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

Device Problem Leak/Splash (1354)

Patient Problem Other (for use when an appropriate patient code cannot be identified) (2200)

Event Date 01/16/2015

Event Type  Injury  

Event Description

This (b)(6) male pt in the (b)(4) had a type iii endoleak at the conclusion of the deployment procedure on (b)(6) 2015.The pt was being treated for an aortoiliac aneurysm with a maximum aortic aneurysm diameter of 30 mm.The proximal neck had a parallel shape with no plaque/thrombus.The bilateral iliac arteries had severe tortuosity, mild calcification, and no occlusive disease.The pt received a cook proximal main body device, a left iliac leg device, a right iliac leg device, a left iliac leg extension, and a right iliac leg extension.There was no difficulty deploying any of the components.A molding balloon was used but no details were provided regarding its use.After the procedure, one covered iliac artery stent was placed in the leg/leg extension in the left iliac and one covered iliac artery stent was placed in the leg/leg extension in the right iliac.At the conclusion of the procedure, the devices were patent with no external compression, flow-limiting kinks, or thrombus.A type iii endoleak was noted.The subtype of the type iii was noted as graft overlap joint in the left iliac leg, right iliac leg, left iliac leg extension and right iliac leg extension.

Manufacturer Narrative

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

Manufacturer Narrative

During investigation, a review of complaint history, instructions for use (ifu), quality control, device specifications, and trends was conducted.This complaint involves 4 devices each of differing diameter/length combinations.None of these complaint devices were returned, no images were provided and no pt ct or additional case data to support the complaint were provided.Since the procedure took place in (b)(6) 2015, it is possible that case data may be provided by the customer.The procedure took place on (b)(6) 2015 for treatment of an aortoiliac aneurysm using a tffb-24-74, a left iliac leg device, a right iliac leg device a left iliac leg extension, and a right iliac leg extension.There was no difficulty deploying any of the components.Balloon molding angioplasty was used but no details were provided at which joints.One covered iliac artery stent was placed in the leg/leg extension in the left iliac and one covered iliac artery stent was placed in the leg/leg extension in the right iliac, after the initial zenith platform was deployed.It is unclear what took place between the deployment of the zenith platform and these covered stents.At the conclusion of the overall procedure, the devices were patent with no external compression, flow limiting kinks, or thrombus.A type ii endoleak was noted and determined to be type 3a as graft overlap joint in the left iliac leg, right iliac leg, ;eft iliac leg extension and right iliac leg extension.No information has been provided about the lot numbers of the complaint devices so the manufacturing record could not be looked up for these specific devices.A review of the ifu (this ifu corresponds to all 4 complaint devices) states at the very beginning of the english section on page 16, "read all instructions carefully.Failure to properly follow the instructions, warnings and precautions may led to serious surgical consequences or injury to the pt." section 4.2 of the ifu states, ".Vessels that are significantly calcified, occlusive, tortuous or thrombus lined may preclude placement of the endovascular graft." a "note" in section 11 1.4 states, "in tortuous vessels the anatomy may alter significantly with the introduction of the rigid wires and sheath systems." as reported by the customer, the bilateral iliacs had "severe" tortuosity and may have played a significant role in the developement of the type 3 endoleak.It is likely that the endoleak is a type 3a, junction/joint separation.Taking into account the severe tortuosity, it is likely that even with the additional covered stents that were used bilaterally, the type 3a endoleak would not be able to be resolved and thus persisted.With the use of the covered stents bilaterally, the customer may already have been aware that sealing between the zsle devices would not be sufficient considering the tortuosity and the customer prophylactically utilized covered stents in addition to the zsles already in place.Without additional clinical information, evaluation and ct data, it is difficult to ascertain a root cause for the endoleak.Possible sources could be but are not limited to excessive pressure due to modeling balloon angioplasty, incorrect sizing and placement of the device, insufficient sealing of the device to the anatomy due to severe tortuous iliac anatomy, off-label use due to severe vessel tortuosity.We will continue our monitoring of similar complaints and have notified the appropriate internal personnel of this event.

• 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: 4745993
• MDR Text Key: 21081646
• Report Number: 1820334-2015-00279
• 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: User Facility,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/16/2015

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
• Distributor Facility Aware Date: 01/16/2015
• Device Age: NA
• Event Location: Hospital
• Initial Date Manufacturer Received: 04/17/2015
• Initial Date FDA Received: 04/27/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/07/2015
• 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 ILIAC LEG EXTENSION - ZSLE-20-90-ZT; LEF ILIAC LEG DEVICE - ZSLE-13-90-ZT; LEFT ILIAC LEG EXTENSION - ZSLE-20-74-ZT; RIGHT ILIAC LEG DEVICE - ZSLE-13-74-ZT
• Patient Outcome(s): Other
• Patient Age: 78 YR