MAUDE Adverse Event Report: COOK, INC. ZENITH AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY

Catalog Number TFB-26-74

Device Problem Leak/Splash (1354)

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

Event Date 02/13/2015

Event Type  Injury  

Manufacturer Narrative

(b)(6) the event is currently under investigation.

Event Description

This (b)(6) male patient in the spiral-z post-market registry ((b)(4)) had a type iii endoleak at the conclusion of the deployment procedure on (b)(6) 2015.The patient was being treated for an aortoiliac aneurysm with a maximum aortic aneurysm diameter of 31 mm.The proximal neck had a parallel shape with no plaque/thrombus.The left iliac artery had mild tortuosity, mild calcification, and mild occlusive disease.The right iliac artery had moderate tortuosity, mild calcification, and mild occlusive disease.The patient received a cook proximal 26 mm x 74 mm main body device, a 13 mm x 90 mm left iliac leg device, a 13 mm x 74 mm right iliac leg device, a 16 mm x 90 mm left iliac leg extension and a 16 mm x 74 mm 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.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.On (b)(6) 2015 (24 days post-procedure), the patient was seen in follow-up.There had been no change in the size of the aneurysm.The devices were patent with no external compression, flow-limiting kinks, thrombus, migration or endoleaks.The bilateral abi's (ankle-brachial index) were 1.0.The grafts remained inside the patient's body as intended.According to the initial reporter, the patient did not require or experience any adverse effects due to this occurrence.

Manufacturer Narrative

Event eval: for this investigation, the complaint history, instruction for use (ifu), quality control (qc) activities, specifications, and trends were reviewed.None of the (b)(4) complaint devices were returned, no images were provided and no patient ct or additional case data to support the complaint were provided.The procedure took place on (b)(6) 2015 for treatment of an aortoiliac aneurysm using a full body graft (complaint device).In addition a left iliac leg device and extension and a right iliac leg device and extension were used.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.At the conclusion of the procedure, the devices were patent with no external compression, flow-limiting kinks, or thrombus a type 11 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.Currently, no information has been provided about the lot numbers of the iliac devices, however the complaint device lot number was provided.The manufacturing record could not be looked up for the iliac devices, but the complaint device manufacturing record indicates no rework or non-conformances.A review of the both of the ifu for the complaint device and its ancillary components states to read all instructions carefully."failure to properly follow the instructions, warnings and precautions may led to serious surgical consequences or injury to the patient." without additional clinical information, evaluation and computer tomography (ct) data, it is difficult to a certain 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 tortuous iliac anatomy.Appropriate internal personnel have been notified of this event, and continued monitoring of similar complaints will occur.

• Brand Name: ZENITH AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY
• Manufacturer (Section D): COOK, INC.; bloomington IN 47402
• Manufacturer Contact: larry pool, manager ; 750 daniels way; bloomington, IN 47402 ; 8123392235
• MDR Report Key: 4780361
• MDR Text Key: 22228105
• Report Number: 1820334-2015-00277
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 10827002298894
• UDI-Public: (01)10827002298894(17)160807(10)5187098
• 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,Health Professional,User Facility,health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/16/2015,04/15/2015

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: 08/07/2016
• Device Catalogue Number: TFB-26-74
• Device Lot Number: 5187098

Other Device ID Number

• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/13/2015
• Device Age: 7 MO
• Event Location: Hospital
• Initial Date Manufacturer Received: 04/20/2015
• Initial Date FDA Received: 05/14/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/22/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/07/2014
• 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 Age: 63 YR