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

Model Number	HG-16-62-28
Medical Device Problem Codes	Break (1069); Positioning Problem (3009)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/27/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Other relevant device(s) are: hg-16-62-28 lot # 49975050, use by date: 2018-07-31, udi # (b)(4) for device # 1, the guide was returned with the obturator inserted.Upon inspection of the guide, there was deformation to the tip of the guide 4 mm from the distal dip and was slightly oval in shape.The inner liner was also damaged, exposing the braid wires.The rest of the device was unremarkable.The knob was rotated; however, the tip of the heli-fx guide did not deflect.Both the obturator and an applier were successfully inserted through the guide with minor resistance.The handle of the guide was opened and the kevlar cord was found loosely wound around the reel.The kevlar cord was pulled and the entire length of the kevlar cord was able to be removed from the device.The kevlar loop which is typically secured around the support ring was severed just above the blue liner.For device # 2, the guide was returned with the obturator inserted.Upon inspection of the guide, there was deformation to the tip of the guide 4 mm from the distal dip and was oval in shape.The inner liner was also damaged, exposing the braid wires.The rest of the device was unremarkable.The knob was rotated; however, the tip of the heli-fx guide did not deflect.Both the obturator and an applier were successfully inserted through the guide with minor resistance.The handle of the guide was opened and the kevlar cord was found loosely wound around the reel.The kevlar cord was pulled and the entire length of the kevlar cord was able to be removed from the device.The kevlar loop which is typically secured around the support ring was severed just above the blue liner.The reported complaints were confirmed as the returned devices verified the heli-fx guides would not deflect when the knob was rotated due to the kevlar cord being severed.A portion of the kevlar cord not covered by the blue liner likely contacted a section of the metal braid wire, which ultimately severed the kevlar cord as the heli-fx guide was further deflected.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
An endurant ii stent graft system was implanted in a patient for the endovascular treatment of an abdominal aortic aneurysm.It was reported that after the stent graft was implanted there was a type i endoleak.The physician decided to use heli-fx endoanchors to resolve the endoleak.Two guides were used and both 28 guides broke while trying to get different angles.The physician used an endurant cuff and the endoleak resolved.Per the physician the cause of the break and the endoleak are unknown.No additional clinical sequelae were reported and the patient is fine.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: ENDO ANCHOR SYSTEM - HELI-FX AAA
• Common Device Name: ENDOVASCULAR SUTURING SYSTEM
• Manufacturer (Section D): MEDTRONIC CARDIOVASCULAR SANTA ROSA; 3576 unocal place; santa rosa CA 95403
• MDR Report Key: 6583383
• Report Number: 2953200-2017-00828
• Device Sequence Number: 943595
• Product Code: OTD
• UDI-Device Identifier: 00643169647626
• UDI-Public: 00643169647626
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K140036
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/27/2017

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: HG-16-62-28
• Device Catalogue Number: HG-16-62-28
• Device Lot Number: 49975036
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2017
• Initial Date Received by Manufacturer: 04/27/2017
• Supplement Date Received by Manufacturer: 04/27/2017
• Initial Report FDA Received Date: 05/22/2017
• Supplement Report FDA Received Date: 10/03/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 70 YR