MAUDE Adverse Event Report: COOK INC ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG; MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Model Number	N/A
Medical Device Problem Codes	Leak/Splash (1354); Material Rupture (1546); Material Separation (1562)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	08/25/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.
Event or Problem Description
It was reported that a (b)(6) year old male underwent a fenestrated endovascular abdominal aortic aneurysm repair procedure.A type 3 endoleak was observed and thought to be caused by a graft tear.After deployment of the device with a 2.2 cm of overlap inside the contralateral gate of the device and almost 3cm plus overlap inside of another manufacturer's self-expanding stent.The competitor's device was ballooned with the 7mm x 40mm angioplasty balloon.The balloon catheter was then used to balloon mold the proximal overlap (inside the device's distal body) and the distal overlap segment (inside the competitor's device).A final angiogram revealed contrast coming outside of the two stent grafts (9x107 and 8x10cm) precisely at the most proximal level of the competitor's device where the device began its overlap.The physicians believed that the leak was the result of a type 3 endoleak caused by a graft tear.Therefore, the decision was made to use a 10x5cm competitor's device in hopes that this would resolve the leak.The 10x5cm stent graft was deployed.However, the leak remained.The physician decided to use another 9x107 device to re-align the first 9x107 device.Introduction and deployment of these devices were fine.However, withdrawal of the delivery system was difficult as the dilator was getting stuck inside the 8x10cm distal competitor's device.The 9x107 device was finally able to be taken out.The competitor's 12fr x 28 sheath was used to shoot an antegrade contrast through the lt limb.The angiogram did not reveal any additional distal contrast outside the stent grafts.However, there now appeared to be some type of leak at the most proximal overlap of the first 9x107 device.The decision was made to not address or treat the leak at this time.The patient's condition is unknown was not provided.
Additional Manufacturer Narrative
(b)(4).A review of the complaint history, device history record, instructions for use (ifu), trends, quality control, and imaging review was conducted during the investigation.Imaging review: findings : there is previous placement of a zfen stent graft device for treatment of a juxtarenal aortic aneurysm.There is also placement of competitor stent grafts in bilateral external iliac arteries, overlapping with bilateral iliac leg devices"."there is complete occlusion of the left iliac limb with no flow throughout the left common and external iliac stent graft devices.There is severe calcification of the outflow external iliac artery just distal to the competitor stent, resulting in a measured luminal diameter of 4.8 mm.This could result in outflow obstruction and subsequent thrombosis.There is also a slight shelf-type bend at the junction of the distal zsle leg in the competitor stent, which could also be causing some outflow disturbance.Finally, the overlap segment of the multiple stent graft devices has led to significant luminal diameter narrowing.The outer diameter of the devices at this level is 9 mm.However, the multiple layers of graft material have caused significant internal diameter reduction to 4.5 mm.All three of the findings could contribute to limb thrombosis due to flow reduction".There is no evidence to suggest the product was not made to specifications.Review of device history record shows no nonconforming events which could contribute to this failure mode.It should be noted there were no other reported complaints for this lot number.The device is shipped with an instruction for use (ifu) that describes the indications for use, contraindications, warnings, precautions, and correct deployment procedure.Inaccurate placement and/or incomplete sealing of the zenith spiral-z aaa iliac leg within the vessel may result in increased risk of endoleak, migration or inadvertent occlusion of the iliac arteries.Inadequate overlap of the zenith spiral-z aaa iliac leg may result in increased risk of migration of the stent graft.Incorrect deployment or migration of the endoprosthesis may require surgical intervention.As the sheath and/or wire guide is withdrawn, anatomy and graft position may change.Constantly monitor graft position and perform angiography to check position as necessary." based on the information provided, no product returned, and the 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.
Event or Problem Description
It was reported that after deployment of the zenith flex with spiral-z leg extension and competitor stent graft for endovascular aneurysm repair (evar), final angiogram results revealed contrast coming outside of the two stent grafts at the most proximal level where the competitor and manufacturer grafts began to overlap.The physician believed the leak was the result of a type 3 endoleak due to graft tear.A 10x5 cm competitor graft was placed but was unsuccessful in resolving the leak.The physician then decided to use another 9x107 extension to re-align the first 9x107 device.Introduction and deployment of these devices were successful; however, withdrawal of the delivery system was difficult as the dilator was getting stuck inside the distal 8x10 cm device.The competitor device was finally removed and a 12 french (fr) x 28 sheath was used to shoot antegrade contrast through the left limb.Angiogram results confirmed no distal contrast outside the stent grafts however, there now appeared to be leak at the most proximal overlap of the first 9x107 device.No intervention was performed for the leak at this time.The patient was last reported to be "fine" and was discharged home.

• Brand Name: ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG
• Common Device Name: MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 5970149
• Report Number: 1820334-2016-01000
• Device Sequence Number: 441309
• Product Code: MIH
• UDI-Device Identifier: 10827002552224
• UDI-Public: (01)10827002552224(17)170721(10)5130555
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P020018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/17/2017

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?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: ZSLE-9-107-ZT
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/25/2016
• Supplement Date Received by Manufacturer: 06/29/2017
• Initial Report FDA Received Date: 09/22/2016
• Supplement Report FDA Received Date: 07/17/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GORE VIABAHNCODA BALLOON
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 75 YR
• Patient Weight: 82