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

Catalog Number 106015

Device Problem Partial Blockage (1065)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/24/2017

Event Type  Injury  

Manufacturer Narrative

Device unique identifier(udi)-device was manufactured prior to the udi labeling implementation.Approximate age of device-3 year and 10 months.The patient remains on lvad support with no further issues reported.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) 2014.On (b)(6) 2017, it was reported that the patient¿s lvad system had been indicating low flow/red heart alarms for approximately 12 hours.The patient remained asymptomatic.Oral and intravenous fluids were being administered to the patient.An echocardiogram ramp study performed was reportedly within normal limits.The system controller log file submitted to the manufacturer¿s technical services for analysis confirmed the reported low flow alarms.On (b)(6) 2017, it was reported that the low flow alarms continued to be persisted without signs of decompensation or fluid overload.An echocardiogram revealed that the aortic valve remained open with increments in the pump speed.The pump speed was adjusted to 9800 rpms with less occurrence of low flow alarms.The patient¿s inr was 3.3 and on intravenous heparin.There were no signs of hemolysis.A ct scan of the chest demonstrated narrowing of the outflow graft at the anastomosis site.Intervention with stenting of the outflow graft was performed via endovascular approach.After the outflow graft stenting procedure was performed, subsequent system controller log files showed that the pump parameters returned to patient¿s baseline values.No additional information was provided.

Manufacturer Narrative

Although the evaluation of the submitted system controller log files confirmed the report of low flow alarms, a specific cause for the events could not be conclusively determined through this evaluation.A review of the device history records revealed no deviations from manufacturing or quality assurance 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: 7134739
• MDR Text Key: 95377896
• Report Number: 2916596-2017-03284
• 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,Followup
• Report Date: 05/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2016
• 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: 04/29/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/11/2013
• 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: 73 YR
• Patient Weight: 76