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	G55239
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Codes	Aneurysm (1708); No Code Available (3191)
Date of Event	10/07/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Suspect medical device: the patient had 2 zenith flex with spiral-z technology aaa endovascular graft iliac legs implanted.Information regarding the other device identity is: gpn: (b)(4), rpn: zsle-16-74-zt, lot # :13217376.Concomitant medical products: zfen-p-2-30-124-r, lot # ac1062090; zfen-d-12-28-91-c, lot # ac1062091.(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 patient experienced a type iii endoleak after implantation of a zenith flex with spiral-z technology aaa endovascular graft iliac leg.The (b)(6) male patient underwent implantation of 2 zenith fenestrated grafts and 2 zenith flex with spiral-z technology aaa endovascular graft iliac legs on (b)(6) 2020.Please note the fenestrated grafts are not approved for sale in the us.Imaging performed at the end of the implantation procedure confirmed a leak, which at the time was thought to be a potential type ii endoleak.No decision was made to perform an intervention at that time, as the patient's condition was to be re-evaluated at a later date.At the 30 day ct follow up, a significant endoleak and filling of the aneurysm sac was still observed.Diagnostic angiograms a type iii endoleak, thought to be a tear or defect at the flow divider.The patient was scheduled for a procedure to reline the grafts on (b)(6) 2020, due to the risk of rupture.Information regarding the additional procedure is not currently available.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.Additional information: b7 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.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or 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 event details have been received since the previous medwatch report was sent.
Additional Manufacturer Narrative
Correction: upon completion of the investigation, this complaint was unable to be confirmed.Given the available information and imaging, it was determined that an endoleak did not form on this device/these devices.This complaint is no longer reportable.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or 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 details have 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: 10734481
• Report Number: 1820334-2020-01940
• Device Sequence Number: 16929130
• Product Code: MIH
• UDI-Device Identifier: 10827002552392
• UDI-Public: (01)10827002552392(17)230623(10)13240288
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• PMA/510(K) Number: P020018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/25/2021

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: 06/23/2023
• Device Model Number: G55239
• Device Catalogue Number: ZSLE-16-90-ZT
• Device Lot Number: 13240288
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/07/2020
• Supplement Date Received by Manufacturer: 10/26/2020; 02/08/2021
• Initial Report FDA Received Date: 10/26/2020
• Supplement Report FDA Received Date: 11/12/2020; 02/25/2021
• 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: BENTSON; CODA; KUMPE; LUNDERQUIST; MARKER PIG-ZF; MICRO-PUNCTURE; PERCLOSE; ZFEN-D-12-28-91-C; ZFEN-P-2-30-124-R
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR