MAUDE Adverse Event Report: COOK INC ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY; MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Model Number	N/A
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/23/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant products: coda-2-10.0-35-120-32.Occupation: unknown.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 an endoleak was discovered by angiography after the placement of a zenith flex aaa endovascular graft bifurcated main body.Anticoagulation medication was administered to the patient during the procedure, though the dosage is unknown.A coda-2-10.0-35-120-32 balloon was "used to expand the proximal of main stent, the conjunction of iliac branch and distal of iliac branch" and was inflated with a 20ml syringe.Unfortunately, the endoleak was still present.An angiography wire guide was placed in the stent and membrane infiltration was suspected.In the end, the endoleak was not resolved.The patient did not require any additional procedures.The stent remains in the patient.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Investigation - evaluation.A review of the complaint history, device history record (dhr), drawing, instructions for use (ifu), quality control, and specifications, as well as a review of medical imaging of the device was conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.However, pre-implantation angiogram and completion angiogram videos were provided and sent for expert image review.It was found that the endoleak was likely created by stretching or tearing a suture hole, likely classifying it as a type 3b endoleak.The endoleak was observed through the stent fabric on the right side of the graft between the fourth and fifth main body stents.The main body graft was likely angioplastied based on how the graft was positioned.Overall, there is no evidence to suggest that the device was not manufactured to specifications.Additionally, a document-based investigation evaluation was performed.Cook has concluded that sufficient controls and inspections are in place to prevent the release of non-conforming product related to the reported failure mode.A review of the design history file found that the affected product is safe and effective for its intended use.The dhr for the complaint lot (8617112) and related subassembly lots found no related non-conformances.A database search found this to be the only event associated with the provided complaint lot.Additionally, the complaint device is a one-device-lot.Because there are adequate inspection activities in place, objective evidence that the dhr was fully executed, no related non-conformances, and no other lot-related complaints received from the field, cook has concluded that there is no evidence that non-conforming product exists in house or in field.Cook also reviewed product labeling.The product instructions for use, [t_zaaaf_rev4] ¿zenith flex® aaa endovascular graft with the z-trak¿ introduction system¿, 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 an enlarging aneurysm, 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.4.5 implant procedure ¿ do not bend or kink the delivery system.Doing so may cause damage to the delivery system and the zenith flex aaa endovascular graft.4.6 molding balloon use ¿ use care in inflating the balloon within the graft in the presence of calcification, as excessive inflation may cause damage to the vessel.5 adverse events 5.2 potential adverse events adverse events that may occur and/or require intervention include, but are not limited to: ¿ endoleak ¿ endoprosthesis: puncture 11 directions for use 11.1 bifurcated system 11.1.12 molding balloon insertion 5.Expand the molding balloon with diluted contrast media (as directed by the manufacturer) in the area of the most proximal covered stent and the infrarenal neck, starting proximally and working in the distal direction.6.Withdraw the molding balloon to the ipsilateral limb overlap and expand.7.Withdraw the molding balloon to the ipsilateral distal fixation site and expand.8.Deflate and remove molding balloon.Transfer the molding balloon onto the contralateral wire guide and into the contralateral iliac leg introduction system.Advance molding balloon to the contralateral limb overlap and expand.9.Withdraw the molding balloon to the contralateral iliac leg/vessel distal fixation and expand.12 imaging guidelines and postoperative follow-up 12.1 general ¿ the long-term performance of endovascular grafts has not yet been established.All patients should be advised that endovascular treatment requires lifelong, regular follow-up to assess their health and 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.Patients should be counseled on the importance of adhering to the follow-up schedule, both during the first year and at yearly intervals thereafter.Patients should be told that regular and consistent follow-up is a critical part of ensuring the ongoing safety and effectiveness of endovascular treatment of aaas.12.6 additional surveillance and treatment additional surveillance and possible treatment is recommended for: ¿ aneurysms with type iii endoleak" based on the information provided, no product returned, and the results of our investigation, a root cause was traced to unintended use error by the user.Additionally, endoleaks are a known inherent risk of the device.It is possible that the endoleak was caused by inflation of the molding balloon inside the main body stents, causing one of the stents to puncture the graft, though this cannot be confirmed at this time.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 patient and/or event info has been received since the previous medwatch report was sent.

• Brand Name: ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY
• Common Device Name: MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 9310104
• Report Number: 1820334-2019-02837
• Device Sequence Number: 11390404
• Product Code: MIH
• UDI-Device Identifier: 10827002484242
• UDI-Public: (01)10827002484242(17)200305(10)8617112
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• PMA/510(K) Number: P020018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/31/2020

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: 03/05/2020
• Device Model Number: N/A
• Device Catalogue Number: TFFB-30-111-ZT
• Device Lot Number: 8617112
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/24/2019
• Supplement Date Received by Manufacturer: 01/29/2020
• Initial Report FDA Received Date: 11/12/2019
• Supplement Report FDA Received Date: 01/31/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 78 YR