MAUDE Adverse Event Report: COOK INC ZENITH RENU AAA ANCILLARY GRAFT CONVERTER; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT, MIH

Catalog Number AX1-1-32-108-ZT

Device Problem Leak/Splash (1354)

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

Event Date 02/28/2015

Event Type  Injury  

Event Description

The district manager was called in to the facility for an emergent rupture on a (b)(6) year old female patient.After implanting the device, a run was performed and the user discovered a type 3 endoleak.It was noted that there was a tear in the fabric between the second and third stent.An additional graft was placed.The facility will keep a close eye on the patient and bring her back routinely.

Manufacturer Narrative

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

Manufacturer Narrative

The zenith device has completed design control requirements demonstrating that the device meets the predetermined requirements and that the requirements meet the needs of the user.The device history record was reviewed and found unremarkable.Each zenith renu device is shipped with an ifu.This document includes instructions for use, contraindications, warnings and precautions regarding use of this device.Statements regarding the risk and management of endoleaks and other potential adverse events are included.Specifically."additional endovascular interventions or conversion to standard open surgical repair following initial endovascular repair should be considered for patients experiencing an enlarging aneurysm, unacceptable fixation length (both the vessel and component overlaps) and/or endoleak.An increase in aneurysm size and/or persistent endoleak or migration may lead to aneurysm rupture patients experiencing reduced blood flow through the graft and/or leaks may be required to undergo secondary interventions or surgical procedures.Patients with specific clinical findings (e.G.Endoleaks, enlarging aneurysm or changes in the structure or position of the endovascular graft) should receive enhanced follow-up." "strict adherence to the zenith renu aaa ancillary graft ifu sizing guide is strongly recommended when selecting the appropriate device size (tables 10.5.1 through 10.5.2).Appropriate device oversizing has been incorporated into the ifu sizing guide sizing outside of this range can result in endoleak, fracture, migration, device infolding or compression." the complaint and associated correspondence includes the information that this device was placed as a primary (emergent) intervention, which is contraindicated in the ifu.No adverse effects subsequent to the endoleak resolution procedure were noted.Images were received and sent for external clinical review.From the two angiographic monitor still images and the report narrative, he determined that the abdominal aorta was severely irregular (20 mm maximum, with irregular plaque narrowing it further) with a likely pseudoaneurysm and a likely occluded left iliac.Following placement of the renu device, but prior to placement of the other manufacturer's component, the imaging showed contrast present outside the endograft just inferior to the diameter reducing stent, with the sealing stent expanded to 20 mm, possibly partially covering the lra.Two limbs were used to extend into the ria.The reviewer concluded that the leak could possibly have been a type iii (as reported) but was more likely to have been a type ia, owing to 60% oversizing.Use of two short leg grafts to get from the renu to the ria suggests that the range of available device sizes on hand could have been inadequate to the situation.He noted that the only appropriate component (of the other manufacturer) was the cuff, which may have eliminated the endoleak by flattening the pleats caused by the oversizing.Other information contained in the complaint is consistent with this possibility.In either case, this device was used in a primary intervention, therefore off-label.Physicians may use devices off-label at their discretion.We will continue our monitoring of similar complaints and have notified the appropriate personnel of this event.

• Brand Name: ZENITH RENU AAA ANCILLARY GRAFT CONVERTER
• Type of Device: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT, MIH
• Manufacturer (Section D): COOK INC; bloomington IN 47404
• Manufacturer Contact: larry pool, manager ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 4626988
• MDR Text Key: 5592619
• Report Number: 1820334-2015-00162
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 10827002553863
• UDI-Public: (01)10827002553863(17)160701(10)4395345
• 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: Company Representative,company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/28/2015

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: 07/01/2016
• Device Catalogue Number: AX1-1-32-108-ZT
• Device Lot Number: 4395345
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/28/2015
• Device Age: 19 MO
• Event Location: Hospital
• Initial Date Manufacturer Received: 03/02/2015
• Initial Date FDA Received: 03/19/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/21/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2013
• 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: 69 YR