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

Model Number HG-18-90-32

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/09/2018

Event Type  malfunction  

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 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.

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
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; 091708096
• MDR Report Key: 7487511
• MDR Text Key: 107587776
• Report Number: 2953200-2018-00650
• Device Sequence Number: 1
• Product Code: OTD
• UDI-Device Identifier: 00763000025281
• UDI-Public: 00763000025281
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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,Followup
• Report Date: 08/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/09/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/24/2017
• 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: 81 YR