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

Model Number	SA-85
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Pneumonia (2011)
Date of Event	11/18/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Information references the main component of the system.Other relevant devices are: sg-64 , s/n: (b)(4); use by date: 17-jul-2019; upn # (b)(4).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 abdominal aortic aneurysm.An endurant stent graft system was also implanted.Six endoanchors were deployed successfully, from the main body to the proximal neck.It was reported that approximately 2 months post the index procedure, the patient was diagnosed with pneumonia after experiencing shortness of breath.The patient also tested positive for e.Coli.The patient was treated with medication for the e.Coli and antibiotics for the pneumonia.Per the physician the event is not related to the device or procedure.The sponsor has assessed the event as possibly related to the procedure.The event is resolved.

• 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: 7244512
• Report Number: 2953200-2018-00191
• Device Sequence Number: 16405105
• Product Code: OTD
• UDI-Device Identifier: 00643169647695
• UDI-Public: 00643169647695
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K140036
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/06/2018

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2018
• Device Model Number: SA-85
• Device Catalogue Number: SA-85
• Device Lot Number: 50038025
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/17/2018
• Initial Report FDA Received Date: 02/06/2018
• 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: 81 YR
• Patient Weight: 82