MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE II LVAS; LEFT VENTRICULAR ASSIST DEVICE

Catalog Number 106015

Device Problem Partial Blockage (1065)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 04/01/2018

Event Type  Injury  

Manufacturer Narrative

Unique identifier (udi) #: (device identifier) - (b)(4).(b)(4) approximate age of device ¿ 4 years and 8 months.  additional information was requested, but was not provided.A supplemental report will be submitted when the manufacturer's investigation is completed.

Event Description

The patient was implanted with a left ventricular assist device (lvad) on (b)(6) 2014.It was reported that low flow alarms had occurred with possible inflow or outflow obstruction.The patient had been admitted to intensive care unit (icu) and placed on multiple infusions and vasopressors.On (b)(6) 2018, it was reported that the patient was too unstable to do any further investigation of the outflow and inflow.The patient¿s atrioventricular (av) did close on (b)(6) 2018.Additional information was requested, but was not provided.

Manufacturer Narrative

The evaluation of the submitted system controller log file confirmed the report of low flow alarms; however, a specific cause could not be conclusively determined through this evaluation.A review of the device history records revealed no deviations from manufacturing or quality assurance specifications.No further information was provided.The manufacturer is closing the file on this event.

Event Description

Additional information: it was reported that there were no further tests performed and the low flows improved on own without known reason.

• Brand Name: HEARTMATE II LVAS
• Type of Device: LEFT VENTRICULAR ASSIST DEVICE
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• MDR Report Key: 7465586
• MDR Text Key: 106651758
• Report Number: 2916596-2018-01511
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 06/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/30/2017
• Device Catalogue Number: 106015
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/18/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 58 YR
• Patient Weight: 87