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 06/21/2017

Event Type  malfunction  

Manufacturer Narrative

Device evaluation: the complaint was confirmed as the inability to load was due to the broken endoanchor found within the tip of the applier.The exact cause of the broken endoanchor cannot be conclusively determined.Based on historical analysis of similar broken endoanchor complaints, there is no evidence of a material defect that would have been contributory.Conditions during the procedure that have historically been identified as causes of deployment resistance include difficulty positioning the heli-fx applier within highly angulated anatomy as well as calcified plaque or thrombus with more than 2mm of thickness within the deployment zone.In addition, encountering a stent strut may have also contributed to the event.

Event Description

Heli-fx endosystem was prophylactically used during an endovascular procedure.The heli-fx endosystem was used with a medtronic stent graft.There was no calcification present.It was reported that during the index procedure, the physician was able to implant three endoanchors, but while loading the fourth one, the applier stopped working.The fourth endoanchor was loaded with half of it sticking outside of the applier d-drive.The physician attempted to reload the endoanchor but was still seeing the same issue.As a result, the physician used another applier and the procedure was successfully completed.Per the physician, the cause of the event was related to the device.No clinical sequelae were reported and the patient is fine.

• 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: 6967943
• MDR Text Key: 90683085
• Report Number: 2953200-2017-01612
• Device Sequence Number: 1
• Product Code: OTD
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K140036
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2018
• Device Model Number: SA-85
• Device Catalogue Number: SA-85
• Device Lot Number: 50124022
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/18/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/13/2016
• 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