MAUDE Adverse Event Report: THORATEC CORP; VENTRICULAR (ASSIST) BYPASS

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

Patient Problems Anemia (1706); Coagulation Disorder (1779); Heart Failure (2206); Cardiogenic Shock (2262)

Event Date 09/28/2020

Event Type  malfunction  

Event Description

History of nonischemic cardiomyopathy (nicm) s/p left ventricular assist device (lvad) now pod#0 s/p ohtx and lvad explant complicated by coagulopathy requiring open chest and post-operative rv dysfunction (total ischemic time 240 minutes) and vasoplegic shock (pre-op entresto and amiodarone).He is being seen for cardiogenic/vasoplegic shock, acute systolic right heart failure, metabolic lactic acidosis, aki, coagulopathy, and acute blood loss anemia.These conditions carry a high risk of causing imminent and/or life-threatening deterioration in the patient's condition and require my personal management in the intensive care unit.

• Type of Device: VENTRICULAR (ASSIST) BYPASS
• Manufacturer (Section D): THORATEC CORP; 6035 stoneridge drive; pleasanton CA 94588
• MDR Report Key: 11332277
• MDR Text Key: 231992930
• Report Number: 11332277
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2020
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/14/2021
• Event Location: Hospital
• Date Report to Manufacturer: 02/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 11315 DA
• Patient Weight: 111