MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM, EUROPE; LEFT VENTRICULAR ASSIST DEVICE

Catalog Number 106524INT

Device Problems Partial Blockage (1065); Material Twisted/Bent (2981)

Patient Problem Thrombus (2101)

Event Date 03/18/2018

Event Type  Injury  

Manufacturer Narrative

The patent's age, gender and weight were not provided.Fda approval for heartmate 3 lvas was received on 23 august 2017.The gtin unique device identifier for the commercial heartmate3 lvas is (b)(4).Approximate age of device ¿ 1 year and 3 months.The device was returned for investigation.The evaluation is not yet complete.The patient remains ongoing on lvad support with the replacement device.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) 2016.It was reported that low flow alarms occurred.The patient¿s inr was 2.6 upon admission to the hospital, and was not under 2.0 the last three months.The patient¿s plasma free hemoglobin and lactate dehydrogenase levels were normal.There were no signs of infection.A chest ct scan showed an obstruction on the outflow graft.A pump exchange was performed on (b)(6) 2018 due to suspected pump thrombosis and possible outflow graft twisting.No additional information was provided.

• Brand Name: HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM, EUROPE
• 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: 7424678
• MDR Text Key: 105252494
• Report Number: 2916596-2018-01316
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Reporter Country Code: DA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 04/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2019
• Device Catalogue Number: 106524INT
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/18/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/05/2016
• 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