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); Pain (1994)
Date of Event	06/29/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Other relevant devices are: sg-64; s/n: unknown; use by date: unknown; upn # unknown.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The 9 heli-fx endoanchors were implanted in a patient for the treatment of a type ia endoleak in another manufacturer's stent graft system used for the endovascular treatment of a 6cm abdominal aortic aneurysm.It was reported that the procedure was an overall success.However, it was reported that the patient developed a urinary tract infection that was assessed by the investigator as probably related to the index procedure.Patient was urinating frequently and had lower back pain.The patient was treated with medication.It is noted that the patient symptoms have resolved and that the event is resolved.No further clinical sequelae were reported.

• 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: 7291566
• Report Number: 2953200-2018-00275
• Device Sequence Number: 16453322
• Product Code: OTD
• UDI-Device Identifier: 00643169647695
• UDI-Public: 00643169647695
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 02/23/2018

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: 04/30/2019
• Device Model Number: SA-85
• Device Catalogue Number: SA-85
• Device Lot Number: 50188053
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/31/2018
• Initial Report FDA Received Date: 02/23/2018
• 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: 84 YR
• Patient Weight: 68