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

Model Number SA-85

Device Problem Difficult to Insert (1316)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/28/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

A heli-fx guide, applier and endoanchors were used prophylactically in the endovascular treatment of the patient for an infrarenal abdominal aortic aneurysm.It was reported that the heli-fx guide and applier initially passed easily via the right femoral sheath into the proximal portion of the stent graft.3 endoanchors were placed in the ap position.It was noted that there was some difficulty in passing the heli-fx applier through the guide for placement of the third endoanchor.A fourth endoanchor was placed in the oblique position and again some difficulty was noted on passing the heli-fx applier.Another endoanchor on the left was attempted but the applier couldn't be passed through the guides distal portion.The endoanchor and sheath were removed and replaced with a stiff wired and contrast imaging showed good apposition proximally with no endoleak.It was noticed on contrast imaging that the metal ring of the end of the heli-fx guide had come free in the femoral artery.An angled guidewire was passed through the right femoral sheath, through the ring and a 12mm balloon was used to remove it.It was reported that the cause of the event is unknown.It is reported that the patient tolerated the procedure well, despite the extra time required for the procedure, which was mostly related to the aortic tortuosity and difficulty placing endograft and aptus endoanchors.No additional clinical sequelae were reported and the patient is fine.

• 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 ; 091708096
• MDR Report Key: 7380674
• MDR Text Key: 104033420
• Report Number: 2953200-2018-00459
• Device Sequence Number: 1
• Product Code: OTD
• UDI-Device Identifier: 00763000006617
• UDI-Public: 00763000006617
• 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,health
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/13/2019
• Device Model Number: SA-85
• Device Catalogue Number: SA-85
• Device Lot Number: 0008794016
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/06/2018
• Date Device Manufactured: 09/13/2017
• 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 Age: 70 YR
• Patient Weight: 75