MAUDE Adverse Event Report: MEDTRONIC SUNNYVALE/APTUS ENDOSYSTEMS ENDO ANCHOR SYSTEM - HELI-FX AAA; ENDOVASCULAR SUTURING SYSTEM

Model Number SA-85

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/19/2017

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

An endurant stent graft system was implanted in the patient for the endovascular treatment of an abdominal aortic aneurysm.It was reported that, during the index procedure, the endurant stent graft had a proximal type i endoleak.The physician elected to implant eight heli-fx endoanchors; however the endoleak was not resolved.It was also noted that, during the implant of the endoanchors, one of the endoanchors fractured.It was reported that during the procedure, another manufacturer¿s stent was implanted in the left renal artery for a chimney.There was no additional clinical sequelae reported and the patient is being monitored by their physician.

• Brand Name: ENDO ANCHOR SYSTEM - HELI-FX AAA
• Type of Device: ENDOVASCULAR SUTURING SYSTEM
• Manufacturer (Section D): MEDTRONIC SUNNYVALE/APTUS ENDOSYSTEMS; 271 gibraltar dr; sunnyvale CA 94089
• Manufacturer (Section G): MEDTRONIC SUNNYVALE/APTUS ENDOSYSTEMS; 271 gibraltar dr; sunnyvale CA 94089
• Manufacturer Contact: ibrahim ibrahim ; 3576 unocal place; santa rosa, CA 95403 ; 7075917650
• MDR Report Key: 6982779
• MDR Text Key: 90965252
• Report Number: 2953200-2017-01634
• Device Sequence Number: 1
• Product Code: OTD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140036
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,study
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SA-85
• Device Catalogue Number: SA-85
• Device Lot Number: 0008707260
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/02/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 84 YR
• Patient Weight: 38