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

Model Number 106015

Device Problems High Readings (2459); Infusion or Flow Problem (2964); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hemolysis (1886); Thrombus (2101)

Event Date 09/14/2020

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 had lactic acid dehydrogenase (ldh) increased to 920 from 425 on (b)(6) 2020 and plasma free hemoglobin 30 from less 30 on (b)(6) 2020.The patient was not exhibiting signs or symptoms of pump thrombosis.The patient's urine is clear and the patient stated he felt great.No power fluctuations seen on interrogation.All other labs normal.Technical services reviewed the log file, which captured multiple pi events, which were seen in significant amounts indicating a larger issue.There were no other unusual events recorded in the log file event history.The mcs equipment is operating as intended.The patient was admitted on (b)(6) 2020.On (b)(6) 2020 a fast alarm occurred while the patient was on the power module.There were no alarms on the controller history or on the monitor.Technical services reviewed the log file, which continued to capture pi events, but there were no other unusual events.

Manufacturer Narrative

Section b5, h6 (patient code, device code): additional information.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 had been in the hospital since (b)(6) 2020 with suspected pump thrombosis.The patient was currently on multiple antiplatelet and anticoagulation medications in addition to integrilin.The patient was currently listed for transplant.There were some flow elevations over the weekend.The patient's lactate dehydrogenase (ldh) was consistently in the 300s on various therapies.Plasma free hemoglobin transiently went up over the weekend.Technical services reviewed the log file and there were no unusual events recorded in the log file event history.

Event Description

It was reported that the patient was not admitted since (b)(6) 2020.The patient underwent a gastric sleeve on (b)(6) 2020, and was discharged the next day.The patient came for labs on (b)(6) 2020, and had increased ldh and was admitted for suspected pump thrombosis he remained in the hospital until (b)(6) 2020.Pump thrombosis was not confirmed.The ramp study and ct scan were all negative.The patient had one day of dark colored urine, but otherwise was asymptomatic.The patient remained admitted until (b)(6) 2020, on integrilin and heparin which were stopped a week prior to dicharge.Patient continued to come to clinic bi-weekly for labs.

Manufacturer Narrative

Section b5: additional information.No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed.

Manufacturer Narrative

Manufacturer's investigation conclusion: a direct correlation between the device and the reported elevated ldh could not be conclusively determined through this evaluation.Three log files were submitted for review.Throughout the captured data, numerous pi events were captured.Prior to and after these events, the pump appeared to function as intended and no other unusual alarms or events were captured.No other atypical events were captured.The patient remains ongoing on heartmate ii lvas, serial number (b)(6).No product is available for investigation.The relevant sections of the device history records for (b)(6) were reviewed and showed no deviations from manufacturing or quality assurance specifications.The pump shipped on 30apr2015.The heartmate ii lvas ifu lists hemolysis as an adverse event that may be associated with the use of the heartmate ii left ventricular assist system.No further information was provided.The manufacturer is closing the file on this event.

• 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: 10641967
• MDR Text Key: 210222153
• Report Number: 2916596-2020-04974
• 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,Followup
• Report Date: 01/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/31/2017
• Device Model Number: 106015
• Device Catalogue Number: 106015
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 40 YR
• Patient Weight: 123