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

Model Number	HA-18-114
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Death (1802); Device Embedded In Tissue or Plaque (3165)
Date of Event	11/02/2017
Type of Reportable Event	Death
Additional Manufacturer Narrative
Films review summary the exact cause of the reported 2 ¿floating¿ endoanchors could not be determined from the limited still films provided.Additional images during implant, including films during endoanchor implant when the event occurred, were not available for review.Ct¿s were also not available to provide a more complete evaluation of the patient¿s thoracic anatomy.The intended anchor target along the right-lateral stent graft appeared to be in good apposition with the thoracic.It is unclear if the angulated/tapered appearance along the right side of the distal bare spring, just below the intended endoanchor target, may have contributed the event by causing this fabric above the bare spring to infold and possibly pull away from the thoracic wall, leading to the mis-deployed anchors.Evaluation of the device was not performed as the device was not available for return and analysis.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
A heli-fx applier and endoanchors were used prophylactically as an accessory device for the endovascular treatment of the patient with a valiant stent graft system.It was reported that during the index procedure, the physician placed the heli- fx guide in the appropriate location to deploy an endoanchor in the right lateral wall of the descending thoracic aorta, just above the celiac.After deploying the endoanchor to the first stage, it was determined that it was in a good position.When the endoanchor was fully deployed, it appeared to "float" behind the existing stent graft and settled in the descending aneurysm sac behind the stent graft.A second endoanchor was then placed by the physician in a similar location and it also appeared to "float" through the stent graft wall to a similar location.It was noted that placement of the endoanchors in the left aspect of the stent graft was successful.As per the physician, the cause of the endoanchor event was product related.It was reported that, 6 days post index procedure, the patient had a cardiac event during routine exercise with the registered nurse and died after cpr.No additional clinical sequelae were reported.It was reported that no additional information will be released in relation to this event.

• Brand Name: ENDO ANCHOR SYSTEM - HELI-FX TAA
• Common Device Name: ENDOVASCULAR SUTURING SYSTEM
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 7056725
• Report Number: 2953200-2017-01854
• Device Sequence Number: 126972
• Product Code: OTD
• UDI-Device Identifier: 00763000006648
• UDI-Public: 00763000006648
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K140036
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/26/2019
• Device Model Number: HA-18-114
• Device Catalogue Number: HA-18-114
• Device Lot Number: 0008687963
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/02/2017
• Initial Report FDA Received Date: 11/23/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 73 YR
• Patient Weight: 72