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 Codes	Stroke/CVA (1770); Embolism (1829); Embolism/Embolus (4438)
Date of Event	01/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
A valiant navion stent graft was implanted in an unknown endovascular procedure on an unknown date.It was reported on an unknown date months later, a type ia endoleak occurred.Intervention was performed where a total of 8 endoanchors were implanted of which 2 were said to be not optimally placed due to the physician being a 1st time user of the endoanchoring system & there being time pressure due to cardiac events that occurred in the procedure.The patient suffered from an air embolism in the aortic arch and was said to be stable by the end of the procedure.The next morning the patient awoke with a stroke.As per the physician the cause of the event could not be determined.No additional clinical sequelae were provided and the patient will be monitored.
Additional Manufacturer Narrative
B:5 additional information received; it was confirmed that the type ia endoleak was identified on 1 month follow up.A:2 updated 2:3 updated.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.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.
Additional Manufacturer Narrative
Medtronic received the following information obtained from the journal article titled; caution: air embolism related to heli-fx endoanchor system in zone 2 thoracic aneurysm repair, cristian rosu, ricardo ruz, charles overbeek, stéphane elkouri doi.Org/10.1177/15266028211062562.Patient was admitted with a type 1a endoleak approximately 9 months after hybrid treatment of a saccular proximal descending thoracic aorta aneurysm (dtaa).A left common carotid artery (lcc) to left subclavian artery (lsc) bypass was performed and a valiant navion thoracic endograft was deployed in zone 2.The proximal lsc artery was embolized with an non-medtronic vascular plug.The intervention and recovery were uneventful.An endoleak was present on the first postoperative computed tomographic angiogram (cta) performed 1 month later.The precise origin of this endoleak could not be determined.It was decided not to intervene and a follow-up scan was planned 6 months later.In the interim, the patient developed worsening hoarseness with left vocal cord paralysis.Repeat cta confirmed an enlarging 8 cm dtaa and a persistent endoleak.A conventional angiogram confirmed a type 1a endoleak and severe narrowing of the lcc artery at its origin due to encroachment by the endograft.The patient was neurologically asymptomatic.Reintervention was performed.Under general anesthesia, open left brachial artery access was obtained, and the ascending aorta was c annulated through the carotid-subclavian bypass.A 6-french (fr) sheath was positioned into the proximal lcc and the patient was heparinized.A right transfemoral percutaneous approach was used to insert an 18 f sheath and a pigtail catheter.Aortography confirmed a persistent type 1a endoleak.The patient was hemodynamically stable at this time.The plan was to use the thoracic heli-fx endoanchor system to treat this endoleak by improving the apposition of the endograft to the aortic wall.The deflectable heli-fx guiding sheath was flushed with heparinized saline as per the manufacturer¿s instructions for use (ifu) and advanced over a non-medtronic wire into zone 2 in the proximal portion of the previously placed navion endograft.Using an orthogonal view, 2 endoanchors were deployed on the inner curve with no difficulty as per ifu.At that moment, the patient presented ischemic electrocardiogram (ekg) abnormalities with rapidly increasing st-segment elevations, mainly in the inferior leads and became severely hypotensive.Hemodynamic changes were partially corrected with increasing doses of norepinephrine and boluses of epinephrine.On angiogram, there was no evidence of aortic dissection or iliac access bleeding.A transesophageal echocardiography (tee) probe was quickly inserted and demonstrated severe hypokinesis of the right ventricle, as well as of the inferior and inferoseptal walls of the left ventricle.There was no pericardial effusion.Tee demonstrated large amounts of air in the ascending aorta, suggesting that the wall motion abnormalities were due to air embolism in the right coronary artery.No air was seen in the left atrium or left ventricle.The table was put into trendelenburg position.After 10 minutes of hemodynamic support and with air disappearing from the ascending aorta, the patient¿s hemodynamics completely stabilized, and all inotropic and vasopressor supports were weaned.Significant systemic hypertension was present for several minutes.The wall motion abnormalities resolved, with normal systolic function of both the right and left ventricles at the end of the intervention.A complete tee evaluation was performed and demonstrated no intracardiac sources for a right to left shunt.Due to concern regarding left cerebral hemispheric hypoperfusion during the period of hemodynamic instability due to the severe lcc ostial stenosis, the lcc was rapidly stented with an 8 mm × 29 mm balloon expandable non-medtronic stent.Once hemodynamic stability was re-established, 6 additional endoanchors were deployed to the proximal part of the navion graft.Finally, balloon molding was performed simultaneously of the lcc stent and of the proximal endograft in zone 2.Angiogram revealed widely patent lcc and resolution of the endoleak.Given that the patient was stable, extubation was attempted at the conclusion of the procedure.The patient emerged from general anesthesia with unmanageable agitation despite administration of sedatives.The physical exam also demonstrated a new paresis of the right upper limb.The patient was reintubated and taken for a ct scan of the head which revealed slight edema of the left posterior brain with no evidence of air embolism.Cta revealed no cerebral vessel occlusions.The thoracic aortic aneurysm sac was shown to be thrombosed with no evidence of endoleak.The patient was discharged from the hospital 2 weeks later with minimal sequelae.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.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.

• Brand Name: ENDO ANCHOR SYSTEM - HELI-FX TAA
• Common Device Name: 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: 10746507
• Report Number: 9612164-2020-04102
• Device Sequence Number: 19695539
• Product Code: OTD
• UDI-Device Identifier: 00763000225940
• UDI-Public: 00763000225940
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K140036
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/22/2021

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: 03/03/2022
• Device Model Number: HA-18-114
• Device Catalogue Number: HA-18-114
• Device Lot Number: 0010161523
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 10/22/2020
• Supplement Date Received by Manufacturer: 10/29/2020; 12/17/2021
• Initial Report FDA Received Date: 10/28/2020
• Supplement Report FDA Received Date: 11/25/2020; 12/22/2021
• Date Device Manufactured: 03/03/2020
• 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: 71 YR
• Patient Sex: Male