MAUDE Adverse Event Report: MEDTRONIC IRELAND ENDO ANCHOR SYSTEM - HELI-FX TAA

Model Number	HG-18-90-32
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/09/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Continuation of medical devices: information references the main component of the system.Other relevant device(s) are: product id: hg-18-90-42, serial/lot #: (b)(4), ubd: 24-oct-2019, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
A heli-fx applier and endoanchors were planned to be used in a patient for the endovascular treatment of a type ia endoleak of a non-mdt thoracic stent graft along with penumbra coils and onyx.It was reported that heli-fx guide hg-18-90-32 (lot number 0008847767) broke during the procedure, that the catheter didn¿t turn, and the handle was separated from the catheter.The physician reported the cause of the event to be product related and reported low quality of the product along with complex anatomy due to angulation.A second heli-fx guide g-18-90-32 (lot number 0008847776) was also used during the procedure.It was reported that this heli-fx guide also broke during the procedure, that the catheter didn¿t turn, and the handle was separated from the catheter.Again, the physician reported the cause of the event to be product related and reported low quality of the product along with complex anatomy due to angulation.No additional clinical sequelae were reported, and the patient is fine.
Additional Manufacturer Narrative
Device evaluation summary: the device returned with the handle detached.The braid wire and lumen liner material were exposed at the proximal end of the pebax jacket.The liner material was jagged and uneven at the break point.The handle was disassembled.The kevlar break point was visible.A section of braid wire and liner material remained on the stainless-steel lumen.The guide tip was deformed with exposed braid wire visible inside the tip.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ENDO ANCHOR SYSTEM - HELI-FX TAA
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 7487511
• Report Number: 2953200-2018-00650
• Device Sequence Number: 1313887
• Product Code: OTD
• UDI-Device Identifier: 00763000025281
• UDI-Public: 00763000025281
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K140036
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/10/2018

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: 10/24/2019
• Device Model Number: HG-18-90-32
• Device Catalogue Number: HG-18-90-32
• Device Lot Number: 0008847767
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2018
• Initial Date Received by Manufacturer: 04/09/2018
• Supplement Date Received by Manufacturer: 08/09/2018
• Initial Report FDA Received Date: 05/04/2018
• Supplement Report FDA Received Date: 08/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 81 YR