MAUDE Adverse Event Report: MEDTRONIC CARDIOVASCULAR SANTA ROSA 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 Code	Local Reaction (2035)
Date of Event	07/29/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Information references the main component of the system.Other relevant device(s) are: catalog # hg-16-62-28, lot # 49403027, use by date: 2017-08-31, manufactured date: 2015-08-05, and upn# (b)(4).
Event or Problem Description
A valiant stent graft system and heli-fx applier and guide were used for the endovascular treatment of a 60x120 mm thoracic aortic dissection and aneurysm.The iliac arteries were 6.5mm in diameter bilaterally.It was reported that the valiant stent grafts were inserted on the left femoral site and it is unknown what side the heli-fx was inserted.An ultrasound was performed as there was right groin pulsatile mass.The right groin pulsatile mass resolved without treatment.The physician reported site access problems and the patient had a right groin pulsatile mass.The patient was given a follow up ultrasound scan.The physician reported that the event resolved without treatment.The investigator assessed the event as related to the index procedure.No 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: 6943912
• Report Number: 2953200-2017-01565
• Device Sequence Number: 1141753
• 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): 09/15/2017

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2017
• Device Model Number: SA-85
• Device Catalogue Number: SA-85
• Device Lot Number: 49683070
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/15/2017
• Initial Report FDA Received Date: 10/12/2017
• 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: Other
• Patient Age: 82 YR
• Patient Weight: 60