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

Catalog Number 106015

Device Problem Partial Blockage (1065)

Patient Problems Hemolysis (1886); Thrombus (2101)

Event Date 02/15/2018

Event Type  Injury  

Manufacturer Narrative

The initial submission of this event was reported by the manufacturer under mfr report # 2916596-2018-01412.This report is being submitted as additional information.Approximate age of device ¿ 5 months.Manufacturer's investigation conclusion: the report of suspected thrombus could not be confirmed.It was reported that the patient presented with elevated ldh and a pump exchange was performed.A thrombus was noted in the inlet and outlet stators and despite multiple requests for product return, the pump has not been received to date.Device thrombosis and hemolysis are listed as adverse events that may be associated with the use of heartmate ii left ventricular assist system and information regarding how to monitor and respond to such events can be found in the heartmate ii instruction for use.A review of the device history records revealed the device met applicable specifications.No further information is available.The manufacturer is closing the file on this event.

Event Description

The patient was implanted with a left ventricular assist device (lvad) on (b)(6) 2017.It was reported that the patient presented with elevated lactate dehydrogenase (ldh) and was admitted into the hospital on (b)(6) 2018, and was given tissue plasminogen activator without a resolution of the hemolysis.The patient was administered iv heparin; however, their ldh continued to rise over 1400 u/l.The patient was asymptotic.A ramp echocardiogram showed the pump was not functioning properly and the left ventricle was decompressing.On (b)(6) 2018, the patient¿s ldh was over 1800 u/l, and subsequently their pump was exchanged.Only the pump body was exchanged.The explanted pump was examined at the hospital and a thrombus was visualized at the inflow conduit and outflow graft.The patient¿s pump parameters were observed to be normal after the original pump was exchanged.

• 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
• Manufacturer (Section G): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 95488
• Manufacturer Contact: bob fryc ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528204
• MDR Report Key: 8131797
• MDR Text Key: 129382834
• Report Number: 2916596-2018-05404
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024011224
• UDI-Public: 00813024011224
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P060040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2020
• Device Catalogue Number: 106015
• Device Lot Number: 6109652
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/15/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/16/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 31 YR
• Patient Weight: 73