MAUDE Adverse Event Report: MEDTRONIC, INC. ENDURANT IIS; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Model Number ESBF3214C103E

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Cardiopulmonary Arrest (1765); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 07/28/2020

Event Type  malfunction  

Event Description

Patient brought to operating room emergently for abdominal aortic aneurysm (aaa) repair.Deployed the main body graft.The patient then decompensated requiring cpr and open procedure.The main body graft was explanted.

• Brand Name: ENDURANT IIS
• Type of Device: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): MEDTRONIC, INC.; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 10626499
• MDR Text Key: 209803653
• Report Number: 10626499
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 08/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: ESBF3214C103E
• Device Catalogue Number: ESBF3214C103E
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/17/2020
• Event Location: Hospital
• Date Report to Manufacturer: 10/05/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1