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

Model Number 105306

Device Problems Break (1069); Restricted Flow rate (1248); Pumping Stopped (1503)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/24/2019

Event Type  malfunction  

Manufacturer Narrative

Previously mentioned percutaneous lead replacement was reported under (b)(4).Approximate age of device- 5 years, 3 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) 2013.It was reported the patient had low flow, low voltage and pump off alarms.Technical services reviewed the submitted log files, and pump stoppages and pump decelerations were confirmed.This behavior is indicative of potential issues with the percutaneous lead (driveline).The issues appeared to be occurring on both the power module and on batteries.Submitted x-rays were unremarkable.It was reported the patient was transferred to the intensive care unit.Technical services already performed a distal end percutaneous lead replacement on (b)(6) 2018 ((b)(4)).The manufacturer's investigation of the driveline at that time did not reveal any areas of compromised wire insulation that would have contributed to the reported events.Following the replacement, no additional pump stoppages were reported and the issue seemed to have been resolved.Additional information received 01/29/2019 reported that the patient remains inpatient, is stable and being monitored.There have been no additional lvad alarms or pump stoppages.The continued plan of care is for the patient to continue with ungrounded cable.No pump exchange is planned for this time.No additional information was provided.

Event Description

Additional information was reported on 28feb2019 that the patient underwent a pump exchange on (b)(6) 2019.The patient tolerated the procedure well.The pump was given to pathology; it will return, but it is unknown when.No additional information was provided.

Manufacturer Narrative

Manufacturer's investigation: the evaluation of heartmate ii lvas, serial number (b)(4), confirmed a driveline issue that could have contributed to the report of pump stops, which were observed in the submitted log file.The submitted system controller log file captured several pump stops and low speed hazard/advisory alarms on (b)(6) 2019 starting at 01:11:43 am.These events occurred while the system controller was connected to both battery power and the power module.Low flow hazard alarms were also observed during these events, which were associated with the low speed hazard events.Based on previous complaint history, these events could be indicative of a potential driveline issue.It was reported that the patient underwent a pump exchange on (b)(6) 2019.(b)(4) was returned assembled with the driveline severed approximately 3.5¿ from the pump housing.The distal end of the driveline was returned measuring approximately 30¿, and the remainder of the driveline was not returned.The prior driveline repair site was observed approximately 19¿ through 23¿ from the metal connector.Metal braided shield breakdown was observed approximately 28.5¿ from the metal connector.Examination through the metal braided shield breakdown revealed breaches in the insulation of the orange, yellow, green, and black wires approximately 28¿ through 29¿ from the metal connector, exposing the inner conductors.The insulation damage appeared consistent with fatigue failure due to repetitive flexing and abrasion against the metal braided shield.If the exposed inner conductors of any two wires from different phases made direct contact with each other or simultaneous contact with the metal braided shield, the resulting phase-to-phase short could have resulted in the pump stops and low speed observed in the log file while connected to either battery power or the power module.In addition, if the exposed inner conductors of any of the wires made contact with the metal braided shield while connected to a tethered power source, the resulting electrical short to ground could have resulted in the pump stops and low speed events observed in the log file while connected to the power module.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE
• Type of Device: LEFT VENTRICULAR ASSIST DEVICE
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 95488
• MDR Report Key: 8313425
• MDR Text Key: 135563250
• Report Number: 2916596-2019-00455
• 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: health professional,user faci
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/11/2019

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: 10/31/2015
• Device Model Number: 105306
• Device Catalogue Number: 105306
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/24/2019
• Initial Date FDA Received: 02/06/2019
• Supplement Dates Manufacturer Received: 02/28/2019; 02/28/2019; 04/10/2019
• Supplement Dates FDA Received: 02/28/2019; 03/05/2019; 04/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 57 YR
• Patient Weight: 126