MAUDE Adverse Event Report: COOK, INC. UNKNOWN; MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Device Problem Kinked (1339)

Patient Problem Surgical procedure, additional (2564)

Event Type  Injury  

Event Description

On (b)(6) 2015, a separate event was noted to be reportable during the investigation.Information was provided in (b)(6) endovascular symposium held in (b)(6) from (b)(6) 2014 to (b)(6) 2014.A patient had undergone aaa repair.During a 2-year follow-up (around 2012), it was confirmed that the iliac leg graft in the right side migrated into the aaa and located on the bifurcation of the main body (1820334-2014-00468).The iliac leg in the left side was kinked to the centrum side (subject of this report).Additional stent grafts were placed on both the right and left sides to address the migration and kink (1820334-2015-00341).There have been no adverse effects reported to date.No additional information has been provided by the reporter.

Manufacturer Narrative

(b)(4).A review of the complaint history, instructions for use (ifu) and trends was conducted for the purpose of this investigation.No product or imaging were returned to assist with this investigation.Limited information was provided as well.Zenith ifu about calcified and tortuous anatomy precluding placement of zenith devices and possible secondary treatment may be necessary.The failure mode assigned to this case is kinked.By report during two years after an endovascular procedure using a zenith leg device, the left leg graft was noted to be kinked and required placement an additional stent to maintain lumen patency.Based on the information a definitive root cause can not be determined or reported at this time.The risk remains at an acceptable level with inclusion of this event.Additional action is not required at this time.We will continue to monitor for similar complaints and notify the appropriate internal personnel.

• Brand Name: UNKNOWN
• Type of Device: MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): COOK, INC.; bloomington IN 47404
• Manufacturer Contact: larry pool,mgr ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 4821438
• MDR Text Key: 5837939
• Report Number: 1820334-2015-00341
• Device Sequence Number: 1
• Product Code: EZL
• 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,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/28/2014,05/04/2015

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Initial Date Manufacturer Received: 05/04/2015
• Initial Date FDA Received: 06/02/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: RIGHT SIDE ILIAC GRAFT
• Patient Outcome(s): Required Intervention