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	G55238
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Codes	Thrombus (2101); No Code Available (3191)
Date of Event	04/08/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6).(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 on (b)(6) 2016, the patient was implanted with a zalb-30-118 (right side entry), zsle-16-74-zt (right side), zsle-20-74-zt (left side) to repair a 6.5cm abdominal aortic aneurysm (aaa).The doctor deliberately planned to land the graft 1cm below the renals in the more uniform segment.On (b)(6) 2019, the patient presented with an occluded right leg and thrombus extending into the right side of the main body.Additional information was provided on (b)(6) 2019.Surgical re-intervention was performed on saturday, (b)(6) 2019.Per the physician, it was a tough case.They lined the right side with self-expanding stents.Patient was only on aspirin for anti-coagulation therapy at the time of limb occlusion.The physician stated that they believed the main factor is tortuosity compounded by rapid sac shrinkage.There is a fair space between the fabric and the renal arteries.
Additional Manufacturer Narrative
D11 - concomitant medical products: lunderquist wires, coda balloon, glide wires, proglides.
Event or Problem Description
There is no new event information to report.
Event or Problem Description
No new event description information to report at this time.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unchanged or unavailable.Investigation - evaluation a review of documentation including the complaint history, device history record, instructions for use, quality control, specifications, as well as a visual inspection of the device was conducted during the investigation.The device is still implanted in the patient, therefore was not returned for evaluation.However, a postoperative ct study was provided for the investigation.The image reviewer confirmed right zsle thrombosis, zalb mural thrombus, and left zsle thrombus.The image reviewer stated that, ¿no anatomic explanation or risk factor could be confirmed.The right zsle step-off could induce thrombus formation from increased turbulence, although this is a common asymptomatic configuration.The presence of thrombus in the main body and the left zsle is unusual and suggests a pro-thrombotic tendency towards the endograft.¿ it should be noted that there was no mention of any stent migration in the imaging review.There is no past medical history available that could shed light on any patient predisposition to thrombus formation.Information regarding patient mobility, weight or inherited disorders that may have contributed to thrombus formation are also unavailable.There is no information regarding handling of the device.There is no information surrounding the procedure or any procedural difficulties.There are no planning and sizing sheets for review.Additionally, a document-based investigation evaluation was performed.It was concluded that there are sufficient inspection activities in place to identify this failure mode prior to device distribution.Design verification and validation testing showed that the affected product is safe and effective for its intended use.A review of the device history record found no nonconformance's in lot 6305907 that could have contributed to the failure mode.It should be noted that there were no other complaints reported for this lot number.There is no evidence to suggest that nonconforming product exists in house, in the field or that the device was manufactured out of specification.The instructions for use (ifu), provides the following information to the user related to the reported indications for use: "the zenith spiral-z aaa iliac leg with the z-trak introduction system is indicated for use with the zenith aaa endovascular graft family of products, including the zenith flex aaa endovascular graft, zenith alpha abdominal endovascular graft, zenith low profile aaa endovascular graft, zenith renu ancillary graft, zenith fenestrated aaa endovascular graft, zenith universal distal body endovascular graft, zenith flex aui, or zenith branch iliac endovascular graft, during either a primary or a secondary procedure in patients who have adequate iliac/femoral access compatible with the required introduction systems.The graft is used in combination with these products for the endovascular treatment of abdominal aortic and aorto-iliac aneurysms." warnings and precautions: ¿pre-existing regions of stenosis/narrowing (less than approximately 20mm id in the aorta or 7 to 8 mm id in the iliacs) have been shown to increase the risk of a thromboembolic event.¿ ¿patients with poor outflow or a hypercoagulable state (e.G., cancer) may be at an increased risk of thromboembolic event.¿ ¿vessels that are significantly calcified, occlusive, tortuous or thrombus-lined may preclude placement of the endovascular graft and/or may increase the risk of embolization.¿ ¿all patients should be advised that endovascular treatment requires life-long, regular follow-up to assess their health and the performance of the endovascular graft.¿ ¿strict adherence to the zenith spiral-z aaa iliac leg ifu sizing guide is strongly recommended when selecting the appropriate device size.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.¿ ¿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 renal or internal iliac arteries.¿ potential adverse events: ¿arterial or venous thrombosis and/or pseudoaneurysm.¿ ¿graft or native vessel occlusion.¿ instructions for use: 11.1.6.4.¿introduce the ipsilateral iliac leg delivery system and continue advancing slowly until the proximal edge of the ipsilateral leg graft aligns with the proximal edge of the previously-placed contralateral leg graft.¿ there is also mention that the right zsle was 4mm and the left zsle was 9mm above the flow divider.The instructions for use state, ¿introduce the ipsilateral iliac leg delivery system, and continue advancing slowly until the proximal edge of the ipsilateral leg graft aligns with the proximal edge of the previously-placed contralateral leg graft.¿ it is not known if the 5mm difference in the right and left zsle devices was significant enough to cause or contribute thrombus formation.Based on the information provided, no returned product, and the results of our investigation, a definitive root cause could not be traced to the device, but rather to an adverse event related to the patient condition.It was concluded that human anatomy and disease progression contributed to this incident.The appropriate personnel have been notified and we will continue to monitor for similar complaints.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.

• 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: 8542119
• Report Number: 1820334-2019-00521
• Device Sequence Number: 18932639
• Product Code: MIH
• UDI-Device Identifier: 10827002552385
• UDI-Public: (01)10827002552385(17)181030(10)6305907
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/26/2019

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: 10/30/2018
• Device Model Number: G55238
• Device Catalogue Number: ZSLE-16-74-ZT
• Device Lot Number: 6305907
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/08/2019
• Supplement Date Received by Manufacturer: 04/08/2019; 05/31/2019
• Initial Report FDA Received Date: 04/23/2019
• Supplement Report FDA Received Date: 05/13/2019; 06/26/2019
• 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: 76 YR