MAUDE Adverse Event Report: MEDTRONIC IRELAND ENDO ANCHOR SYSTEM - HELI-FX TAA; ENDOVASCULAR SUTURING SYSTEM

Model Number HA-18-114

Device Problem Difficult to Insert (1316)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/20/2018

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

A heli-fx guide, and heli-fx applier and endoanchors were used prophylactically in the endovascular treatment of the patient for ano ther manufacturers stent graft.It was reported that during the index procedure after the implantation of the first two endoanchors the physician was not able to advance the heli-fx applier through the heli-fx guide when the guide was bent.As two endoanchors had been successfully implanted the procedure was completed without further intervention.As per the physician the cause of the event was due to obstruction of the tip of the guide by a part of the guide itself which was noted after removal of the guide from the patient.It was noted that the applier worked successfully.No additional clinical sequelae were reported and the patient is fine.

Manufacturer Narrative

Device evaluation summary: there was no damage observed to the device.An endoanchor was fully loaded in the housing.The handle was opened, and no fluid or blood was observed within the handle.No corrosion was observed to the circuit board or connector pins.All wires and connectors within the handle appeared to be intact and properly connected.The battery was removed and measured 8.79v.A new battery was attached, and the unit powered up with the blue error light flashing, the forward light unresponsive and the back light flashing.The endoanchor was deployed with no issues noted.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ENDO ANCHOR SYSTEM - HELI-FX TAA
• Type of Device: ENDOVASCULAR SUTURING SYSTEM
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; 091708096
• MDR Report Key: 7435517
• MDR Text Key: 105672717
• Report Number: 2953200-2018-00549
• Device Sequence Number: 1
• Product Code: OTD
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K140036
• 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,Followup
• Report Date: 10/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/18/2019
• Device Model Number: HA-18-114
• Device Catalogue Number: HA-18-114
• Device Lot Number: 0008926802
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/04/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/18/2017
• 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