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

Catalog Number TFFB-22-82-ZT

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

Patient Problem Unspecified Infection (1930)

Event Date 03/10/2014

Event Type  Injury  

Event Description

A study indicated that a (b)(6) female patient underwent evar for aaa on (b)(6) 2014.Maximum aortic aneurysm diameter was listed as 20.8 mm and inner diameter of the aorta just above the aortic bifurcation was 6.0 mm, and of the right iliac was 7.4 mm.The proximal neck was parallel in shape with no plaque or thrombus.There was no difficulty deploying any of the devices (one zenith flex main body and two zenith iliac leg grafts with spiral-z technology).A molding balloon was used during the study procedure.Uncovered stents were placed in both iliac legs at the time of the procedure due to occlusion (1820334-2014-00159).The completion angiogram showed that the devices were patent, with no evidence of external compression, kinks, thrombus, or endoleaks.On (b)(6) 2014 (21 days post-procedure), the patient was admitted to the hospital due to a wound infection from the evar procedure.The patient had been placed on cipro 1 week earlier but the wound was "looking worse".After admission, the patient was to receive levaquin and flagyl.During the initial infusion of levaquin, the patient began having respiratory distress and became hypotensive.The infusion was stopped, the patient was given 100 mg of hydrocortisone, and placed on a nonrebreather o2 mask.She then developed rapidly progressive bilateral lower extremity pains and pulses could not be palpated.A stat ultrasound showed occlusion of the right lower extremity arterial system extending from at least the common femoral artery down.The left side could not be imaged.The patient was taken urgently to the operating room for a bilateral iliofemoral thromboembolectomy with left femoral endarterectomy with patch angioplasty.The right iliofemoral endarterectomy was closed with primary repair.Hematology consultation on (b)(6) 2014 (22 days post-procedure) indicated "thrombosis of the aortic and iliac graft (1820334-2014-00159).This was probably triggered by a combination of recent surgery and hypotension.She probably also has peripheral vascular disease from her smoking, hypertension, and hyperlipidemia." multiple lab tests were to be checked in order to rule out any intrinsic hypercoagulable state - none of those results are available.District manager spoke to physician (b)(6) 2014 providing the following additional information: the physician said that he did not believe this had anything to do with the graft.The physician said he thought the patient developed a clot in the lower extremity that worked its way upward because they lost pulses in the lower extremities.The physician also said he thought it was related to the antibiotics given and that the patient had some sort of allergic reaction that triggered their blood to clot.The physician told the district manager that he felt the graft was patent and there were no limb kinks because after he and the other physician had performed the bilateral iliofemoral thromboembolectomy, bilateral distal pulses were restored.The physician did not feel an angiogram was needed at the time to look at the graft.As of (b)(6) 2014 patient is recovering.

Manufacturer Narrative

(b)(4).Event evaluation: still under investigation.

• 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, director ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 3980824
• MDR Text Key: 4822813
• Report Number: 1820334-2014-00307
• 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: Study
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2015
• Device Catalogue Number: TFFB-22-82-ZT
• Device Lot Number: 4501828
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/10/2014
• Device Age: 6 MO
• Event Location: Hospital
• Date Manufacturer Received: 06/24/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/18/2013
• 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: 77 YR