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 Problem Hemolysis (1886)

Event Date 01/05/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Approximate age of device ¿ 2 months.The patient remains ongoing with lvad support.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) 2017.On (b)(6) 2018, it was reported that the patient had a rapid increase in lactate dehydrogenase to 800 u/l with concern for pump thrombosis.On (b)(6) 2018, the patient¿s inr was 4.1.No clinical symptoms were reported.A log file was submitted for review.The manufacturer¿s technical services reviewed the provided log file which contained data from (b)(6) 2018 and observed some unsustained power and flow elevations.No other unusual events were seen within the event history and the pump appeared to be functioning as intended.Additional information was requested but not yet 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: 7285745
• MDR Text Key: 100558742
• Report Number: 2916596-2018-00644
• 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: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 02/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/31/2020
• Device Catalogue Number: 106015
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/24/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/05/2017
• 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
• Patient Age: 57 YR
• Patient Weight: 126