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

Model Number	HG-18-90-32
Medical Device Problem Codes	Difficult to Insert (1316); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/20/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem 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.
Additional 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.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: ENDO ANCHOR SYSTEM- HELI-FX TAA
• Common Device Name: ENDOVASCULAR SUTURING SYSTEM
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 7435520
• Report Number: 2953200-2018-00550
• Device Sequence Number: 1006902
• Product Code: OTD
• UDI-Device Identifier: 00763000025281
• UDI-Public: 00763000025281
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K140036
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: 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
• Initial Date Received by Manufacturer: 03/20/2018
• Supplement Date Received by Manufacturer: 07/13/2018; 08/08/2018; 10/08/2018
• Initial Report FDA Received Date: 04/17/2018
• Supplement Report FDA Received Date: 07/24/2018; 10/03/2018; 10/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1