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

Model Number SA-85

Device Problems Break (1069); Device Difficult to Setup or Prepare (1487); Device Dislodged or Dislocated (2923)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 11/20/2017

Event Type  Injury  

Manufacturer Narrative

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

Event Description

A heli-fx was used as an accessory device along with an endurant stent graft system for the endovascular treatment of a 70mm abdominal aortic aneurysm.It was reported that after placing the endurant stent graft with two limbs the physician attempted to place endoanchors to anchor the stent graft to the aortic neck.After the 5th endoanchor placement a successful stage 1 deployment was made and the endoanchor engaged to the aortic wall which was confirmed via flouro.However, it was reported that, during stage 2 of deploying the endoanchor appeared to jump.When the applier was removed another endoanchor was attempted to be loaded onto the applier but was unable to load.After further investigation it was noted that the back half of the endoanchor appeared to be stuck inside the applier preventing any further endoanchors from being loaded.It was reported that the remaining half of the endoanchor was removed using a pair of hemostats.Once the fractured part of the endoanchor was removed a new endoanchor was successfully loaded into the applier and the procedure was completed.It was reported that the other half of the fractured endoanchor appears to be in the aortic wall but not engaging the stent graft.The physician has reported that the cause of the event was due to the endoanchor hitting the stent strut on the stent graft causing the endoanchor to fracture.No clinical sequelae were reported and the patient is fine.

Manufacturer Narrative

Films review summary: the cause of the endoanchor fracture could not be determined from the pre-implant films provided.The proximal neck was conical-shaped, minimally calcified, essentially straight, with areas of thrombus.Images during implant and post-implant were not available, and the device <(><<)>(><(>&<)><(><<)>)> fractured anchor were also not available for return.It is possible that the report of the anchor contacting the stent graft strut during implant may have caused the anchor to fracture.It is also possible that implanting into the areas of calcification and thrombus may have caused the fracture.Improper apposition, excessive catheter torque build-up, engaging multiple fabric layers, and excessive unsupported applier are also potential contributors to an endoanchor fracture.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Additional information: device expiration date.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ENDO ANCHOR SYSTEM - HELI-FX AAA
• 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, CA ; 7075917650
• MDR Report Key: 7103622
• MDR Text Key: 94347438
• Report Number: 2953200-2017-01952
• Device Sequence Number: 1
• Product Code: OTD
• Combination Product (y/n): N
• Reporter Country Code: US
• 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,Followup
• Report Date: 05/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/07/2019
• Device Model Number: SA-85
• Device Catalogue Number: SA-85
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/27/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/11/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/07/2017
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR