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

Model Number SA-85

Device Problems Break (1069); Device Difficult to Setup or Prepare (1487)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/06/2017

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 of unknown size.A heli-fx applier and endoanchors were used in the endovascular treatment of a type ia endoleak in the patient.It was reported that the patient returned for follow up exam and a ct exam showed a type ia endoleak.It was noted that no migration of the stent graft was observed but that aortic neck dilatation had occurred, and this had effected the proximal seal.During the procedure after successful implantation of a 36mm endurant aortic cuff and 5 endoanchors, it was noted that on attempted loading of the 6th anchor, it would not load.After several unsuccessful attempts to load the 6th endoanchor involving pressing the forward and reverse mechanism multiple times, it was noted that a broken piece of an endoanchor exited the heli-fx applier.It was unknown when the fracturing of the endoanchor occurred.It was noted that the event was resolved with no further treatment.As per the physician the cause of the endoleak was due to anatomical dilatation of the aortic neck to 31.4mm.The existing 32mm bifurcation stent graft lacked the oversizing to successfully seal infrarenally.As per the physician, the cause of the endoanchor event was product related.No additional clinical sequelae were reported, and the patient is fine.

Manufacturer Narrative

Device evaluation summary the unable to load event was confirmed as there was a broken endoanchor within the tip that likely occurred during deployment of the fifth anchor.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 existed within this procedure that have historically been identified as causes of deployment resistance.These include difficulty positioning the heli-fx applier within highly angulated anatomy as well as calcification within the deployment zone.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ENDO ANCHOR SYSTEM - HELI-FX AAA
• Type of Device: ENDOVASCULAR SUTURING SYSTEM
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer Contact: ibrahim ibrahim ; 3576 unocal place; santa rosa, CA 95403 ; 7075917650
• MDR Report Key: 7137255
• MDR Text Key: 95914069
• Report Number: 2953200-2017-02021
• Device Sequence Number: 1
• Product Code: OTD
• UDI-Device Identifier: 00763000006617
• UDI-Public: 00763000006617
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/15/2019
• Device Model Number: SA-85
• Device Catalogue Number: SA-85
• Device Lot Number: 0008797647
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/02/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/15/2017
• 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: 74 YR