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

Catalog Number 107801

Device Problem Partial Blockage (1065)

Patient Problems Dyspnea (1816); Fatigue (1849); Thrombus (2101)

Event Date 01/06/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Approximate age of device ¿ 7 months.(b)(4).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.It was reported that the patient called the implanting center indicating that the pump sounded loud.The patient went to the implanting center and reported that his urine was dark, he was feeling more fatigued, and he was more short of breath.The patient's lactate dehydrogenase (ldh) levels had fluctuated between 600 u/l and 1000 u/l.The patient was admitted and integrilin gtt was attempted without success.There were no changes in vad parameters and the patient was fully anticoagulated on coumadin, a full dose asa and 150mg of persantine three times a day.A ramp echocardiogram was completed, which showed left ventricle decompressing, but not as much as it had in the past and his aortic valve was opening with every beat in spite of the speed increase, where as in the past it had been closed.A ct angiogram was completed which, showed no occlusion in the outflow graft.The patient underwent a pump exchange on (b)(6) 2018 due to suspected thrombus.After the pump was removed, the surgeon did observed a small thrombus in the pump.No further information was provided.

Manufacturer Narrative

The report of suspected thrombus was confirmed during the evaluation of the left ventricular assist system (lvas).Examination of the pump blood-contacting surfaces found a denatured red tissue-like thrombus on the proximal end of the rotor.The sample was sent for histology and was found to be fibrin clots admixed with serum proteins and red blood cell breakdown with no evidence of any organism.The age of the clot was over 5 days.An additional flat thrombus formation was found on the center of the blood tube.The dark area of denaturation on the thrombus indicates that it was present while the pump was supporting the patient.The non-laminated structure of the thrombus formation suggests that it did not originate on the rotor and initially developed in another location; however, its specific origin could not be conclusively determined.Another thrombus was found between blades of the outlet stator, showing similar color and texture to the thrombi found on the rotor.The observed thrombi could have contributed to the reported increase in lactate dehydrogenase (ldh).The evaluation could not determine the origins of the thrombi.Upon removal of the observed deposition, the device was cleaned.The pump's bearings, rotor, and blood-contacting surfaces were then examined under a microscope and no anomalies were observed.Electrical continuity testing of the driveline revealed no 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: 7232448
• MDR Text Key: 98732807
• Report Number: 2916596-2018-00394
• 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: 06/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 03/31/2020
• Device Catalogue Number: 107801
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2018
• Initial Date Manufacturer Received: 01/11/2018
• Initial Date FDA Received: 01/31/2018
• Supplement Dates Manufacturer Received: 05/30/2018
• Supplement Dates FDA Received: 06/25/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 50 YR
• Patient Weight: 69