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

Model Number	SA-85
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	07/12/2019
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 applier was used as an accessory device for the endovascular treatment of an aortic aneurysm.It was reported that during the index procedure, the physician attempted to deploy an endoanchor as per the ifu, however the endoanchor did not adhere to the stent graft.It became loose and remained suspended in an existing stent graft.The physician then implanted an additional stent graft inside the existing stent graft, leaving the suspended endoanchor situated between the two stent grafts.The procedure was then completed.Per the physician the cause of the event was likely related to the patient's anatomy.No additional clinical sequelae were reported and the patient is fine.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that there was no significant calcification or tortuosity present in the patient¿s anatomy.The endoanchors were im planted in a valiant navion stent graft (b)(4).Two endoanchors were successfully implanted before the reported event occurred.

• 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: 8840454
• Report Number: 9612164-2019-03112
• Device Sequence Number: 11167136
• Product Code: OTD
• UDI-Device Identifier: 00763000006617
• UDI-Public: 00763000006617
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K140036
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2019

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: 03/11/2021
• Device Model Number: SA-85
• Device Catalogue Number: SA-85
• Device Lot Number: 0009638217
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/12/2019
• Supplement Date Received by Manufacturer: 08/07/2019
• Initial Report FDA Received Date: 07/30/2019
• Supplement Report FDA Received Date: 08/28/2019
• 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: 59 YR