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

Model Number 106015

Device Problems Insufficient Flow or Under Infusion (2182); Infusion or Flow Problem (2964); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Death (1802); Renal Failure (2041)

Event Date 08/20/2020

Event Type  Death  

Manufacturer Narrative

Patient death was previously reported on the original pump in mfr 2916596-2020-04271.No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed.

Event Description

The patient exhibited low flows after the pump exchange.The patient expired on (b)(6)2020.It was reported the family withdrew care.The patient had remained on high doses of pressors and continuous veno-venous hemofiltration.

Manufacturer Narrative

Patient death is addressed under this report as this report includes the most recently implanted pump (serial # (b)(6)).The serious injury while the patient receiving support from the original pump (serial # (b)(6)) is addressed under mfr # 2916596-2020-04271.No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed.

Manufacturer Narrative

Manufacturer investigation conclusion: a direct correlation between the device and the reported events could not be conclusively established through this evaluation.Additionally, the reported low flows could not be confirmed through this evaluation as no log files were provided.Furthermore, a specific cause of the reported low flows could not conclusively be determined through this evaluation multiple requests for additional information, including the return status of the device, were sent to the customer; however, no response has been received at this time.The device history records were reviewed and showed no deviations from manufacturing or quality assurance specifications.Implant kit was shipped to the customer on (b)(6) 2017.The current revision of the heartmate ii left ventricular assist system (lvas) instructions for use (ifu) lists adverse events that may be associated with the use of the heartmate ii left ventricular assist system, including death and renal dysfunction.Pump performance monitoring outlines different pump parameters and describes how pump performance is sensitive to changes in systemic vascular resistance and left ventricular filling.The pump flow section explains that pump flow is estimated based on pump power.Additionally, the ifu explains that physiological factors that affect the filling of the pump, such as hypovolemia or postural hypotension, can result in reduced pump flows as long as the condition persists.The alarms and troubleshooting section of this ifu describes all alarm conditions, including the low flow hazard alarm.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: 10692998
• MDR Text Key: 211890515
• Report Number: 2916596-2020-05212
• 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: health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/31/2020
• Device Model Number: 106015
• Device Catalogue Number: 106015
• Device Lot Number: 6171030
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Hospitalization
• Patient Age: 71 YR
• Patient Weight: 101