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

Model Number VEMC4640C200CE

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

Patient Problems Aneurysm (1708); Hematoma (1884); Hemothorax (1896); Ischemia (1942); Necrosis (1971); Pain (1994)

Event Date 09/02/2021

Event Type  Death  

Event Description

A valiant evo was implanted during an unknown endovascular procedure.It was reported on the 60 month follow-up the patient returned for a ct where an enlargement of the aorta distal to the thoracic stent graft at a size of 52.6 mm was observed.3 months later it was reported that the patient presented to the hospital with sudden thoracic pain.Angio ct showed left hemothorax with suspected intramural hematoma (ihm) of thoracic aorta and enlargement of the t-a distal to the stent graft.Intervention was performed where a non-medtronic stent graft was implanted.A second intervention was carried out where additional non-medtronic stents were implanted.An explorative laparoscopy was performed and complete intestinal ischemia and total gangrene of the bowel were observed.The patient expired on the same date.The site assessed the event as not related to the procedure or study device.The sponsor assessed the event as not related to outside soc cip procedure, not related to the implant procedure but possibly related to the valiant evo stent graft system.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: VALIANT EVO - CLINICAL
• 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: 13024671
• MDR Text Key: 282383165
• Report Number: 9612164-2021-04914
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P100040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/17/2021

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/10/2017
• Device Model Number: VEMC4640C200CE
• Device Catalogue Number: VEMC4640C200CE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/10/2021
• Initial Date FDA Received: 12/17/2021
• Date Device Manufactured: 02/11/2016
• 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): Hospitalization; Required Intervention; Death
• Patient Age: 74 YR
• Patient Sex: Male