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 Problem Leak/Splash (1354)

Patient Problems Aneurysm (1708); Surgical procedure, additional (2564)

Event Date 06/30/2015

Event Type  Injury  

Event Description

A (b)(6) male underwent an abdominal aortic aneurysm repair.The device had a tear that was noted upon initial implant, which resulted in a type ii endoleak.The physician added a cuff and remedied the leak.No harm to the patient.The patient is currently in the hospital.

Manufacturer Narrative

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

Manufacturer Narrative

(b)(4).Event evaluation: a review of complaint history, device history record and instructions for use (ifu) was conducted during the investigation.The product or medical imaging was provided for review; however, the sizing worksheets were provided.The device history record was reviewed and was without indication of a quality issue.The zenith device has completed design control requirements demonstrating that the device meets the predetermined requirements and that the requirements meet the needs of the user.Specifically, design verification testing included water permeability testing, migration resistance testing, and radial force testing.The results met the acceptance criteria.The ifu provides instructions for use, contraindications, warnings and precautions regarding the appropriate method of use.Specifically, it states "additional endovascular interventions or conversion to standard open surgical repair following initial endovascular repair should be considered for patients experiencing an enlarging aneurysm, unacceptable decrease in fixation length (vessel and component overlap) and/or endoleak.An increase in aneurysm size and/or persistent endoleak or migration may lead to aneurysm rupture.Patients experiencing reduced blood flow through the graft limb and/or leaks may be required to undergo secondary interventions or surgical procedures." based on the information available about the observed endoleak, no definitive conclusion can be reached about the cause for this event.The appropriate internal personnel will be notified and we will continue to monitor for similar complaints.Based on the risk assessment performed, no additional actions are required at this time.

Event Description

A (b)(6) male underwent an abdominal aortic aneurysm repair.The device had a tear that was noted upon initial implant; which resulted in a type iii endoleak.The physician added a cuff and remedied the leak.No harm to the patient.

• 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; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 4947279
• MDR Text Key: 6189943
• Report Number: 1820334-2015-00439
• 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: Company Representative,company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/30/2015

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: 03/20/2017
• Device Model Number: N/A
• Device Catalogue Number: TFFB-30-96-ZT
• Device Lot Number: 5716770
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/30/2015
• Device Age: 3 MO
• Event Location: Hospital
• Initial Date Manufacturer Received: 07/01/2015
• Initial Date FDA Received: 07/22/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/23/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/25/2015
• 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): Required Intervention
• Patient Age: 72 YR