MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM, NA

Model Number 106015

Device Problem Partial Blockage (1065)

Patient Problems Thrombus (2101); Test Result (2695)

Event Date 06/08/2018

Event Type  Injury  

Manufacturer Narrative

Approximate age of device- 4 years and 1 month.The device is expected to be returned for evaluation.It has not yet been received.No further information was 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 the patient the patient had a suspected pump thrombus and presented with an elevated lactate dehydrogenase (ldh) in the 1000's u/l.The patient was taken back to the operating room for a pump exchange and found to have great recover; therefore, was explanted instead.The pump will be returned for evaluation.The patient is reported to be doing well and out of the intensive care unit (icu).No additional information was provided.

Manufacturer Narrative

The pump was not returned therefore not available for evaluation.A correlation between the device and the suspected thrombus and reported hemolysis could not be conclusively determined.The account communicated that the patient had a suspected pump thrombus with ldh in the 1000s.The patient was taken back to the operating room on (b)(6) 2018 for an exchange; however, the pump was explanted as the patient was found to have a great recovery.The patient remains without support and was reportedly doing well out of the icu.Although it was noted that the pump would be returned for evaluation, it was later communicated that pump was being retained in the pathology department pending a patient signature.Thrombus and hemolysis are listed in the instructions for use as a potential adverse event that may be associated with the use of the heartmate ii left ventricular assist system.A review of the device history records revealed that the device met applicable specifications.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM, NA
• Type of Device: LEFT VENTRICULAR ASSIST SYSTEM
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 95488
• MDR Report Key: 7650304
• MDR Text Key: 112723558
• Report Number: 2916596-2018-02546
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024011224
• UDI-Public: 00813024011224
• Combination Product (y/n): N
• PMA/PMN Number: P060040
• 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: 12/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/16/2016
• Device Model Number: 106015
• Device Catalogue Number: 106015
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/29/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 68 YR
• Patient Weight: 96