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	G55244
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Reporter: customer (person): phone: (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 that a (b)(6) year-old male patient developed a type 1b endoleak following implantation of a zenith flex with spiral-z technology aaa endovascular graft iliac leg.Consequently, a zenith alpha spiral-z endovascular leg (zisl-13-93) was implanted in a secondary procedure to extend through to the external iliac artery.The need for an extension device was observed through routine follow-up scans.The patient initially had a fenestrated graft with a limb (the subject of this report) implanted in 2016.The patient's common iliac artery expanded following the procedure.During the secondary procedure, another event occurred involving a cook embolization coil which is reported under mdr reference #1820334-2020-00897.Additional information regarding the patient and imaging has been requested but is currently unavailable.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.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
In additional information received on 12may2020, it was reported that the patient's secondary procedure was successful.He was discharged the following day.No imaging is available from the customer.
Additional Manufacturer Narrative
Investigation ¿ evaluation: the complaint facility (b)(6) hospital informed cook on 20apr2020 of an incident involving a zenith flex with spiral-z technology aaa endovascular graft iliac leg (zsle-24-39-zt) from lot 5997975.A type 1b endoleak was reported.A leg extension was implanted to resolve the leak.The patient reportedly experienced no adverse effects as a result of this incident, no additional harm was reported.A review of the complaint history, device history record, drawing, instructions for use (ifu), and quality control, as well as an interview of personnel were conducted during the investigation.The complaint device was not returned to cook for evaluation and no imaging was provided.Additionally, a document based investigation evaluation was performed.A review of the device master record found that proper procedures are in place to identify and prevent this failure mode prior to device distribution.A review of the design history file found that the affected product is safe and effective for its intended use.A review of the device history record found no nonconformances or additional complaints associated with this device lot.There is no evidence to suggest there is any nonconforming product in house or out in the field.It was concluded the complaint lot was manufactured to current specifications.Additionally, a review of the product labeling for the device was completed.The instructions for use state the following instructions related to the reported failure mode: 4 warnings and precautions.4.1 general.Additional endovascular interventions or conversion to standard open surgical repair following initial endovascular repair should be considered for patients experiencing enlarging aneurysms, unacceptable decrease in fixation length (vessel and component overlap) and/or endoleak.An increase in aneurysm size and/or persistent endoleak or migration may lead to aneurysm rupture.4.2 patient selection, treatment and follow-up.Zenith spiral-z iliac artery distal fixation site greater than 10 mm in length and 7.5-20 mm in diameter (measured outer wall to outer wall) is required.These sizing measurements are critical to the performance of the endovascular repair.4.3 pre-procedure measurement techniques and imaging.Diameters utilizing ct, diameter measurements should be determined from the outer wall to outer wall vessel diameter (not lumen measurement) to help with proper device sizing and device selection.4.4 device selection.Strict adherence to the zenith spiral-z aaa iliac leg ifu sizing guide is strongly recommended when selecting the appropriate device size (table 10.5.1).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 spiral-z aaa iliac leg within the vessel may result in increased risk of endoleak, migration or inadvertent occlusion of the internal iliac arteries.5.2 potential adverse events.Adverse events that may occur and/or require intervention include, but are not limited to: endoleak.12.1 general.All patients should be advised that endovascular treatment requires lifelong, regular follow-up to assess their health and the performance of their endovascular graft.Patients with specific clinical findings (e.G., endoleaks, enlarging aneurysms or changes in the structure or position of the endovascular graft) should receive additional follow-up.12.2 additional surveillance and treatment.Additional surveillance and possible treatment is recommended for: aneurysms with type i endoleak.Based on the information provided, no inspection of the product, and the results of the investigation, it was determined the endoleak seen is a known inherent risk of zenith devices.The appropriate personnel have been notified.Per the quality engineering risk assessment, no further action is required.Cook 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.
Event or Problem Description
No additional patient/event information has been received since the previous medwatch report was sent.

• 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: 10029396
• Report Number: 1820334-2020-00916
• Device Sequence Number: 14165134
• Product Code: MIH
• UDI-Device Identifier: 10827002552446
• UDI-Public: (01)10827002552446(17)180708(10)5997975
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: P020018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/31/2020

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: 07/08/2018
• Device Model Number: G55244
• Device Catalogue Number: ZSLE-24-39-ZT
• Device Lot Number: 5997975
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/20/2020
• Supplement Date Received by Manufacturer: 05/12/2020; 08/03/2020
• Initial Report FDA Received Date: 05/06/2020
• Supplement Report FDA Received Date: 05/15/2020; 08/31/2020
• 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: UNKNOWN FENESTRATED GRAFT.
• Outcome Attributed to Adverse Event: Required Intervention