MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE II LVAS; LVAD

Device Problem Cut In Material (2454)

Patient Problems Cardiac Arrest (1762); Death (1802)

Event Date 09/26/2013

Event Type  Death  

Event Description

Patient presented to ed in cardiac arrest.Patient was found with lvad driveline cut.Patient coded and acls was followed, however, patient expired on (b)(6) 2013.

• Brand Name: HEARTMATE II LVAS
• Type of Device: LVAD
• Manufacturer (Section D): THORATEC CORPORATION; pleasanton CA
• MDR Report Key: 3635599
• MDR Text Key: 4181911
• Report Number: 3635599
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Source Type: Invalid Data
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/19/2014,02/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Other Device ID Number: VAD-53363
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/19/2014
• Distributor Facility Aware Date: 10/10/2013
• Date Report to Manufacturer: 02/21/2014
• Patient Sequence Number: 1
• Patient Outcome(s): Death