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

Catalog Number 106015

Device Problem Partial Blockage (1065)

Patient Problem Thrombus (2101)

Event Date 12/21/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Approximate age of device - 2 months.The patient remains on an extracorporeal circulatory support pump.No additional 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.It was reported that the patient was being evaluated for heart transplant, and the clinicians observed several left ventricular suction events.A ramp study performed was negative and a computed tomography of the chest area did not suggest a malposition of the lvad.The lvad clinician was able to decompress the ventricle at higher speeds.Due to suspicion of thrombus, rather than worsening rv failure, the lvad pump was explanted.The date of explant was not reported.On explant, the surgeons noted a thrombus in the inflow cannula.No additional information was provided.

Manufacturer Narrative

Analysis of the submitted system controller log files confirmed frequent pi events; however, a direct correlation between the left ventricular assist system (lvas) and the suspected pump thrombosis could not conclusively be established through this evaluation.The submitted log file contains data from 21dec2017 at 11:44:41 through 22dec2017 at 08:04:16.236 total pi events were captured through the duration of the file.The pump speed remained above the low speed limit and no atypical alarms were captured for the duration of the file.No notable trends in pump parameters were observed and the system appeared to be operating as intended.Thrombus is 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
• 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: 7204206
• MDR Text Key: 97720181
• Report Number: 2916596-2018-00252
• 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
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 03/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 12/31/2018
• 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: 02/28/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/03/2016
• 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: 61 YR
• Patient Weight: 91