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

Model Number N/A

Device Problems Occlusion Within Device (1423); Other (for use when an appropriate device code cannot be identified) (2203)

Patient Problems Ischemia (1942); No Code Available (3191)

Event Date 01/14/2015

Event Type  Injury  

Event Description

A (b)(6) male patient was treated on (b)(6) 2015 for an aortic aneurysm.The maximum aortic diameter was 50 mm.The proximal neck had an irregular shape with complete plaque/thrombus.The right iliac artery had moderate tortuosity, no occlusive disease, and mild calcification.The left iliac artery had severe tortuosity, mild occlusive disease, and mild calcification.The patient received a main-body device, a left iliac leg, and a right iliac leg.There was no difficulty deploying any of the components.No other procedures were performed and no additional devices were used.A molding balloon was used but no details were provided regarding its use.At the conclusion of the procedure, the devices were patent with no external compression, flow-limiting kinks, endoleaks, or thrombus.On (b)(6)2015 (5 days post procedure), the patient experienced bowel obstruction, ischema or fistula.No other information regarding the event is available.On (b)(6) 2015 (123 days post-procedure), the patient was seen in follow-up.There had been no change in the size of the aneurysm.Devices were patent with no external compression, flow limiting kinks, thrombus, migration or endoleaks.No other follow up visits were reported.

Manufacturer Narrative

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

Manufacturer Narrative

Event evaluation: a review of complaint history, instructions for use (ifu), and trends was conducted during the investigation.This product line has addressed all design control requirements and shown the device has met the predetermined requirements and that those requirements meet the needs of the user.Each device is sent with an ifu, which describes the indications for use, warnings, precautions, and the proper deployment sequence.Specific to this case, the ifu states: specific to this case (b)(6) state: "adverse events that may occur and/or require intervention include, but are not limited to:.Claudication (e.G., buttock, lower limb).Embolization (micro an macro) with transient or permanent ischemia or infarction.Genitourinary complications and subsequent attendant problems (e.G., ischemia, erosion, fistula, incontinence, hematuria, infection)" minimal information was provided to assist with this case.It is unclear where the ischemia or fistula occurred or if it was related to pre-existing anatomical conditions or use of the device.There is no evidence to suggest that the device was not manufactured to specification.It was concluded that the failure mode for this case was adverse physiological response.We will continue to monitor for similar complaints.

Event Description

A (b)(6) year old male patient was treated on (b)(6) 2015 for an aortic aneurysm.The maximum aortic diameter was 50 mm.The proximal neck had an irregular shape with complete plaque/thrombus.The right iliac artery had moderate tortuosity, no occlusive disease, and mild calcification.The left iliac artery had severe tortuosity, mild occlusive disease, and mild calcification.The patient received a main-body device, a left iliac leg, and a right iliac leg.There was no difficulty deploying any of the components.No other procedures were performed and no additional devices were used.A molding balloon was used but no details were provided regarding its use.At the conclusion of the procedure, the devices were patent with no external compression, flow-limiting kinks, endoleaks, or thrombus.On (b)(6) 2015 (5 days post procedure), the patient experienced bowel obstruction, ischemia or fistula.No other information regarding the event is available.On (b)(6) 2015 (123 days post-procedure), the patient was seen in follow-up.There had been no change in the size of the aneurysm.Devices were patent with no external compression, flow limiting kinks, thrombus, migration or endoleaks.No other follow up visits were reported.

• 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: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8128294891
• MDR Report Key: 4821448
• MDR Text Key: 19743022
• Report Number: 1820334-2015-00348
• 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: Physician
• Type of Report: Initial
• Report Date: 05/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: TFFB-36-95-ZT
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/14/2015
• Event Location: Hospital
• Date Manufacturer Received: 05/15/2015
• 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): Other
• Patient Age: 93 YR