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

Model Number HG-18-90-32

Device Problems Difficult to Insert (1316); Material Deformation (2976)

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: the guide and dilator were returned for analysis.A slight bump was observed proximal to the tip.Excessive damage was observed to the guide tip with braid wire protruding through the catheter material.Delamination and exposed braid wire are visible within the tip of the guide.Material detachment is observed at the guide tip.The radiopaque marker was not located at the guide tip.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

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

Manufacturer Narrative

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: 7435520
• MDR Text Key: 105674677
• Report Number: 2953200-2018-00550
• Device Sequence Number: 1
• Product Code: OTD
• UDI-Device Identifier: 00763000025281
• UDI-Public: 00763000025281
• 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,Followup,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: 11/07/2019
• Device Model Number: HG-18-90-32
• Device Catalogue Number: HG-18-90-32
• Device Lot Number: 0008869879
• 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: 10/08/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/07/2017
• 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