MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM, NA

Model Number 106015

Device Problems Loose or Intermittent Connection (1371); Obstruction of Flow (2423); Communication or Transmission Problem (2896)

Patient Problems Thrombus (2101); No Known Impact Or Consequence To Patient (2692)

Event Date 03/04/2019

Event Type  Injury  

Manufacturer Narrative

Approximate age of device - 1 year 7 months.The patient remains ongoing with the 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) 2017.It was reported that a request for analysis was received by (b)(6) on (b)(6) 2019.Technical services stated that there were elevated powers and flows throughout the log file.There was also a driveline disconnect on (b)(6) 2019 at 11:27.

Manufacturer Narrative

Adverse event and outcomes attributed to adverse events: corrected data.

Manufacturer Narrative

Manufacturers investigation conclusion: evaluation of the submitted log file confirmed elevations in power up to 16.7 watts between (b)(6) 2019 and (b)(6) 2019 corresponding to elevations in flow to 12 liters per minute (lpm).A specific cause could not be conclusively determined through this evaluation.A driveline disconnect was captured on (b)(6) 2019 at 11:27am resulting in a pump stop and alarms for low speed and low flow hazard as well as motor stop.A correlation between the device and reported pump thrombus could not be determined.The device was not returned for evaluation.No further information was provided.The hmii ifu lists device thrombosis as an adverse event that may be associated with the use of the hmii lvas.The ifu addresses indications of device thrombosis and how to respond to such events, as well as recommended anticoagulation therapy and inr range with the use of the hmii lvas.The ifu warns against disconnection of the driveline as it would result in pump stop.No further information was provided.The manufacturer is closing the file on this event.

Event Description

Event was initially reported as elevated pump powers, which can be a symptom of device thrombus.Patient had a heartmate ii exchange on (b)(6) 2019 due to pump thrombosis.

• Brand Name: HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM, NA
• Type of Device: LEFT VENTRICULAR ASSIST SYSTEM
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 95488
• MDR Report Key: 8448631
• MDR Text Key: 139726826
• Report Number: 2916596-2019-01326
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024011224
• UDI-Public: 00813024011224
• Combination Product (y/n): N
• PMA/PMN Number: P060040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/31/2020
• Device Model Number: 106015
• Device Catalogue Number: 106015
• Device Lot Number: 6042301
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 56 YR
• Patient Weight: 194