MAUDE Adverse Event Report: THORATEC CORPORATION HEART MATE II LVAS, EUROPE; LEFT VENTRICULAR ASSIST DEVICE

Catalog Number 104912

Device Problems Partial Blockage (1065); Device Stops Intermittently (1599)

Patient Problem Thrombus (2101)

Event Date 04/22/2018

Event Type  Injury  

Manufacturer Narrative

The patient¿s age was not provided.Unique identifier (udi) # (device identifier): device was manufactured prior to the udi labeling implementation.Approximate age of device ¿ 3 years and 5 months.The patient remains ongoing on lvad support await a heart transplant.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.It was reported that a pump stoppage occurred on (b)(6) 2018.It was not possible to restart the pump; therefore, the patient was admitted to the intensive care unit.A contrast ct scan revealed a bit of back flow in addition to a partly occluded outflow graft.The system controller log file reviewed by the manufacturer¿s technical service representative noted multiple intermittent pump stoppages and pump speeds below the low speed limit that occurred while on power module and battery power.The patient is hemodynamically stable and no further issues have been reported.The patient has been listed for transplant.No additional information was provided.

Manufacturer Narrative

Although the reported low speed and pump stoppage events were confirmed by the submitted system controller log file, the cause could not be conclusively determined without a device 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: HEART MATE II LVAS, 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: 7511703
• MDR Text Key: 108176188
• Report Number: 2916596-2018-01742
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Reporter Country Code: BO
• 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,Followup
• Report Date: 06/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/31/2014
• Device Catalogue Number: 104912
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/23/2018
• Initial Date FDA Received: 05/14/2018
• Supplement Dates Manufacturer Received: 06/07/2018
• Supplement Dates FDA Received: 06/27/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/28/2012
• 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 Weight: 102