MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM; VENTRICULAR (ASSISST) BYPASS

Model Number 106524INT

Device Problem Device Alarm System (1012)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 09/12/2019

Event Type  Injury  

Manufacturer Narrative

No further information was provided.A supplemental report will be submitted when the manufacturer's investigation is completed.

Event Description

It was reported that the patient underwent heart transplant.The patient was on urgent transplant list due to recurrent alarms on controller.No further information was provided.

Manufacturer Narrative

Manufacturer investigation conclusion: the evaluation of heartmate 3 lvas, serial number (b)(6), revealed areas of corrosion within the pump cable in-line connector.In addition, areas of corrosion were also observed within the modular cable in-line connector.A specific cause for these findings could not be conclusively determined through this evaluation.The observed corrosion could have contributed to the report of driveline power fault alarms, that were confirmed through previous submitted log files, as well as through the retrieved log files during testing.Furthermore, the previous report of difficulty disconnecting the modular cable and pump cable could have been contributed to these findings as well.Lastly, following a thorough cleaning of the in-line connectors, no further driveline power fault alarms were observed.The pump was returned assembled with the pump cable severed approximately 2¿ from the pump housing.A middle segment was returned measuring approximately 10¿.The distal portion of the pump cable was also returned attached to the modular cable via the in-line connector.The sealed outflow graft was returned attached to the pump outflow with the sealed outflow graft bend relief properly engaged to the graft attachment.The apical cuff was returned secured with the cuff lock fully engaged.Visual inspection of the blood-contacting surfaces of the returned device revealed no evidence of depositions or thrombus formations that would have contributed to a functional or flow issue.Visual inspection of the pump rotor and rotor well did not reveal any surface scratches or defects.The pump was cleaned and reassembled.The lvad event and periodic log files downloaded from the returned pump appeared to show the lvad operating as intended with stable pump parameters captured prior to the transplant procedure.Upon disconnecting the pump cable and module cable, it was noted that significant force was required.Upon disconnection, green corrosion was noted within the in-line connectors of both the modular cable and pump cable.The origins of the corrosion could not be determined.The o-rings within the in-line connector of the modular cable were observed to be intact and free from damage.Continuity testing of the modular cable revealed an intermittent open connection on the power b line.Continuity testing of the pump cable segments revealed an intermittent open connection on the power b line on the distal portion of the pump cable.The remaining wires were unremarkable.The returned hm3 pump, serial number, (b)(6) was placed on a mock circulatory loop with the returned modular cable, lot number 202058, using a test system controller, patient cable, power module, system monitor and water loop.Driveline power fault alarms were observed on the system controller and system monitor.The returned components were then tested separately on the mock circulatory loop using the laboratory test equipment.Power fault alarms were also observed.Following the mock circulatory loop tests, both the in-line connectors were thoroughly cleaned.A repeat continuity testing was performed.All wires passed and no discontinuities or wire-to-wire shorts were induced, even with manipulation of the cables.The returned pump was then placed on the mock circulatory loop with the returned modular cable.No driveline power fault alarms were observed on the system controller and system monitor, even with manipulation of the cables.The pump and modular cable appeared to function as intended.Therefore, the observed corrosion in the in-line connectors may have contributed to the driveline power fault alarms.However, a specific cause for the corrosion cannot be determined.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM
• Type of Device: VENTRICULAR (ASSISST) BYPASS
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 95488
• MDR Report Key: 9136825
• MDR Text Key: 160766680
• Report Number: 2916596-2019-04558
• 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: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 02/25/2020

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: Health Professional
• Device Expiration Date: 10/31/2020
• Device Model Number: 106524INT
• Device Catalogue Number: 106524INT
• Device Lot Number: 6257942
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/13/2019
• Initial Date FDA Received: 09/30/2019
• Supplement Dates Manufacturer Received: 01/30/2020
• Supplement Dates FDA Received: 02/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention