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

Model Number	SA-85
Medical Device Problem Code	Device Difficult to Setup or Prepare (1487)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/08/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product analysis #(b)(4).Investigators present: (b)(6).The device was returned loose within an endovascular return kit.The catalog and lot numbers were verified from the returned paperwork.Both devices were returned bloodied.Upon inspection of the applier, there was a partially loaded endoanchor within the tip.The rest of the device was unremarkable.The handle was opened and no fluid or blood was observed within the handle.No corrosion was observed to the circuit board or connector pins.All wires and connectors within the handle appeared to be intact and properly connected.The battery was removed and measured 8.99v.The same battery was reattached and the device was restarted in manufacturing mode; after the error was cleared, the partially loaded endoanchor within the tip was able to be fully deployed.No abnormalities were observed.Within the housing tip, a broken endoanchor was found.The applier drive shaft was manually rotated to release the broken endoanchor.An endoanchor was loaded within the tip and deployed into silicone with no issue.The unable to load event was confirmed as there was a broken endoanchor within the tip that prevented another endoanchor from fully loading.The break likely occurred during deployment of the third 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.
Event or Problem Description
A heli-fx applier and endoanchors were used in the patient for the endovascular treatment of an abdominal aortic aneurysm.It was reported that during the index procedure, three endoanchors were successfully implanted.While trying to load the fourth endoanchor into the applier from the cassette, the device would not retract the endoanchor fully from the cassette.The event was resolved by opening another heli-fx applier.As per the physician the cause of the event was malfunction of the device.No additional 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 IRELAND; parkmore business park west; galway 95403
• MDR Report Key: 7185136
• Report Number: 2953200-2018-00069
• Device Sequence Number: 1812959
• Product Code: OTD
• UDI-Device Identifier: 00643169647695
• UDI-Public: 00643169647695
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 01/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2018
• Device Model Number: SA-85
• Device Catalogue Number: SA-85
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/19/2017
• Initial Report FDA Received Date: 01/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 82 YR
• Patient Weight: 93