ENDO ANCHOR SYSTEM - HELI-FX AAA SA-85

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-02-25 for ENDO ANCHOR SYSTEM - HELI-FX AAA SA-85 manufactured by Medtronic Ireland.

Event Text Entries

[188749499] Product analysis summary: the reported endoanchor fracture could not be confirmed (or ruled out) from the limited images received and the cause of the event could not be determined. Due to the low resolution and single lateral view of the angiograms received, the reported event is difficult to assess. Lack of a video angiograms showing the deployment of the endoanchors and reported removal of the fractured fragment within the heli-fx applier were not seen in the returned films. The patient? S pre-implant anatomy was not provided in order to allow for assessment of calcification or thrombus in the implantation area, and ct? S were not available for a comprehensive in-vivo assessment of the previously implanted non-mdt stent graft. Analysis of the returned films did not reveal any anatomical or visible device anomalies that could explain the reported event. It is possible that the interaction of the endoanchor with the non-mdt stent ring strut may have been a contributor to the reported fracture event. Other possible anatomical causes of the anchor fracture include implanting into areas of calcification, thrombus, and highly angulated anatomy. In addition, improper apposition, excessive catheter torque build-up, engaging multiple fabric layers, and excessive unsupported applier may have also contributed to the anchor fracture. A device issue cannot be ruled out as a potential cause. The delivery system and fractured anchor are pending return for analysis and the results will be summarized in a separate report. Additional information: it was confirmed that the broken part of the endoanchor remained fixed in the aortic wall. The heli-fx applier was used in an endoleak repair procedure on a non-mdt stent graft. It was confirmed that it was the third endoanchor that broke. As per the physician, the endoanchor was sheared by the struts of the non-mdt stent graft to a very poor position, so that the endoanchor was not 100% orthogonal to the aortic wall and the struts of the stent graft finally caught the endoanchor. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10

MAUDE Entry Details

• Report Number: 9612164-2020-00861
• MDR Report Key: 9749789
• Report Source: COMPANY REPRESENTATIVE,FOREIG
• Date Received: 2020-02-25
• Date of Report: 2020-03-23
• Date of Event: 2020-02-18
• Date Mfgr Received: 2020-02-25
• Device Manufacturer Date: 2019-09-24
• Date Added to Maude: 2020-02-25
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: ALISON SWEENEY
• Manufacturer Street: PARKMORE BUSINESS PARK WEST
• Manufacturer City: GALWAY
• Manufacturer Phone: 091708096
• Manufacturer G1: MEDTRONIC IRELAND
• Manufacturer Street: PARKMORE BUSINESS PARK WEST
• Manufacturer City: GALWAY
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: ENDO ANCHOR SYSTEM - HELI-FX AAA
• Generic Name: ENDOVASCULAR SUTURING SYSTEM
• Product Code: OTD
• Date Received: 2020-02-25
• Returned To Mfg: 2020-02-26
• Model Number: SA-85
• Catalog Number: SA-85
• Lot Number: 0009937212
• Operator: HEALTH PROFESSIONAL
• Device Availability: R
• Device Age: DA
• Device Eval'ed by Mfgr: Y
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: MEDTRONIC IRELAND
• Manufacturer Address: PARKMORE BUSINESS PARK WEST GALWAY

Patients

Patient Number	Treatment	Outcome	Date
1	0		2020-02-25