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

Model Number HA-18-114

Device Problem Difficult to Insert (1316)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/03/2018

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

A heli-fx endoanchoring system was used prophylactically in a patient as an accessory device with non-mdt stent graft for an unknown thoracic endovascular treatment.It was reported the endoanchors were implanted at the distal end of the stent graft.It was reported that a 32mm guide was selected and one endoanchor was successfully implanted but while attempting to implant the second endoanchor it was reported the applier was unable to advance out of the guide.Per the physician, the cause of the event was product related and not due to user error.It was noted that the physician was being very careful not to over manipulate or over torque the guide.It was also reported that the markers on the guide appeared distorted under fluoroscopy when attempting to position the guide.The linear marker on the guide appeared to have moved so the markers looked like they had more of an acute angle rather than 90 degrees.Another 32mm heli-fx guide was then used instead but distortion of the markers was also reported with this guide.A 42mm heli-fx guide was then used to successfully complete the procedure.Per the physician, the cause of the event was product related and not due to user error.It was noted that the physician was being very careful not to over manipulate or over torque the guide no additional clinical sequelae were reported and the patient is fine.

Manufacturer Narrative

Additional information received reported that it was confirmed that the case was a thoraco-abdominal aneurysm (taaa) and endoanchors were used in the distal part of the stent graft.The diameter at the bottom of the aorta was 33-34mm with no tortuosity noted.Non-medtronic stent grafts inserted were all 40mm in diameter - the top was 40x100mm, middle 40x150mm and bottom 40x200 mm.Film evaluation summary: the cause of the report of the applier unable to be advanced out of the guide during the second anchor implant, as well as the markers on the guide appearing distorted under fluoroscopy during positioning, could not be determined from the limited images returned.Films during implant were not available for return; therefore, the reported events could not be assessed.Analysis of the returned films did not reveal any endoanchor or anatomical characteristics that could explain the reported event.A device issue cannot be ruled out as a potential cause.The guides have been returned for investigation and are pending analysis.The results will be summarized in a separate report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ENDO ANCHOR SYSTEM - HELI-FX TAA
• 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: alison sweeney ; parkmore business park west; galway ; 091708096
• MDR Report Key: 7905708
• MDR Text Key: 121722523
• Report Number: 2953200-2018-01347
• Device Sequence Number: 1
• Product Code: OTD
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K140036
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/20/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2018
• Device Model Number: HA-18-114
• Device Catalogue Number: HA-18-114
• Device Lot Number: 50113009
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/03/2018
• Initial Date FDA Received: 09/25/2018
• Supplement Dates Manufacturer Received: 10/23/2018
• Supplement Dates FDA Received: 11/20/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/15/2016
• 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