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

Catalog Number 106015

Device Problems Partial Blockage (1065); Infusion or Flow Problem (2964)

Patient Problem Thrombus (2101)

Event Date 04/23/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Approximate age of device - 2 years and 4 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.The manufacturer¿s technical services representative reviewed the submitted log file and observed transient power elevations.There was not enough evidence to say this was thrombus.There were no other unusual events seen within the log file.The lvad clinician reported that the patient¿s lactate dehydrogenase (ldh) levels were elevated and the patient¿s urine was dark.Technical services advised to look at other clinical indications that may confirm the presence of thrombus.On (b)(6) 2018, it was reported the patient had a pump exchanged due to elevated ldh 1163 u/l and admitting inr at 1.7.The patient was started on heparin drop and their creatinine was 2.16.The pump will be returned for evaluation.Additional information was requested, but not provided.

Manufacturer Narrative

Correction: change no to yes.The evaluation of the returned left ventricular assist system (lvas) confirmed the presence of pump thrombosis, which could have contributed to the reported increase in the reported lactate dehydrogenase (ldh) level.The pump was returned assembled with the driveline severed approximately 3.75 inches from the pump housing and the distal portion of the driveline measuring approximately 37 inches was also returned.The sealed inflow conduit (inlet tube, flex section, and inlet elbow), sealed outflow graft, and outflow graft bend relief were not returned.The outflow elbow was returned attached to the pump¿s outlet port.Upon disassembly of the pump, examination of the rotor inlet section revealed a ring of red, tissue-like deposition surrounding the inlet bearing cup on distal side of the inlet stator.The laminated structure of the thrombus formation and its areas of denaturation indicate that it likely formed over an indeterminate period of time while the pump was supporting the patient.Although a specific cause for its development and a duration of time for which it was present within the pump could not be conclusively determined, the thrombus formation could have potentially contributed to the reported increase in the patient¿s lactate dehydrogenase level.Upon removal of the observed deposition, the device was cleaned.The disassembled pump¿s bearings, rotor, and blood-contacting surfaces were examined under a microscope and no anomalies were observed.Electrical continuity testing of the driveline did not reveal any discontinuities or shorts.The pump was reassembled and functionally tested under normal operating conditions using a mock circulatory loop.The data retrieved from that testing revealed normal pump power consumption and pressure values, comparable to what was recorded during the manufacturing process and the device functioned as intended.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 LVAS
• Type of Device: LEFT VENTRICULAR ASSIST DEVICE
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• MDR Report Key: 7524736
• MDR Text Key: 108605446
• Report Number: 2916596-2018-01759
• 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: 06/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/31/2018
• Device Catalogue Number: 106015
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/25/2018
• Date Manufacturer Received: 05/24/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention