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

Catalog Number TFFB-24-111-ZT

Device Problems Leak/Splash (1354); Material Rupture (1546)

Patient Problem No Code Available (3191)

Event Date 03/23/2016

Event Type  Injury  

Manufacturer Narrative

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

Event Description

During an evar in the abdominal aorta on a (b)(6) year old male patient, after implanting all the limbs in the final run, the clinical specialist and physician discovered a type ii and type iii endoleak.The physician performed a selective angio and was able to confirm the type iii.The physician and clinical specialist believe that there is a tear in the fabric, or couple of the sutures in the main body above the flow divider, were broken.The physician attempted to fix it by implanting additional limbs, but to no effect.It was not until the physician decided to realign it with a bifurcated graft (another manufacturer).After implanting the graft, the type iii endoleak stopped.Additional information has been requested regarding patient outcome.

Manufacturer Narrative

A review of the complaint history, device history record, instructions for use (ifu), manufacturing instructions, specifications, trends, and quality control was conducted during the investigation.The complaint device was not returned; therefore no physical examination could be performed.However, a document-based investigation was performed.There is no evidence to suggest the finished product was not made to specifications.Review of the device history record of the finished product shows no nonconforming events that would contribute to this failure mode.There were no other reported complaints for this lot number.According to the imaging review, there were numerous suture holes and possibly a type 1a and 1b endoleak.There were suture holes in the right limb, the proximal seal zone, and in the left superior distal main body stent.The distal main body stent was expanded to 28.5 mm right to left and the adjacent stents were constrained to 25 mm.This expansion was beyond the stent design and most likely occurred due to aggressive molding balloon angioplasty.This expansion created a step-off between the left lateral distal main body stent and the superior stent; this is where the complaint endoleak, also the most prominent in this device, occurred.This leak was most prominent likely because the fabric around the suture hole was stretched due to the aggressive molding balloon inflation at the left limb gate.Multiple suture leaks are associated with iliac outflow limitation and use of anticoagulation, both of which were present here.External iliac artery outflow was limited on the right and possibly the left, which increases the likelihood of provoking the suture holes due to increased pressure.Anticoagulation is standard according to the ifu.Imaging review also noted that the small suture hole endoleaks decreased over time, and case completion relieves outflow obstruction and stops the use of anticoagulant.Suture hole leaks are not due to a defective device in most cases, but are due to transient conditions, like iliac artery outflow limitation and aggressive anticoagulation.Injection within the endograft also makes it appear that the suture hole endoleaks are more prominent.The root cause of this issue is likely procedure-related and/or patient condition-related.However, based on the information provided, no product returned, and the results of our investigation; a definitive root cause cannot be determined.Per the quality engineering risk assessment, no further action is warranted.Monitoring will continue to be performed for similar complaints.

Event Description

During an endovascular aneurysm repair in the abdominal aorta on a (b)(6) male patient, after implanting all the limbs in the final run, the clinical specialist and physician discovered a type ii and type iii endoleak.The physician performed a selective angio and was able to confirm the type iii.The physician and clinical specialist believe that there is a tear in the fabric, or a couple of the sutures in the main body above the flow divider were broken.The physician attempted to fix it by implanting additional limbs, but to no effect.After realigning it with a bifurcated graft from another manufacturer, the type iii endoleak stopped.There were reportedly no adverse effects on the patient due to this occurrence.

• 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; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 5586683
• MDR Text Key: 42973655
• Report Number: 1820334-2016-00286
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 10827002484099
• UDI-Public: (01)10827002484099(17)171121(10)6375953
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: TFFB-24-111-ZT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/23/2016
• Device Age: 5 MO
• Event Location: Hospital
• Date Manufacturer Received: 06/13/2017
• Date Device Manufactured: 11/21/2015
• 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: 61 YR
• Patient Weight: 90