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

Model Number	SG-64
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Injury (2348)
Date of Event	02/20/2018
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
An endurant stent graft system was implanted in a patient for the endovascular treatment of an unknown size abdominal aortic aneurysm.It was reported that 4 heli-fx endoanchors were implanted in the 79.2mm diameter aneurysm due to neck dilatation approximately 5 years later.An endurant ii limb extension was also implanted during the same procedure.Approximately 16 months post implantation of the endoanchors, it was noted that a type ia endoleak was observed.As per the investigator, the event was possibly related to the endograft.Approximately 17 months post implantation of the endoanchors, intervention to treat the type ia endoleak and aneurysm expansion was carried out, during the procedure ballooning was performed but the procedure was not completed successfully and the event was not resolved.A further re-intervention was carried out approximately 1 week later.During this procedure, an aortic cuff was implanted along with additional endoanchors and a non mdt stent.The procedure was successful and the event was resolved, no additional clinical sequelae were reported and the patient is fine.

• Brand Name: ENDO ANCHOR SYSTEM - HELI-FX AAA
• Common Device Name: ENDOVASCULAR SUTURING SYSTEM
• Manufacturer (Section D): MEDTRONIC CARDIOVASCULAR SANTA ROSA; 3576 unocal place; santa rosa CA 95403
• MDR Report Key: 7530040
• Report Number: 2953200-2018-00735
• Device Sequence Number: 1590469
• Product Code: OTD
• UDI-Device Identifier: 00643169647572
• UDI-Public: 00643169647572
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K140036
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/21/2018

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2018
• Device Model Number: SG-64
• Device Catalogue Number: SG-64
• Device Lot Number: 49945061
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/25/2018
• Initial Report FDA Received Date: 05/21/2018
• 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: 71 YR
• Patient Weight: 87