MAUDE Adverse Event Report: COOK INC ZENITH FLEX WITH Z-TRAK AAA ENDOVASCULAR GRAFT MAIN BODY EXTENSION; MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Model Number	G55210
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/23/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter customer (person), postal code, phone: (b)(6).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 type 1a endoleak developed following implantation of a zenith flex with z-trak aaa endovascular graft main body extension.On (b)(6) 2013, the patient initially had a main body graft and two iliac leg grafts implanted.During the procedure, the main body graft landed lower than expected, prompting implantation of a main body extension graft.Follow-up ct imaging revealed the aneurysm sac was continuing to grow.This was thought to be a consequence of either a type 1b and/or type 2 endoleak.As a result, a competitor limb graft was used to extend into the left external iliac artery and the inferior mesenteric artery was coiled.Following the secondary intervention, the aneurysm sac continued to grow, which was thought to be the consequence of a type 1a endoleak (as a result of "dilated neck causing graft migration") and/or a type 1b endoleak (as a result of "dilated right common iliac artery").As a result, on (b)(6) 2020, a zenith flex with z-trak aaa endovascular graft main body extension (subject of this report) along with a leg graft and a right iliac bifurcation branched device were implanted.Following implantation of these devices, final imaging run revealed no evidence of any endoleaks.The patient was reported to be doing well at that time, and the aneurysm sac was stated to be smaller in size following.Ct imaging performed on (b)(6) 2021 revealed a type 1a endoleak on the zenith flex with z-trak aaa endovascular graft main body extension as well as disease progression above the proximal seal zone.Though one has not currently been performed, an intervention including placement of a proximal extension graft may be planned.No adverse effects have been reported for this event.Additional information regarding the patient and event, as well as clarification regarding the timeline of events, has been requested but is currently unavailable.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
Additional Manufacturer Narrative
Investigation - evaluation on (b)(6) 2021, cook became aware of an incident where a type 1a endoleak was noted within a zenith flex with z-trak aaa endovascular graft main body extension (rpn: esbe-36-50-zt, lot: 9913114).The issue was reported by a physician at townsville university hospital l in australia., who plans to perform repair of the expanding aaa sac.A review of documentation including the complaint history, device history record (dhr), drawing, instructions for use (ifu), manufacturing instructions (mi), quality control, and specifications of the device was conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.However, a single post-op ct study dated (b)(6) 2021 was provided (reported to be approximately 8 years post-op) was provided and submitted for expert image review.The main body graft begins 8 mm below the right renal artery with no circumferential graft wall apposition due to an aortic diameter of 44x33 mm.The proximal cuffs, including the subject device, are positioned directly below the right renal artery.The aortic diameter begins to dilate at this point, measuring 43x32 mm, and there is no proximal seal.A focal type 1a endoleak is seen around the proximal cuffs.It is unclear if the endoleak extends into the remainder of the infrarenal sac.Comparing the contrast and non-contrast series, there does not appear to be an active contrast leak into the main sac beyond the proximal cuff.Cook has concluded that the device was manufactured to specification.Additionally, 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 this failure mode prior to distribution.A review of the design history file (dhf) showed that this device is both safe and effective for its intended use.A review of the dhrs for the reported complaint device lot (9913114) and the related graft subassembly lot revealed no recorded non-conformances.A database search did not identify any other events associated with the reported device lot.It should be noted that esbe devices are distributed via one-device lots.As there are adequate inspection activities in place, there is objective evidence that the dhr was fully executed, there are no related non-conformances, and no other lot-related complaints have been received from the field, cook has concluded that there is no evidence suggesting non-conforming product exists either in house or in the field.Cook also reviewed product labeling.The product ifu, t_eaaa36_rev3 ¿zenith aaa ancillary components,¿ provides the following information to the user 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 ¿ size of the pre-existing zenith aaa endovascular graft should be assessed before selecting a main body extension.4.5 implant procedure ¿ inaccurate placement and/or incomplete sealing of the zenith spiral-z aaa ancillary components 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 ¿ endoprosthesis: improper component placement; incomplete component deployment; component migration; component separation from another graft component; suture break; occlusion; infection; stent fracture; graft material wear; dilation; erosion; puncture; perigraft flow; and corrosion 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.12.3 additional surveillance and treatment additional surveillance and possible treatment is recommended for: ¿ aneurysm enlargement, = 5 mm of maximum diameter (regardless of endoleak status)¿ based on the information provided, examination of returned imaging, and the results of our investigation, a definitive root cause for this event was unable to be established.However, it should be noted that 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.

• Brand Name: ZENITH FLEX WITH Z-TRAK AAA ENDOVASCULAR GRAFT MAIN BODY EXTENSION
• Common Device Name: MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 12088594
• Report Number: 1820334-2021-01644
• Device Sequence Number: 3870831
• Product Code: MIH
• UDI-Device Identifier: 10827002552101
• UDI-Public: (01)10827002552101(17)220808(10)9913114
• Combination Product (Y/N): N
• PMA/510(K) Number: P020018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/27/2021

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/08/2022
• Device Model Number: G55210
• Device Catalogue Number: ESBE-36-50-ZT
• Device Lot Number: 9913114
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/07/2021
• Supplement Date Received by Manufacturer: 08/09/2021
• Initial Report FDA Received Date: 06/29/2021
• Supplement Report FDA Received Date: 08/27/2021
• 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: COOK ZBIS-12-45-41, LOT A1048415; COOK ZISL-16-59, LOT 9235561
• Patient Age: 74 YR