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

Model Number	HA-18-114
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Ischemia (1942)
Date of Event	03/08/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Other relevant device(s) are: product id: hg-18-90-32, serial/lot #: (b)(4), ubd: unknown, udi #: unknown.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Heli-fx endoanchors were implanted prophylactically in a patient for the endovascular treatment of a 45 mm diameter abdominal aortic aneurysm.A non-medtronic stent graft system was implanted on the same day.It was reported that right lower extremity ischemia was observed on the day of the index procedure.The patient was treated with a lower extremity arterial intervention and the event was resolved.The investigator assessed the event as not related to the study devices or procedure.The sponsor assessed the event as probably related to the study procedure, not related to the study device.No additional clinical sequelae were reported and the patient is fine.
Additional Manufacturer Narrative
Other relevant device(s) are: product id: hg-18-90-32, serial/lot#: (b)(4), ubd: (b)(4) 2019, udi#: (b)(4).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: 9232685
• Report Number: 9612164-2019-04494
• Device Sequence Number: 18937071
• Product Code: OTD
• UDI-Device Identifier: 00763000006648
• UDI-Public: 00763000006648
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K140036
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/19/2019

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 12/12/2019
• Device Model Number: HA-18-114
• Device Catalogue Number: HA-18-114
• Device Lot Number: 0008918411
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/16/2019
• Supplement Date Received by Manufacturer: 10/24/2019
• Initial Report FDA Received Date: 10/24/2019
• Supplement Report FDA Received Date: 11/19/2019
• 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: 72 YR
• Patient Weight: 77