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	G32183
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/27/2015
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 while the zenith aaa endovascular graft aaa ancillary component main body extension was being deployed, the device was pressed against the right side of the aortic wall and only deployed properly on the left side.The physician could not determine if the device had been positioned correctly below the lowest renal artery, so they decided to remove the graft, which was re-sheathed and removed successfully.Another backup device was prepared, but the physician decided to make a second attempt at deploying the original graft.With some difficulty, the new graft was deployed into the existing zenith graft, but it was approximately 4-5 mm lower than intended.The physician continued and implanted a limb extension.A final digital subtraction angiogram was performed, showing a successful result with no type i endoleaks.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: 7597271
• Report Number: 1820334-2018-01773
• Device Sequence Number: 11029071
• Product Code: MIH
• UDI-Device Identifier: 10827002321837
• UDI-Public: (01)10827002321837(17)151001(10)4543965
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• 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?: Yes
• Operator of Device: Health Professional
• Device Model Number: G32183
• Device Catalogue Number: ESBE-30-39
• 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: 06/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1