MAUDE Adverse Event Report: COOK INC ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG; MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Model Number	N/A
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	09/02/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.(b)(4).The event is currently under investigation.
Event or Problem Description
An (b)(6) male patient underwent a aaa repair in (b)(6) 2016.The patient's anatomical form was suitable for the procedure.After placing all stent grafts as planned, an excessive amount of type iv endoleak was confirmed by final angiography.Another stent graft was implanted.No further information was provided regarding patient outcome.There have been no adverse effects to the patient reported as of the date of this report.The initial report for this event was filed under med-watch# 1820334-2016-01064, additional information was provided on (b)(6) 2016 regarding the specific devices.Two additional complaints were opened to address the additional products and med-watch reports initiated under: med-watch# 1820334-2016-01429 for part zsle-20-90-zt.Med-watch# 1820334-2016-01430 for part zsle-24-74-zt (this report)0.
Additional Manufacturer Narrative
Investigation - evaluation: a review of the complaint history, device history record, documentation, instructions for use (ifu), specifications, trends and imaging review was conducted during the investigation.The findings part of the imaging review file states: "a video recording of an angiography monitor playing a single completion angiogram was provided along with the complaint report.Performed by pigtail injection in the proximal mainbody, the angiogram demonstrated numerous tiny jet-like endoleaks through the mainbody fabric as well as each limb.The sac was very large, at least 6.5cm diameter right to left and free of thrombus.A type ii endoleak also flowed into the sac through the left 4th lumbar artery.More graft components than just a zsle were present at the end of the right leg component.The type of extension cannot be determined".The impressions part of the imaging review file states: "numerous suture hole endoleaks were confirmed.These are classified as type ill endoleaks and not type vi endoleaks which represent diffuse trans fabric leak.Diffuse trans fabric leak was not observed.A number of factors likely contributed.First, the injection was performed directly into the sac creating a momentary pressure wave.Second, the sac contents were still fluid, not even partial thrombosis had developed.The patient was likely still highly anti-coagulated.Finally, the arterial to sac pressure gradient was high enough to drive type ii endoleak flow into the sac.The patient may have been significantly hypertensive.The suture hole endoleaks will likely resolve"."significant findings relative to the patient's anatomy were not observed.Significant findings relative to the disease state were observed.The sac was very large and fluid filled rather than even partially thrombosed.The arterial to sac pressure gradient was high enough to favor type ii flow into the sac despite the suture hole endoleaks.Significant findings relative to the use of the device were observed.The completion angiogram was performed directly into the mainbody rather than in the suprarenal abdominal aorta.Significant findings relative to the design or performance of the device were observed.Numerous suture hole endoleaks were observed.These will likely resolve.Cause of adverse events was not observed".Document review was conducted and no anomalies related to the event were noted.This complaint is the only one associated to the complaint lot number due to this product only having one per lot.The user and sales rep suggested that the graft material had changed, however we can confirm that there was no change to the material.Each zenith device is shipped with instructions for use, listing the indications for use, contraindications, warnings and precautions, and the correct deployment procedure.Potential adverse events that may occur and/or require intervention include, but are not limited to: endoleak.Suture hole endoleaks are associated with increased pressure within the grafts, possibly due to outflow limitation or inner graft angiogram injections, and aggressive anticoagulation use.Based on the information provided and results of the investigation the most likely root cause may be related to the procedure and the patient's preexisting condition.Per the quality engineering risk assessment no further action is required.We will continue to monitor for similar complaints.

• Brand Name: ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG
• Common Device Name: MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6152025
• Report Number: 1820334-2016-01430
• Device Sequence Number: 844230
• Product Code: MIH
• UDI-Device Identifier: 10827002552460
• UDI-Public: (01)10827002552460(17)190329(10)6830117
• Combination Product (Y/N): N
• PMA/510(K) Number: P020018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/12/2017

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
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: ZSLE-24-74-ZT
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/14/2016
• Supplement Date Received by Manufacturer: 06/14/2017
• Initial Report FDA Received Date: 12/07/2016
• Supplement Report FDA Received Date: 07/12/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 84 YR