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

Model Number	G42788
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/01/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This mdr is being filed after the associated complaint was reviewed under remediation protocol (b)(4), complaint/mdr retrospective review and remediation and reassessed as reportable.Additional complaint investigation and record remediation was not performed.
Event or Problem Description
It was reported that the zenith aaa endovascular graft aaa ancillary component main body extension was being used to repair the abdominal aortic aneurysm.The physician noticed that the tip was slightly frayed, but they did not think it would affect insertion into the vessel.However, the device would not advance into the common iliac artery.A backup device was used to complete the procedure, and there were no injuries or additional procedures reported.

• Brand Name: ZENITH AAA ENDOVASCULAR GRAFT AAA ANCILLARY COMPONENT 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: 7597413
• Report Number: 1820334-2018-01785
• Device Sequence Number: 1422623
• Product Code: MIH
• UDI-Device Identifier: 10827002427881
• UDI-Public: (01)10827002427881(17)170126(10)5597791
• Combination Product (Y/N): N
• 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
• Report Date (Section B): 06/13/2018

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?: No
• Operator of Device: Health Professional
• Device Model Number: G42788
• Device Catalogue Number: ESBE-32-58
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/06/2018
• Initial Report FDA Received Date: 06/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1