MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE 3 VAD MODULAR CABLE; LVAD MODULAR CABLE

Model Number 106525

Device Problem No Display/Image (1183)

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

Event Date 04/03/2019

Event Type  Injury  

Manufacturer Narrative

The heartmate 3 lvas was implanted during the momentum 3 clinical trial, ide# (b)(4).Fda approval for heartmate 3 lvas was received on 23 august 2017.The same device is used commercially and in the ongoing momentum 3 trial.The gtin unique device identifier for the commercial heartmate3 lvas is (b)(4).Approximate age of device ¿ 2 years 2 months 14 days.The patient remains ongoing with the lvad 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 left a ventricular assistance device (lvad) on (b)(6) 2017.It was reported that the patient was seen in the emergency department noted power driveline fault alarm.The patient performed a controller switch to his back up controller without resolution of his alarms.He then proceeded to perform another controller switch back to his original primary controller without resolution.The driveline modular cable and system controller were exchanged with noted resolution of alarms.Patient was discharged (b)(6) 2019.Patient called back and stated he was in the car and didn¿t feel well and checked his controller and could not see any of his parameters except for the power.No audible alarms.The pump run symbol was illuminated.They were advised to return to the vad clinic.In the vad clinic, an lvad fault alarm was observed and they were unable to observe the vad parameters except for the power consumption.The file did capture false pump stop indications due to an issue with the pump current sensing feature.(this feature is not vital to pump operation.) this is the source of the lvad fault alarm the patient reported.While the flow value was not available the log file has a per second flow value available.It is graphed below along with pump power and pump speed.There was no interruption in pump support to the patient in this log file.No additional information was reported.

Event Description

It was reported that the patient has been well controlled since restarting lisinopril and increasing coreg, no vad communication issues, vad flows stable, and no hazard alarms overnight.Patient was discharged (b)(6) 2019.No additional information was reported.

Manufacturer Narrative

Manufacturer's investigation conclusion: the returned modular cable was in used condition.Visual inspection revealed that both bend reliefs were discolored and there was one burned pin inside the driveline connector.The returned modular cable was connected to the returned system controllers, a test pump, pm patient cable, power module, and system monitor.The system operated as intended without any alarms active; manipulating the cable had no effect on pump function and did not result in any alarm.The modular cable was functionally tested and passed the test procedure.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: HEARTMATE 3 VAD MODULAR CABLE
• Type of Device: LVAD MODULAR CABLE
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 95488
• MDR Report Key: 8519079
• MDR Text Key: 142096058
• Report Number: 2916596-2019-01825
• 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: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 07/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/01/2019
• Device Model Number: 106525
• Device Catalogue Number: 106525
• Device Lot Number: 171754
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Weight: 95