MAUDE Adverse Event Report: MEDTRONIC IRELAND VALIANT NAVION; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TR

Model Number	VNMF3737C174TU
Medical Device Problem Codes	Leak/Splash (1354); Migration or Expulsion of Device (1395); Material Deformation (2976)
Health Effect - Clinical Code	Pain (1994)
Date of Event	12/17/2020
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 the endovascular treatment of a ruptured thoracic aortic aneurysm.It was reported on the date of the ct approximately 17 months post implant, a potential type iiib or type ia endoleak was present in the proximal area of the graft.The aneurysm had expanded from 50mm to 70mm.Intervention was performed and the stent graft was relined proximally.It also was stated there looked to be stent ring enlargement in a different area of the graft it was reported it was reported it looked like the stent had come off the graft.The patient had been complaining of chest pain.A ct was performed post the secondary procedure and it was noted the aneurysm had enlarged further so there may be still an endoleak, although the physician noted there was nothing obvious on the completion angiogram after the intervention.No cause was reported.No additional clinical sequelae were provided and the patient will be monitored.
Additional Manufacturer Narrative
H9 continued: (b)(4).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
Film evaluation summary the reported endoleak and aneurysm enlargment was confirmed on the films provided; however the cause of the events could not be fully determined.The stent graft enlargement was observed and was confirmed via the requested external corelab review for this event.The anatomy at implant is unknown and angiograms (including endoleak interrogation) could allow for a more comprehensive determinations of the endoleak source/cause.Although a type ii or type iiib endoleak could not be fully ruled out, it is most likely that the endoleak observed was a proximal type ia endoleak.Analysis of the returned films did not reveal any obvious anatomical anomalies that may have led to a type iiib endoleak (e,g, calcification).It is possible that lack of adequate proximal seal or aneurysm morphology changes over the duration of implantation of the device may have contributed to the occurrence of a proximal endoleak.Additional information received; it was confirmed that the intervention performed was the implantation of a valiant navion stent graft to resolve the endoleak on 27 jan 2021.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
Additional information received:1 it was reported the patient presented emergently on (b)(6) 2021 with severe chest pain.The patient was given a heart cath but the patient was still experiencing severe pain, a ct showed a type ia endoleak.*it was noted that the patient had had a 3 intervention on an unknown date (after the (b)(6) 2021 intervention) where a non mdt (gore) stent graft was implanted at some point in the proximal portion of the graft.The graft was placed at the level of the left carotid and a proximal type 1 endoleak was present.* intervention was performed the same day where a procedure to debranch the proximal aorta was performed.The patient was taken to the or where a graft was placed on the proximal ascending arch to the great vessels.After thatprocedure the patient was transferred to the hybrid lab where the physician placed a 46x46x200 valiant down the ascending landing down to the bypass.The distal end of the graft landed in the mid portion of the previous implanted devices.The post angiogram showed no endoleak.The procedure was completed and the patient was removed from the or on (b)(6) 2021 the ct was reviewed as it was reported the patients chest tube had filled with blood, it was determined the type ia was still present.Another intervention was performed on (b)(6) 2021 where an additional 46x46x200 device was implanted, it was reported the physician performed a cut down in order to get extra length for the device to get closer to the bypass graft, the graft and junctions were then aggressively ballooned and the procedure was completed.It was reported per the physician the cause of the endoleak was anatomy due to aneurysmal degeneration.No additional clinical sequalae were reported and the patient is fine 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
The core lab review of imaging from (b)(6)2021 (12 month follow up) showed aortic enlargment, no endoleak, no fractures and yes;no to stent enlargment.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
It was reported the corelab observed a type ia on the 1 year follow up ct taken on (b)(6) 2020.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
Additional information received: core lab review of ct imaging from (b)(6) 2020 identified a new type ia endoleak on the navion graft (b)(6) ((b)(6)).No stent fractures were observed.New stent ring enlargement of +3.3mm and 1.5mm were observed on (b)(6) ((b)(6)).New stent ring migration of +4.3mm was identified on (b)(6) ((b)(6)).The imaging was noted as na for aortic enlargement.Core lab review of ct imaging from (b)(6) 2021 identified no endoleaks or no stent fractures.Persistent stent ring enlargement of 5.9mm and 1.8mm were observed on (b)(6) ((b)(6)).Persistent stent ring migration of +9.1 was identified on (b)(6) ((b)(6)).Aortic enlargement of +11.1mm was observed.It was additionally noted by the core lab the new sre and srm found on the images for both (b)(6) 2020 and (b)(6) 2021 are located on stent ring #6 of (b)(6) ((b)(6)).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: VALIANT NAVION
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TR
• 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: 11580173
• Report Number: 9612164-2021-01191
• Device Sequence Number: 4150406
• Product Code: MIH
• UDI-Device Identifier: 00763000100681
• UDI-Public: 00763000100681
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: P100040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 10/25/2022

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: 09/09/2020
• Device Model Number: VNMF3737C174TU
• Device Catalogue Number: VNMF3737C174TU
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 02/26/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 02/26/2021
• Supplement Date Received by Manufacturer: 03/02/2021; 05/19/2021; 08/10/2021; 08/25/2021; 11/09/2021; 10/24/2022
• Initial Report FDA Received Date: 03/27/2021
• Supplement Report FDA Received Date: 04/09/2021; 06/08/2021; 09/07/2021; 09/23/2021; 11/16/2021; 10/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/10/2018
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-1201-2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR
• Patient Sex: Male