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

Model Number HA-18-114

Device Problems Break (1069); Device Difficult to Setup or Prepare (1487)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/22/2017

Event Type  malfunction  

Event Description

A heli-fx applier and endoanchors were selected as an accessory device for the endovascular treatment of the patient for a thoracic aortic aneurysm.It was reported that the endoanchors were planned for implantation in the distal neck of another manufacturers thoracic stent graft in a complex anatomy.The physician reported that one of the endoanchors was partially deployed and a part remained broken inside the applier.It was not possible to load any other endoanchors and so the applier was replaced with a new heli-fx applier.This resolved the event.As per the physician the cause of the event was due to the challenging anatomy of the patient.No additional clinical sequelae were reported and the patient is fine.

Manufacturer Narrative

Device evaluation summary: there was no damage observed to the device or the tip.There were one (1) portholes opened on the endoanchor cassette.Visual inspection confirmed there was no endoanchor loaded in the applier.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 7.80v.A new battery was attached, and the unit powered up with the blue error light on, the forward light flashing and the back light on.The device was restarted in factory mode with the blue error light on, forward light flashing, back light on.An endoanchor was loaded and deployed with no abnormalities 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 CARDIOVASCULAR SANTA ROSA; 3576 unocal place; santa rosa CA 95403
• Manufacturer (Section G): MEDTRONIC CARDIOVASCULAR SANTA ROSA; 3576 unocal place; santa rosa CA 95403
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway, CA ; 7075917650
• MDR Report Key: 7107402
• MDR Text Key: 94672034
• Report Number: 2953200-2017-01959
• Device Sequence Number: 1
• Product Code: OTD
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 10/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2019
• Device Model Number: HA-18-114
• Device Catalogue Number: HA-18-114
• Device Lot Number: 50146043
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/11/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/02/2017
• 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