MAUDE Adverse Event Report: COOK INC ZENITH AAA ENDOVASCULAR GRAFT ILIAC LEG; MIH SYSTEM, ENDOCASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Catalog Number TFLE-12-88

Device Problem Leak/Splash (1354)

Patient Problem Surgical procedure, additional (2564)

Event Date 04/07/2015

Event Type  Injury  

Event Description

A (b)(6) male pt had grafts implanted in 2009.The leg extension separated from the main body on the contralateral side creating a type 3 endoleak.An additional graft was placed to realign due to the endoleak.No information has been provided regarding pt outcome.

Manufacturer Narrative

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

Manufacturer Narrative

During investigation, a review of complaint history, information for use (ifu), quality control (qc), specifications and trends was conducted.Based on the information provided, the iliac leg graft separated from the main body resulting in a type 3 endoleak.Initial implantation was in 2009.The endoleak/separation was treated with placement of an iliac leg graft.The district manager commented that he felt the iliac leg caused the separation, but no other details were provided.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 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.The iliac leg grafts are 100% inspected to confirm correct stents have been used and have been placed correctly on the graft and to confirm that the entire graft has no damage, foreign matter, frays, or holes except for suture entry and exit points.No lot number was provided, therefore, a review of the manufacturing records could not be conducted.Without additional information, a definitive root cause cannot be established.The appropriate internal personnel have been notified.We will continue to monitor for similar events.

• Brand Name: ZENITH AAA ENDOVASCULAR GRAFT ILIAC LEG
• Type of Device: MIH SYSTEM, ENDOCASCULAR 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: 4745935
• MDR Text Key: 19995437
• Report Number: 1820334-2015-00274
• 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: 04/07/2015

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 Catalogue Number: TFLE-12-88
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/07/2015
• Device Age: NA
• Event Location: Hospital
• Initial Date Manufacturer Received: 04/09/2015
• Initial Date FDA Received: 04/27/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/22/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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