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 Disseminated Intravascular Coagulation (DIC) (1813); Hematoma (1884); Hemorrhage/Bleeding (1888); Hematuria (2558); Pseudoaneurysm (2605); Thrombocytopenia (4431); Epistaxis (4458)

Event Date 08/28/2021

Event Type  Injury  

Event Description

Valiant stent grafts were implanted in patients during the endovascular treatment of thoracoabdominal aneurysm repair on unknown dates.The following adverse events were reported: thrombocytopenia, disseminated intravascular coagulation (dic), bleeding (gastrointestinal hemorrhage, petechial hemorrhage) hematoma(retroperitoneal hematoma, & mesenteric hematoma), hemorrhagic cystitis, anastomotic pseudoaneurysm, epistaxis, intervention.The cause of the adverse events are undetermined.

Manufacturer Narrative

Medtronic received the following information from a journal article entitled; extensive aortic stent graft coverage for thoracoabdominal aortic aneurysm is associated with hemorrhagic complications induced by disseminated intravascular coagulation kawashima et al, ann vasc surg 2022; 78: 152¿160 https://doi.Org/10.1016/j.Avsg.2021.06.017.Exact date of implant unknown.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: 13341479
• MDR Text Key: 284347856
• Report Number: 9612164-2022-00321
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P100040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/25/2022

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?: 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: 01/17/2022
• Initial Date FDA Received: 01/25/2022
• 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: 61 YR
• Patient Sex: Male