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

Model Number	N/A
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Codes	Hematoma (1884); No Code Available (3191)
Date of Event	11/02/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant products: cook devices: zpen-p-2-28-124, zpen-d-20-62-94, non-cook devices: medtronic hippocampus renal rx stent 8mm*20mm right renal artery, gore viabahn stent 8mm*25mm left renal artery.(b)(4).This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.
Event or Problem Description
It was reported that after an endovascular repair surgery on a (b)(6) male patient on (b)(6) 2016, a leakage at the junction of an aortic stent (zenith fenestrated aaa endovascular graft distal bifurcated body) and a zenith flex aaa endovascular graft iliac leg (which is the subject of this report) was discovered on (b)(6) 2016 via an emergency angiography performed through femoral artery puncture.The contrast specifically showed leakage between the implanted aortic stent and the right iliac artery.Prior to this, an abdominal ultrasound examination performed on (b)(6) 2016 had suggested a right perirenal hematoma.Two stents from another manufacturer were implanted in the right iliac artery upon discovering the leakage.Intraoperative ultrasound exploration showed no progression of the retroperitoneal hematoma.The femoral artery incision was then closed and the patient showed stable vital signs.However, the patient continued to have gross hematuria and decreased hemoglobin post-surgery which resulted in additional renal and iliac arteriographies on (b)(6) 2016.Contrast leakage was detected at the right renal artery; consequently, renal artery embolization was performed.Following this surgery, the patient retained the implanted urinary catheter but continued to have gross hematuria.On (b)(6) 2016, the patient was diagnosed with acute myocardial infarction as well as acute left heart failure and was treated with medication.The patient was diagnosed with acute pancreatitis at a later time and treated with medication.Since, the patient has been discharged and transferred to a lower level hospital on (b)(6) 2016.The patient remains in the study.It was determined by a cook medical adviser that there is no connection between the endoleak and the problems that occurred, including the myocardial infarction, heart failure, pancreatitis, and hematuria.Additional information regarding patient, device, and event details has been requested but is unavailable at the time of this report.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.H6 ¿ method code: (4114) device not returned.Investigation - evaluation: a representative from (b)(6) hospital notified cook on 25sep2019 of an incident involving a zenith flex aaa endovascular graft iliac leg (tfle-12-90-zt) from lot number 7134510.A 72-year-old patient presented having had an endovascular aneurysm repair (evar) procedure on an abdominal aortic aneurysm (aaa) originally performed on (b)(6) 2016.It was reported a pmcf data collection was ongoing in china for the zenith fenestrated device - global clinical project no.16-09.Abdominal ultrasound examination was performed at 22:40 on (b)(6) 2016, which suggested right perirenal hematoma.At 1:45 on (b)(6) 2016, emergency angiography was performed through femoral artery puncture.The result showed contrast leakage at the junction of aortic stent and right iliac artery.Two stents (medtronic 2613120) were implanted in the right iliac artery.Intraoperative ultrasound exploration showed no obvious progress of retroperitoneal hematoma, and femoral artery incision was closed.The patient's vital signs were stable.The patient continued to have gross hematuria and hemoglobin decreased after surgery, so another renal arteriography and iliac arteriography were performed at 23:00 on (b)(6) 2016.This time the contrast leakage at the right renal artery was detected, and renal artery embolization was performed.After surgery on (b)(6) 2016, the patient retained the foley catheter, showing gross hematuria.The patient was diagnosed with acute myocardial infarction and acute left heart failure on (b)(6) 2016, treated with medication.Later acute pancreatitis was diagnosed without a clear onset date, then patient was treated with medication.The patient was discharged and transferred to a lower level hospital on (b)(6) 2016.A review of documentation including the complaint history, device history record (dhr), drawing, instructions for use (ifu) and quality control was conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.However, a document-based investigation evaluation was performed.A review of the device master record (dmr) concluded that sufficient inspection activities are in place to identify potential non-conformances prior to distribution.A review of the design history files found that the affected product is both safe and effective for its intended use.A review of the dhrs for the reported complaint device lot (7134510) and related component/supplier sub-assembly lots revealed no recorded non-conformances.A database search found this to be the only event associated with the complaint device lot.Additionally, this device is a one-device lot.Because there are no related non-conformances, adequate inspection activities have been established, there is objective evidence that the dhr was fully executed, and no other lot related complaints that have been received from the field, it was concluded that there is no evidence that nonconforming product exists in house or in field.Cook has also concluded that there is objective evidence that the device was manufactured to specification.Cook also reviewed product labeling.The product instructions for use (ifu) states the following in consideration of the reported failure mode: "4.2 patient selection, treatment and follow-up key anatomical elements that may affect successful exclusion of the aneurysm include severe proximal neck angulation (>60 degrees for infrarenal neck to axis of aaa or >45 degrees for suprarenal neck relative to the immediate infrarenal neck); short proximal aortic neck (<15 mm); an inverted funnel shape (greater than 10% increase in diameter over 15 mm of proximal aortic neck length;) and circumferential thrombus and/or calcification at the arterial implantation sites, specifically the proximal aortic neck and distal iliac artery interface.In the presence of anatomical limitations, a longer neck may be required to obtain adequate sealing and fixation.Irregular calcification and/or plaque may compromise the attachment and sealing at the fixation sites.Necks exhibiting these key anatomical elements may be more conducive to graft migration or endoleak.Vessels that are significantly calcified, occlusive, tortuous or thrombus-line may preclude placement of the endovascular graft and/or may increase the risk of embolization.4.4 device selection strict adherence to the zenith flex aaa endovascular graft ifu sizing guide is strongly recommended when selecting the appropriate device size (tables 10.5.1 and 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.4.5 implant procedure: inaccurate placement and/or incomplete sealing of the zenith flex aaa endovascular graft within the vessel may result in increased risk of endoleak, migration or inadvertent occlusion of the renal or internal iliac arteries.5.2 potential adverse events: endoleak.11 directions for use anatomical requirements iliofemoral access vessel size and morphology (minimal thrombus, calcium and/or tortuosity should be compatible with vascular access techniques and accessories.Final angiogram: position angiographic catheter just above the level of the renal arteries.Perform angiography to verify that the renal arteries are patent and that there are no endoleaks.Verify patency of internal iliac arteries.Confirm there are no endoleaks or kinks and verify position of proximal gold radiopaque markers.Remove the sheaths, wires and catheters.Note: if endoleaks or other problems are observed, refer to the suggested instructions for use for the zenith aaa endovascular graft ancillary components.Repair vessels and close in standard surgical fashion.12.4 ultrasound: ultrasound imaging may be performed in place of contrast ct when patient factors preclude the use of image contrast media.Ultrasound may be paired with non-contrast ct.A complete aortic duplex is to be videotaped for maximum aneurysm diameter, endoleaks, stent patency and stenosis.12.6 additional surveillance and treatment: additional surveillance and possible treatment is recommended for: aneurysms with type i endoleak; aneurysms with type iii endoleak; aneurysms enlargement, >/- 5mm of maximum diameter (regardless of endoleak status) migration; inadequate seal length." based on the information provided, no product or imaging returned, and the results of the investigation, a definitive root cause could not be established.However, endoleaks are a known inherent risk of using this device.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• Brand Name: ZENITH FLEX 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: 9163603
• Report Number: 1820334-2019-02546
• Device Sequence Number: 16682283
• Product Code: MIH
• UDI-Device Identifier: 10827002484518
• UDI-Public: (01)10827002484518(17)180728(10)7134510
• 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: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2020

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/28/2018
• Device Model Number: N/A
• Device Catalogue Number: TFLE-12-90-ZT
• Device Lot Number: 7134510
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/25/2019
• Supplement Date Received by Manufacturer: 03/25/2020
• Initial Report FDA Received Date: 10/07/2019
• Supplement Report FDA Received Date: 03/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 72 YR