monitor which allowed his physician to decide the best timing for explant.The conclusion is that most probably this event is due to the aneurysm growth and eventual patient infection so the root cause of this event is procedure related / patient condition related to occurrence.Instructions are in place to verify the device is manufactured within specifications.We will continue to monitor for similar complaints.The risk remains acceptable per a quality engineer risk assessment conducted.No additional action is required at this time.

Event Description

An (b)(6) male patient undergoes surgery for removal of the main body graft due to disease progression.The aneurysm was still growing and the graft was possibly infected.The graft was only partially removed.The suprarenal bare metal stent was left in place.The explant was a re-intervention.The patient had open repair and his aorta was reconstructed with a sown in graft.The patient is recovering after the procedure.No additional information has been provided.

• Brand Name: ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY
• Type of Device: MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): COOK, INC.; bloomington IN 47404
• Manufacturer Contact: rita harden ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 4874997
• MDR Text Key: 5861891
• Report Number: 1820334-2015-00374
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P020018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,health professional,use
• Reporter Occupation: Physician Assistant
• Type of Report: Initial,Followup
• Report Date: 05/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2013
• Device Model Number: N/A
• Device Catalogue Number: TFFB-30-111-ZT
• Device Lot Number: 2777217
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/26/2015
• Device Age: 46 MO
• Event Location: Hospital
• Initial Date Manufacturer Received: 05/29/2015
• Initial Date FDA Received: 06/25/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/30/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/18/2011
• 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): Hospitalization; Required Intervention
• Patient Age: 81 YR