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

Model Number UNK-CV-SR-VALIANT

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Ischemia (1942); Paresis (1998)

Event Date 04/05/2023

Event Type  Injury  

Manufacturer Narrative

Medtronic received the following information from a journal article entitled; unusual presentation of acute ruptured penetrating aortic ulcer of descending thoracic aorta with right hemothorax eckholdt c., pennywell d., white r.K., perkowski p.E.Journal of vascular surgery cases, innovations and techniques (2023) 9:2 article number: 101176.Doi; 10.1016/j.Jvscit.2023.101176.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 presented to hospital with a history of acute onset of right chest and back pain and shortness of breath.A ct was performed with showed a small focus of contrast along the proximal descending thoracic aorta, with mediastinal hematoma and right hemothorax.The patient was transferred to another facility for further evaluation.The patient was hemodynamically stable.A cta of the chest/abdomen/pelvis was performed , which showed a penetrating aortic ulcer (pau) in the distal descending thoracic aorta.This pau was on the anterior surface of the aorta, and closely associated with the mediastinal hematoma and right hemothorax.It was also noted to be in a separate area from the extravasation noticed on the computed tomography pulmonary embolus study.Previously noted periaortic blush and mediastinal collateral veins were no longer noted.The patient was taken to or where a valiant stent graft was implanted and overlapping stent grafts were placed from the left subclavian artery down to the landing zone of normal aorta just above the celiac axis.The procedure was completed without issue.The patient had palpable femoral pulses and the access site as closed with a non mdt closure device.A right chest tube thoracostomy was performed and there was an immediate return of 400 ml of dark blood from the right chest.The patient was taken to icu for recovery.The patient¿s intensive care unit course was unremarkable for the first 48 hours, with an additional 800 ml of chest tube output and normal mean arterial pressure and vital signs.On late evening postoperative day two, the patient noted acute onset bilateral leg weakness.Given the delayed presentation of paraparesis without obvious cause, the patient was taken urgently for a magnetic resonance imaging of the spine to assess for spinal ischemia vs epidural hematoma or other pathology.The magnetic resonance imaging showed an abnormal spinal cord t2 signal predominantly involving the central spinal cord and gray matter, consistent with spinal cord ischemia.The patient underwent urgent placement of a lumbar cerebrospinal drain.The patient noted improvement in symptoms, and the drain was able to be removed 3 days later with no residual neurological effects noted.The patient was subsequently discharged after removal of the drain and chest tube, and after a short period of physical therapy.The patient was doing well at 30-day follow-up and continues to do well on follow-up visits over a year later.

Manufacturer Narrative

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 STENT GRAFT
• 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: 17323838
• MDR Text Key: 319180457
• Report Number: 9612164-2023-03185
• 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: Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/30/2023

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?: No
• Device Operator: Health Professional
• Device Model Number: UNK-CV-SR-VALIANT
• Device Catalogue Number: UNK-CV-SR-VALIANT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/12/2023
• Initial Date FDA Received: 07/14/2023
• Supplement Dates Manufacturer Received: 08/30/2023
• Supplement Dates FDA Received: 08/30/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR
• Patient Sex: Female