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

Model Number HA-18-114

Device Problems Difficult to Insert (1316); Malposition of Device (2616); Device Dislodged or Dislocated (2923)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 11/06/2019

Event Type  Injury  

Manufacturer Narrative

Film evaluation summary: the exact cause of the reported events could not be determined from the films provided.The reported possible type ia endoleak was confirmed from the ct¿s from 30 months post-implant; however, the cause could not be determined.The pre-implant anatomy is unknown, images during implant were not provided, and earlier post-implant ct¿s were not provided for comparison.It is possible that disease progression (proximal neck dilatation) may have led to a poor proximal seal.The applier is pending return for analysis and the results will be summarized in a separate report.The reported dislodged endoanchor was confirmed.The cause of the dislodgment, reported as occurring during the second phase of deployment, could not be determined from the films provided.Images during implant of the endoanchors were not available for review.It is possible that this was anatomical related; implanting within irregular or eccentric thrombus, calcification, and/or plaque may compromise endoanchor penetration or fixation.Possible procedural related causes include not positioning the guide and applier 90° perpendicular to endograft, engaging areas of loose fabric or fabric not in apposition to the native vessel wall or engaging a stent, and not maintaining constant position, pressure and support throughout the endoanchor deployment sequence.If information is provided in the future, a supplemental report will be issued.

Event Description

A valiant stent graft system was implanted in a patient for the endovascular treatment of a thoracic aortic aneurysm of unknown size.It was reported that approximately 2 years 8 months post index procedure, due to distal aortic dilation a valiant navion stent graft was implanted as an extension.The physician elected to implant endoanchors due to a possible type ia endoleak observed at the very proximal margin however it was noted that the endoleak did not appear to be filling the sac.The endoanchors were planned to be placed along the lesser curve of the aorta at the proximal margin of the prior valiant captivia implant distal to the lcc/lsa.During placement of the endoanchor, it was initially deployed and penetrated the fabric.The second phase of deployment was performed but the endoanchor dislodged and remained suspended in the arch for a few seconds before disappearing into the rcc or lcc.8 additional endoanchors were placed in total, 7 successfully as planned.The 6th endoanchor was not deployed successfully.As per the physician, the cause was product related.The cause of the type ia endoleak was not confirmed.No additional clinical sequelae were reported and the patient will be monitored.

Manufacturer Narrative

Additional information received reported that the physician stated there was a small evidence of contrast along the inner curve at the time of the original implant but the contrast wasn¿t evident in the aneurysm sac.They observed a small gap along the inner curve on the current ct, suggesting the value of securing the graft to the inner curve to mitigate endotension.The distal dilation was not associated with the proximal device, but rather was associated with the distal valiant captivia vamc3430c150 (b)(4).The valiant navion stent graft was implanted as a distal extension of this device.It was reported that the 6th endoanchor was not deployed successfully, and remains lodged in the patient's distal carotid artery.It was noted that the endoanchor was not retrievable.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: 9401322
• MDR Text Key: 168802086
• Report Number: 9612164-2019-04987
• Device Sequence Number: 1
• Product Code: OTD
• UDI-Device Identifier: 00763000225940
• UDI-Public: 00763000225940
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140036
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2021
• Device Model Number: HA-18-114
• Device Catalogue Number: HA-18-114
• Device Lot Number: 0009808123
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 11/07/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/04/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2019
• 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 Outcome(s): Required Intervention
• Patient Age: 82 YR