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

Model Number 106015

Device Problem Partial Blockage (1065)

Patient Problem Thrombus (2101)

Event Date 06/09/2018

Event Type  Injury  

Manufacturer Narrative

The referenced suspicion of past thrombus issues was reported on medwatch mfr report number 2916596-2017-02502.Approximate age of device ¿ 3 years and 5 months.  the device was returned for investigation.The evaluation is not yet complete.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) 2015.It was reported that the patient received a heart transplant on (b)(6) 2018.The pump was to be returned due to suspicion of past thrombus issues.No additional information was provided.

Manufacturer Narrative

Device evaluation: a correlation between the device and the suspected thrombus could not be conclusively determined through this evaluation.The evaluation of returned pump did not reveal any device related issues.The pump was returned assembled with the driveline severed approximately 11 inches from the pump housing and the distal portion was not returned.The sealed inflow conduit (inlet tube, flex section, and inlet elbow) and the sealed outflow cannula were returned attached to their respective pump ports.Upon disassembly, visual inspection of the pump blood-contacting surfaces revealed no evidence of adhered depositions or thrombus formations.Examination of the pump bearings, rotor, and blood-contacting surfaces under a microscope did not reveal any anomalies related to wear or damage.Electrical continuity testing of the returned portion of the driveline did not reveal any discontinuities or shorts.Functional testing of the pump under normal operating conditions revealed normal pump power consumption and pressure values comparable to the data recorded during the manufacturing process.The pump operated as intended.Device thrombosis and hemolysis are listed in the instructions for use as potential adverse events that may be associated with the use of the heartmate ii left ventricular assist system.A review of the device history records revealed 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: 7657440
• MDR Text Key: 112989491
• Report Number: 2916596-2018-02408
• 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: 09/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/31/2017
• Device Model Number: 106015
• Device Catalogue Number: 106015
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/30/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 62 YR
• Patient Weight: 71