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

Device Problems Material Frayed (1262); Failure to Advance (2524)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/08/2016

Event Type  malfunction  

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 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
• Type of Device: MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8128294891
• MDR Report Key: 7593639
• MDR Text Key: 111301278
• Report Number: 1820334-2018-01784
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 10827002321820
• UDI-Public: (01)10827002321820(17)160930(10)5299704
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: G32182
• Device Catalogue Number: ESBE-28-39
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/06/2018
• Initial Date FDA Received: 06/12/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/30/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Weight: 55