MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE II LVAS IMPLANT KIT (WITH SEALED GRAFTS); VENTRICULAR (ASSISST) BYPASS

Model Number 106015

Device Problems Decreased Pump Speed (1500); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Death (1802); Hemolysis (1886); Respiratory Distress (2045); Shock (2072)

Event Date 08/01/2020

Event Type  Death  

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 there was concern for hemolysis.The patient's lactate dehydrogenase (ldh) was 900s u/l, with a baseline of 300-400 u/l.Patient was placed on heparin infusion and nabicarb.Inr was therapeutic.Patient went into acute respiratory distress/shock, intubated and family withdrew care and patient expired on (b)(6) 2020.

Manufacturer Narrative

Additional information.Manufacturer¿s investigation conclusion.Although the evaluation of the submitted system controller log file identified a low speed advisory event, a specific cause for this finding, the reported patient outcome associated with acute respiratory distress/shock, and the report of possible hemolysis, could not be conclusively determined through this evaluation.In addition, a direct correlation between heartmate ii left ventricular assist system (lvas), serial number (b)(6), and the reported events could not be conclusively established.The submitted log file captured one transient low speed advisory event on (b)(6) 2020 at 21:56:18, associated with the pump speed decreasing to 8000 rpm, below the low speed limit of 8600 rpm.This event occurred while the system controller was connected to a mobile power unit.The pump appeared to have ramped up to the fixed speed of 9000 rpm following this event without issue.Outside of the single low speed advisory event, the pump appeared to have functioned as intended above the low speed limit throughout the duration of the log file.The relevant sections of the device history records for (b)(6) were reviewed and showed no deviations from manufacturing or quality assurance specifications.The implant kit was shipped on (b)(6) 2013 via customer order (b)(6).The heartmate ii lvas ifu lists respiratory failure, hemolysis, and death as adverse events that may be associated with the use of the heartmate ii left ventricular assist system.Section 6 entitled ¿patient care and management¿ provides information regarding anticoagulation therapy and the recommended inr range.Section 1 entitled ¿introduction¿ outlines all pump parameters, including power, flow, speed, and pulsatility index (pi).Section 7 entitled ¿alarms and troubleshooting¿ outlines all system controller alarms, including the low speed advisory alarm, and provides information regarding how to respond to and troubleshoot the alarms.Heartmate ii lvas patient handbook entitled ¿alarms and troubleshooting¿ outlines all system controller alarms, including the low speed advisory alarm, and provides information regarding how to respond to and troubleshoot the alarms.This handbook cautions the patient to call their hospital contacts if they think, for any reason, any portion of their equipment is not functioning as usual, is broken, or they are uncomfortable with the operation of the equipment.No further information was provided.The manufacturer is closing the file on this event.

Manufacturer Narrative

(device code): correction.No further information was provided.The manufacturer is closing the file on this event.

Event Description

It was reported that there was speed drop below the low speed limit (lsl) to 8000 rpm.It was noted that this speed drop was possibly related to ingestion due to presence of elevated lactate dehydrogenase (hemolysis biomarker).

• Brand Name: HEARTMATE II LVAS IMPLANT KIT (WITH SEALED GRAFTS)
• Type of Device: VENTRICULAR (ASSISST) BYPASS
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• MDR Report Key: 10430448
• MDR Text Key: 203643264
• Report Number: 2916596-2020-04030
• 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: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 11/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/31/2016
• Device Model Number: 106015
• Device Catalogue Number: 106015
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 78 YR
• Patient Weight: 54