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

Model Number	HG-16-62-28
Medical Device Problem Codes	Detachment Of Device Component (1104); Difficult to Insert (1316)
Health Effect - Clinical Code	Injury (2348)
Date of Event	02/28/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem 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
• Common Device Name: ENDOVASCULAR SUTURING SYSTEM
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 7380675
• Report Number: 2953200-2018-00460
• Device Sequence Number: 11094190
• Product Code: OTD
• UDI-Device Identifier: 00643169647626
• UDI-Public: 00643169647626
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K140036
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 03/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2018
• Device Model Number: HG-16-62-28
• Device Catalogue Number: HG-16-62-28
• Device Lot Number: 49975066
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2018
• Initial Report FDA Received Date: 03/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR
• Patient Weight: 75