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

Model Number	SA-85
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Injury (2348)
Date of Event	08/24/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
Heli-fx aptus endoanchors were implanted as accessory devices for the endovascular treatment of a type ia endoleak from another manufacturer¿s stent graft.It was reported that during the intervention procedure, four endoanchors were implanted, resolving the endoleak.Approximately six months later, a type ia endoleak was observed.An intervention was performed approximately three weeks later.The physician performed a snorkel technique and implanted another manufacturer's aortic cuff; however, the event did not resolve.Per the investigator, the cause of the event was most likely related to the patient's anatomy.No additional clinical sequelae were reported and the patient is being monitored by the physician.

• Brand Name: ENDO ANCHOR SYSTEM - HELI-FX AAA
• Common Device Name: ENDOVASCULAR SUTURING SYSTEM
• Manufacturer (Section D): MEDTRONIC CARDIOVASCULAR; 3576 unocal place; santa rosa,ca
• MDR Report Key: 6912734
• Report Number: 2953200-2017-01546
• Device Sequence Number: 108939
• Product Code: OTD
• UDI-Device Identifier: 00643169647695
• UDI-Public: 00643169647695
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 09/06/2017

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: 05/31/2018
• Device Model Number: SA-85
• Device Catalogue Number: SA-85
• Device Lot Number: 49943081
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/06/2017
• Initial Report FDA Received Date: 10/03/2017
• 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: 79 YR
• Patient Weight: 54