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

Model Number 103695

Device Problem Partial Blockage (1065)

Patient Problem Death (1802)

Event Date 03/07/2014

Event Type  Injury  

Manufacturer Narrative

Device unique identifier (udi) ¿ device was manufactured prior to the udi labeling implementation.Approximate age of device - 4 years, 5 months.Thrombus was confirmed in the evaluation of the returned pump.The pump was returned with the percutaneous lead intact.The inflow conduit was returned attached to the pump inlet port.The outflow graft and the outflow graft bend relief was returned attached to the outflow elbow.The outflow elbow was returned attached to the pump outlet port.The outflow graft conduit was returned with approximately 6¿ of graft material.The outflow graft bend relief was returned, properly attached to the outflow graft attachment.Upon removal of the bend relief, visual inspection of the outflow graft revealed a counter-clockwise twist at the proximal end of the graft.The black line on the graft indicates that graft was twisted approximately 45 degrees.The tissue accumulation on the exterior of the graft appeared to have conformed to the twist, suggesting that the graft had been twisted for an undetermined period of time while the pump was supporting the patient.The lumen of the outflow graft revealed a deposition of tissue admixed with clotted blood in the folds of the graft twist.Although a specific cause for the observed twist in the outflow graft could not be conclusively determined through this evaluation, it could have also contributed to the reported low flow alarms.Upon disassembly of the returned pump, examination of the proximal and distal sides of the inlet stator revealed a large tissue-like deposition.Similar depositions were also noted surrounding the inlet bearing ball, on the body of the rotor, and in the outlet stator.The lack of structure of the depositions and the lack of laminated layering suggests that the depositions did not form in these areas and that they were likely ingested at some point during pump support.Although the origins and duration of time for which the depositions were present in the pump cannot be conclusively determined, there were circumferential contact marks on the outlet bearing cup and outlet cone section of the rotor which indicate that at least the deposition found in the outlet stator was present in the device for an extended amount of time while it was in operation.The depositions appeared to have occluded a majority of the blood pathway and could have potentially contributed the reported low flow alarms.Examination of the pump bearings, rotor, and blood-contacting surfaces under a microscope revealed no abnormalities that would have contributed to the formation of the depositions.The pump underwent cleaning, reassembly, and functional testing under loaded conditions using a mock circulatory loop.The retrieved data revealed normal pump power consumption comparable to the pump power consumption recorded during the manufacturing process.The pump operated as intended.A review of the device history records revealed the device met applicable specifications.No further information was provided.The manufacturer is closing the file on this event.

Event Description

The patient was implanted with a left ventricular assist device (lvad) on (b)(6) 2009.It was reported by the vad coordinator that the patient expired due to cardiac arrest, the patient did not expire due to the pump.The lvad system had been consistently producing low flow alarms.The system controller was eventually exchanged.At the time of autopsy it was noted that the outflow graft was "crispy".

Manufacturer Narrative

The initial submission of this event was reported under the manufacturer under mfr.Report # 2916596-2014-00498.This report (2916596-2018-03343) was submitted as additional information.The manufacturer has closed the file on this event.

• 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: 7831179
• MDR Text Key: 118726733
• Report Number: 2916596-2018-03343
• Device Sequence Number: 1
• Product Code: DSQ
• 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
• Report Date: 09/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/31/2012
• Device Model Number: 103695
• Device Catalogue Number: 103695
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2014
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/06/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 52 YR
• Patient Weight: 98