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

Model Number VNMC3434C182TU

Device Problems Fracture (1260); Leak/Splash (1354); Positioning Problem (3009)

Patient Problems Hemorrhage/Bleeding (1888); High Blood Pressure/ Hypertension (1908); Unspecified Infection (1930); Pain (1994); Rupture (2208); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 04/04/2023

Event Type  Injury  

Manufacturer Narrative

Medtronic received the following information from a journal article entitled; two endovascular stent graft repairs needed for an ext rathoracic aortic graft: distant complications after an original open repair for a gunshot wound to the chest kiely k & arko f tex heart inst j.2023;50(2):e227850.Doi:10.14503/thij-22-7850.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.

Event Description

A patient 15 years previously underwent a median sternotomy and a left posterolateral thoracotomy with replacement of the descending aorta using a prosthetic graft for a gun shot wound.In (b)(6) 2019, the patient presented to an outside hospital with acute abdominal pain.A ct performed demonstrated acute thrombosis of the celiac artery and superior mesenteric artery (sma), and the patient underwent exploratory laparotomy, thromboendarterectomy of the sma, and a common iliac¿to-sma bypass using polytetrafluoroethylene graft.A preoperative ct had partially captured a pseudoaneurysm of the descending aorta with extension through the posterolateral chest wall.A ct angiogram of the chest wall was then performed and showed a chronic type a dissection involving the innominate, left carotid, and left subclavian arteries and showed the surgical replacement of the descending aorta.The posterior chest wall was disrupted from the previous gunshot wound, and the aortic graft was extending posteriorly into the chest wall muscles.There was pseudoaneurysm formation in the extra thoracic portion of the graft, with mural thrombus; this was thought to be the likely source of the patient¿s sma thrombus.The patient was transferred to another institution where a tevar was performed.The right common femoral artery was accessed percutaneously, and the left common femoral artery was explored in an open fashion with open thrombectomy, endarterectomy, and patch angioplasty.Initially, it was difficult to track the endograft device through the extra thoracic aorta, so a 20f sheath was advanced over a dilator through the extrathoracic aorta into the proximal descending aorta.From there, the device was advanced through the sheath to the desired deployment zone and a 34 x 34 x 182 mm valiant navion stent graft was deployed.Intravascular ultrasound demonstrated good wall apposition and no evidence of extrinsic luminal compression by the ribs.Post operatively the patient developed bleeding from the proximal anastomosis of the common iliac¿ to-sma bypass which was managed with endovascular stenting.The patient developed a would infection in the left groin operative site that required multiple operative irrigations and debridements and a rectus femoris muscle flap for coverage.The patient also experienced multiorgan failure that required reintubation and prolonged ventilator support, nutritional support, placement of a feeding jejunostomy, and kidney replacement therapy via a tunneled hemodialysis catheter.The patient was discharged home on postoperative day 99 after tevar and was then lost to follow-up.He returned to the emergency department in (b)(6) 2020,1 year after surgery, with chest pain radiating to his back.The patient had hypertension on arrival but afebrile and hemodynamically stable, but was also noted to be anemic.A ct angiogram of the chest demonstrated a fracture of the valiant navion stent graft with contained rupture into the left posterolateral chest wall.The patient underwent emergency treatment.Unilateral right common femoral artery percutaneous access was used and two non mdt stent grafts were implanted as treatment across the fractured stent and an additional stent graft was deployed to extend the proximal seal zone to just distal to the origin of the left subclavian artery.To extend the distal seal zone a final 34 x 24 x 90 mm valiant navion was deployed.Post endograft angiography demonstrated good exclusion of the rupture.The patient did well postoperatively and was discharged home on postoperative day 2.For a cause of the type iiib endoleak secondary to stent graft fracture, it is said that an inherent defect in the structural integrity of the endograft may have contributed to its eventual graft disruption , stent fracture, and contained rupture.Although intraoperative intravascular ultrasound during the index procedure did not demonstrate extrinsic compression of the stent graft by the ribs, it is possible that chest wall excursion and extrinsic friction may have also contributed to this rupture.It was also suggested that the initial indication for tevar is likely a major contributing factor in predicting endograft failure , therefore, this patient¿s initial off-label and unique indication for tevar was likely a contributing factor to the subsequent acute rupture, in addition to the inherent defects in the endograft.No additional clinical sequalae were provided and the patient is fine.

Manufacturer Narrative

Continued from h9: 3005364322-02-19-2021-001-r.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
• Type of Device: 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: 17548024
• MDR Text Key: 321141945
• Report Number: 9612164-2023-03695
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 11/07/2023

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
• Device Operator: Health Professional
• Device Model Number: VNMC3434C182TU
• Device Catalogue Number: VNMC3434C182TU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/31/2023
• Initial Date FDA Received: 08/15/2023
• Supplement Dates Manufacturer Received: 11/07/2023
• Supplement Dates FDA Received: 11/07/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: SEE H10
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 54 YR
• Patient Sex: Male