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

Catalog Number 106015

Device Problems Partial Blockage (1065); High Readings (2459)

Patient Problems Hemolysis (1886); Renal Failure (2041); Thrombus (2101)

Event Date 03/28/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Approximate age of device ¿ 1 year.Device evaluation: the explanted pump was returned assembled with the driveline severed approximately 7 inches from the pump housing.The remainder of the driveline was not returned.Ring-like thrombus formations were observed surrounding the inlet bearing cup and bearing ball, partially obstructing the flow of blood.The similarity in structure of these thrombus formations indicate that they likely formed as one thrombus and were pulled apart during disassembly of the pump.The laminated structure of this thrombus and the observed areas of denaturation indicate that it likely formed over an indeterminate duration while the device was supporting the patient.Although a direct cause for the development of the thrombus and a duration for which it was present within the pump could not be conclusively determined, it could have contributed to the reported elevation in ldh.A direct correlation between the device and the reported outflow graft stenosis could not be conclusively determined through this evaluation.The pump bearings, rotor, and blood-contacting surfaces were examined under a microscope and no anomalies related to wear or damage were observed that would have contributed to a functional issue.Electrical continuity testing of the returned portion of the driveline did not reveal any discontinuities or shorts.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.

Event Description

The patient was implanted with a left ventricular assist device (lvad) on (b)(6) 2017.It was reported that the patient was elevated to status 1a on the transplant list secondary to pump thrombosis.The patient had a previously unreported history of elevated lactate dehydrogenase (ldh) and an lvad outflow graft stenosis per ct scan.The spike in ldh started on (b)(6) 2017.On (b)(6) 2017, the patient¿s ldh peaked at 1783 u/l and normalized to range of 375 u/l on (b)(6) 2017.In may, ldh remained chronically elevated in the 500-900 u/l range and peaked to 1144 u/l on (b)(6) 2017.On an unspecified date, the patient was admitted to the hospital due to an elevated ldh and was treated with a heparin infusion.The patient¿s target inr goal was increased from 2-3 to 3-3.5.In addition 75 mg tid of diypyridamole was added.Upon admission for transplant on an unspecified date, the patient had low hemoglobin and hematocrit results and ldh was found to be greater than 1700 u/l.The patient received a heart transplant on (b)(6) 2018.The pump was returned for analysis.No additional information was provided.

• Brand Name: HEARTMATE II LVAS
• Type of Device: LEFT VENTRICULAR ASSIST DEVICE
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• Manufacturer (Section G): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• Manufacturer Contact: bob fryc ; 6101 stoneridge dr.; pleasanton, CA 94588 ; 7818528390
• MDR Report Key: 7298070
• MDR Text Key: 101001631
• Report Number: 2916596-2018-00701
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 02/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/30/2019
• Device Catalogue Number: 106015
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/31/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/20/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 59 YR
• Patient Weight: 115