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	G32182
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/08/2016
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 physician intended to place a zenith aaa endovascular graft aaa ancillary component main body extension to prevent further enlargement of the aneurysm.The device was advanced from the right femoral artery, but it became caught on the distal side of the previously placed leg graft and would not advance.The wire was then replaced with a stiffer one, but the delivery system still would not advance, so it was removed from the patient.The user then found that the tip of the delivery sheath was frayed.The tip was manually amended and reinserted from the left side, but it still failed to advance.This part of the procedure was abandoned, but the rest of the procedure was completed with a coil embolization of the left internal iliac artery and placement of another stent graft in the external iliac artery.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: 7593639
• Report Number: 1820334-2018-01784
• Device Sequence Number: 13988761
• Product Code: MIH
• UDI-Device Identifier: 10827002321820
• UDI-Public: (01)10827002321820(17)160930(10)5299704
• 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): 06/12/2018

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: G32182
• Device Catalogue Number: ESBE-28-39
• 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: 06/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 55