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
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/08/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).This event is currently under investigation.
Event or Problem Description
On (b)(6) 2016, a (b)(6)-year-old male patient underwent evar for aaa.The patient was suitable for the procedure.After stent graft placement was conducted as planned, the confirmatory angiography confirmed massive type iv endoleak.However, the procedure was finished without additional treatment, and the physician decided to take a wait-and-see approach.There have been no adverse effects to the patient reported.
Additional Manufacturer Narrative
Investigation - evaluation: a review of the complaint history, device history record, documentation, instructions for use (ifu), specifications, trends, quality control and imaging review was conducted during the investigation.Imaging review: impression: 1.A type iv endoleak is not confirmed.A type iv endoleak is defined as diffuse transfabric flow from graft porosity.This has not been observed consistently from a device since the original gore excluder fabric was replaced with a low-permeability ptfe.2.Sporadic cases of what is misinterpreted as a type iv endoleak do occur.This is likely an example.First and most importantly, the endoleak resolved with procedural physiologic changes provoking endoleak were no longer present.Acute endoleaks that resolve are provoked by anticoagulation and factors that transiently increase the intra-graft to sac pressure gradient.In this case, anticoagulation, likely aggressive, was necessary to prevent access artery thrombosis and the intra-graft to sac pressure gradient was increased by a robust completion angiogram and limited outflow.3.Although not the primary endoleak, only a contralateral gate type iiia endoleak could be unmistakably identified on the provided imaging.This endoleak was minor in comparison to the early larger endoleak in the proximal sac.4.The proximal sac endoleak was most likely a type ia endoleak through sealing stent pleating rather than multiple provoked type iii suture hole endoleaks.First, enough graft oversizing relative to the aortic lumen was present to create pleats.Second, the leak started in the proximal sac rather than diffusely.Third, lumbar artery filling at mid sealing stent level, although slowed, demonstrated that some blood flow around the sealing stent was still present at completion.5.Ignoring the endoleak's proximal origin, the impression of contrast flowing through the fabric on the completion angiogram is undeniable.However, a different angiogram showed that contrast swirling in the sac anterior and posterior to the endograft produced the same appearance.Hence the visual impression was more likely produced by a type ia endoleak, a much more probable source.6.Significant finding relative to the patient's anatomy were not observed.7.Significant finding relative to the disease state were not observed.8.Significant finding relative to the use of the device were observed.Although the endograft may have been 20% oversized the aortic outer diameter, acutely in regards to pleating only the aortic lumen diameter mattered and this was 40%.Consequently the potential for a transient type ia endoleak was elevated.9.Significant finding relative to the design or performance of the device were not observed.10.Cause of adverse events was not observed." the complaint device was not returned therefore, no physical examinations could be performed; however, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.The lot number of the device is not known; accordingly a review of the device history record could not be conducted.Each zenith device is shipped with instructions for use (ifu) t_zaaaf_rev4, listing the indications for use, contraindications, warnings and precautions, and the correct deployment procedure.Potential adverse events that may occur and/or require intervention include, but are not limited to endoleak.Based on the information provided and results of the investigation, a definitive root cause could not be determined.Per the quality engineering risk assessment no further action is required.We will continue to monitor for similar complaints.

• Brand Name: ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY
• Common Device Name: MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 5962804
• Report Number: 1820334-2016-00994
• Device Sequence Number: 681407
• Product Code: MIH
• UDI-Device Identifier: 10827002484020
• UDI-Public: (01)10827002484020(17)170814(10)6052939
• Combination Product (Y/N): N
• PMA/510(K) Number: P020018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: TFFB-22-82-ZT
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/22/2016
• Supplement Date Received by Manufacturer: 06/15/2017
• Initial Report FDA Received Date: 09/20/2016
• Supplement Report FDA Received Date: 07/12/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 67 YR