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	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/21/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.
Event or Problem Description
Information was provided that a (b)(6) male patient with a history of a left iliac artery aneurysm underwent an endovascular aneurysm repair (evar) procedure.After placing the main body, the user removed the gray positioner from the outer sheath and a large amount of blood leaked from the hemostatic valve.The physician turned the captor rotator to close, but blood still leaked.Therefore, the physician had to replace the sheath with another manufacturer's sheath.Two iliac leg grafts were implanted after replacing the sheath and the procedure was completed without further problems.The patient did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
Investigation - evaluation: a review of actual device, documentation, complaint history, drawings, device history record, trending, specification and quality control data was conducted during the investigation.The complaint device was returned for evaluation and the following was found: the iris valve was detached and two tears were observed in the webbing on the bottom disk.The drawing for the hemostatic valve #40470 was examined and it can be confirmed that the iris valve is a tube in the hemostatic valve that stops blood flow when turned.Three stack disks make up the captor flow valve and these are the disks that were torn.The device history record was reviewed, for the finished assembly, captor flexor sheath assembly, captor valve assembly and the silicone disc-10558, and one non-conformances on captor value assembly was noted.A review of the non-conformance data revealed that the non-conformance listed on the device history record was for an alignment error.A complaint history search was performed and it was found that this complaint is the only one associated to the complaint lot number 5692810.The root cause is most likely a manufacturing error.The iris valve may have failed due to the physician turning the lock too many times.The physician may have tried to use the lock multiple times because the webbing in the disks teared due to insufficient silicone oil, training procedure for applying silicone fluid to silicone discs was released 21april2015 (after the complaint device was manufactured) to prevent this issue from reoccurring.This document provides training in the application of silicone oil on the silicone discs.The appropriate personnel have been notified, we will continue to monitor for similar failure modes.Per the quality engineering risk assessment no further action is required.Measures have been previously initiated to address this issue.

• 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: 6036681
• Report Number: 1820334-2016-01115
• Device Sequence Number: 1514814
• Product Code: MIH
• UDI-Device Identifier: 10827002484174
• UDI-Public: (01)10827002484174(17)170311(10)5692810
• Combination Product (Y/N): N
• PMA/510(K) Number: P020018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/15/2017

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 Model Number: N/A
• Device Catalogue Number: TFFB-28-82-ZT
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 09/21/2016
• Supplement Date Received by Manufacturer: 07/31/2017
• Initial Report FDA Received Date: 10/18/2016
• Supplement Report FDA Received Date: 08/15/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 64 YR