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

Model Number	SA-85
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Death (1802)
Date of Event	03/25/2019
Type of Reportable Event	Death
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
A heli-fx endoanchoring system was used along with the implantation of a non-mdt stent graft in the endovascular treatment of a maximum diameter 62mm abdominal aortic aneurysm.Six endoanchors were implanted to the main body of stent graft to proximal neck primarily in the prevention of neck dilation.The patient was discharged the next day.Two years later, a type ia endoleak with enlarging aaa sac and penetrating ulcer in descending thoracic aorta was observed.The patient was given medication.The patient had abdominal pain in association with this.This event was assessed by the site as unlikely related to the index procedure, possibly related to device (uncertain which device) and related to the aneurysm treated by the endoanchors.There was a plan was to intervene with endoanchors however the patient has multiple co morbidities of chf and ckd iv, making surgical intervention high risk.A few days later, the type ia endoleak was increasing and was deemed by the site as related to the aneurysm treated by the endoanchors.Two years and eight months later post the index procedure, the patient expired under hospice care.The death was deemed related to the event.No additional clinical sequelae were provided and the patient is expired.

• Brand Name: ENDO ANCHOR SYSTEM - HELI-FX AAA
• Common Device Name: ENDOVASCULAR SUTURING SYSTEM
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway ; IE
• MDR Report Key: 10028971
• Report Number: 9612164-2020-01799
• Device Sequence Number: 3776004
• Product Code: OTD
• UDI-Device Identifier: 00643169647695
• UDI-Public: 00643169647695
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 05/06/2020

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: 01/31/2019
• Device Model Number: SA-85
• Device Catalogue Number: SA-85
• Device Lot Number: 50136012
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/17/2020
• Initial Report FDA Received Date: 05/06/2020
• 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: Death
• Patient Age: 82 YR
• Patient Weight: 91