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

Model Number	HA-18-114
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	01/21/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Film evaluation summary:   the reported migration of endoanchors into the aneurysm sac could not be confirmed on the films provided, therefore, the cause of the event could not be determined.Lack of pre-implant ct¿s did not allow for a thorough assessment of the pre-implant anatomy.Procedural angiogram showing attempts to deploy the device were not received for thorough analysis of the event. it is possible that the radiopaque body observed at the level of the distal graft was an endoanchor, but this could not be confirmed.A compatibility issue cannot be ruled out as contributory factor for the reported event.As per the ifu, the non-medtronic stent graft implanted in the patient is not included in the list of endografts that have been evaluated for compatibility with endoanchors.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Heli-fx endoanchors were implanted to attempt to gain distal seal in a non md stent graft.  it was reported that during the index procedure when deploying the endoanchors, two endoanchors embolized and travelled into the aortic sac during deployment.The physician thought they had engaged the aortic wall but they had not.The endoanchors remain floating in the aortic sac.  as per the physician the cause of the event could not be determined.No additional clinical sequalae was provided and the patient will be monitored.
Event or Problem Description
Heli-fx endoanchors were implanted to attempt to gain distal seal in a non md stent graft.  it was reported that during the index procedure when deploying the endoanchors, two endoanchors embolized and travelled into the aortic sac during deployment.The physician thought they had engaged the aortic wall but they had not.The endoanchors remain floating in the aortic sac.  as per the physician the cause of the event could not be determined.No additional clinical sequalae was provided and the patient will be monitored.
Additional Manufacturer Narrative
Film evaluation summary: the reported migration of endoanchors into the aneurysm sac could not be confirmed on the films provided, therefore, the cause of the event could not be determined.Lack of pre-implant ct¿s did not allow for a thorough assessment of the pre-implant anatomy.Procedural angiogram showing attempts to deploy the device were not received for thorough analysis of the event. it is possible that the radiopaque body observed at the level of the distal graft was an endoanchor, but this could not be confirmed.A compatibility issue cannot be ruled out as contributory factor for the reported event.As per the ifu, the non-medtronic stent graft implanted in the patient is not included in the list of endografts that have been evaluated for compatibility with endoanchors.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ENDO ANCHOR SYSTEM - HELI-FX TAA
• Common Device Name: ENDOVASCULAR SUTURING SYSTEM
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 13540093
• Report Number: 9612164-2022-00624
• Device Sequence Number: 3695924
• Product Code: OTD
• UDI-Device Identifier: 00763000225940
• UDI-Public: 00763000225940
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K140036
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/16/2022

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: 05/28/2022
• Device Model Number: HA-18-114
• Device Catalogue Number: HA-18-114
• Device Lot Number: 0010261926
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/21/2022
• Initial Report FDA Received Date: 02/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/28/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 69 YR
• Patient Sex: Male