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

Model Number 106015

Device Problems Mechanical Problem (1384); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems No Consequences Or Impact To Patient (2199); Insufficient Information (4580)

Event Date 01/05/2020

Event Type  Death  

Manufacturer Narrative

This event was also reported against the system controller in mfr.Report #2916596-2020-00350.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 was at a rehab facility and became disoriented and cut the drive line (dl) instead of the anchoring device for the dl.The controller was replaced with the backup controller following malfunction after patient damaged dl; controller was exchanged at the rehab facility because the controller stopped per the nurse at the rehab facility.The log file analysis showed continuous drive line fault events starting on (b)(6) 2020 after the clock was set on the controller.These drive line fault appeared to be authentic as it appears the patient may have nicked a wire when he cut the drive line.Unable to download log files on faulted controller, the controller will not activate when power applied.

Manufacturer Narrative

Manufacturer's investigation conclusion: review of the log file provided by the account confirmed driveline fault alarms.Although a specific cause for these findings could not be conclusively determined as no product was returned for evaluation, based on previous complaint history, the events captured in the log file appeared consistent with potential driveline wire compromise.Furthermore, damage to the outer jacket of the external portion of the patient¿s driveline was confirmed through the account¿s submitted images.The submitted log file contained approximately 1 hour of relevant data from (b)(6) 2020 once the controller clock was set following the reported controller exchange.Continuous, silenced driveline fault alarms were captured throughout the relevant data.These alarms corresponded with yellow wrench advisory alarms and occurred while the patient was connected to the power module.Despite the observed alarms, no other atypical events were captured and the pump appeared to function as intended.The account reported that while at a rehab facility, the patient became disoriented and cut the driveline instead of the anchoring device for the driveline.The patient¿s controller had malfunctioned following the driveline damage and was reportedly exchanged.The patient was later transferred to st.Vincent¿s where the damage to the patient¿s driveline was repaired with rescue tape.Through additional information received on 06jan2020, the account requested to have the patient¿s driveline repair canceled, and stated that the patient was being medically managed and palliative care was being involved.The patient remains ongoing on heartmate ii lvas, serial number (b)(6) and no further events have been reported at this time.The hm ii lvas ifu and patient handbook provide information regarding how to care for the driveline and address damage due to wear and fatigue of the driveline.These documents outline indications of driveline wire damage as well as how to respond to such events, and further explain that all heartmate ii lvas drivelines have the potential for wire/shield breakdown to occur dependent on length of use and movement/flexing over time.Furthermore, these documents address all hazard and advisory alarm, as well as how to respond to each alarm condition.No further information was provided.The manufacturer is closing the file on this event.

Manufacturer Narrative

Manufacturer's investigation conclusion: review of the log file provided by the account confirmed driveline fault alarms.Although a specific cause for these findings could not be conclusively determined, based on previous complaint history, the events captured in the log file appeared consistent with potential driveline wire compromise.The damage to the outer jacket of the external portion of the patient¿s driveline was confirmed through the account¿s submitted images.Furthermore, the report of pump stop events could not be confirmed as no further log files were provided for review.The account reported that while at a rehab facility, the patient became disoriented and cut the driveline instead of the anchoring device for the driveline.The patient¿s controller had malfunctioned following the driveline damage and was reportedly exchanged.The patient was later transferred to st.Vincent¿s where the damage to the patient¿s driveline was repaired with rescue tape.The account later reported that the patient had had numerous pump stops through the night and was in the cardiothoracic vascular transplant unit (cvtu) on inotropes.The account requested to have the patient¿s driveline repair canceled and stated that the patient was being medically managed and palliative care was being involved.No further information was provided.The manufacturer is closing the file on this event.

Event Description

Additional information: the patient passed away on (b)(6) 2020.The cause of death was unknown but was not thought to be device or therapy related.

Manufacturer Narrative

Section d8 was corrected from blank.No further information was provided.A supplemental report will be submitted once the manufacturer's investigation is complete.

Manufacturer Narrative

Manufacturer's investigation conclusion: although no product was returned, damage to the patient¿s driveline was confirmed through the evaluation of the submitted images.Additionally, review of the log files provided by the account confirmed driveline fault alarms which appeared to be consistent with the report of the patient cutting the driveline.The reported pump stop events from the night of (b)(6) 2020, could not be confirmed as no further log files were provided for review.Furthermore, a direct correlation between heartmate ii left ventricular assist system (lvas), serial number (b)(6), and the reported patient outcome could not be conclusively established.The submitted log file contained approximately 1 hour of relevant data from 05jan2020 once the controller clock was set following the reported controller exchange.Continuous, silenced driveline fault alarms were captured throughout the relevant data.Electrical continuity data recorded during the driveline fault alarms suggested a potential issue with the black wire of the driveline.Despite the observed events, the pump appeared to function as intended and operated above the low speed limit.Heartmate ii lvas, serial number (b)(6), was not explanted for evaluation.It was communicated that no further information would be provided by the account.During the investigation, it was found that review of the submitted images revealed additional areas of tape on the external portion of the driveline indicating other areas of potential damage to the silicone jacket.The relevant sections of the device history records for (b)(6) and the driveline, serial number (b)(6) were reviewed and showed no deviations from manufacturing or quality assurance specifications.The heartmate ii lvas instructions for use (ifu) (rev.C) and the heartmate ii patient handbook (rev.C) are currently available.Section 1 of the ifu lists potential adverse events, including death, that may be associated with the use of the heartmate ii left ventricular assist system.Sections 6 and 8 of the ifu, as well as sections 4 and 6 of the patient handbook, provide information regarding how to care for the driveline and outline indications of driveline damage as well as the how to respond to such events.These documents also address damage due to wear and fatigue of the driveline and instruct the user to check their driveline daily for signs of damage, such as cuts, holes, or tears.The patient handbook also instructs the user to call their hospital contact right away if the driveline is damaged (or might be damaged).Section 7 of the hmii ifu and section 5 of the hmii patient handbook address all hazard and advisory alarms, as well as how to respond to each alarm condition.Furthermore, the patient handbook also contains a section on handling emergencies and further instructs the user to call their hospital contact if the patient thinks that, 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.

• Brand Name: HEARTMATE II LVAS IMPLANT KIT (WITH SEALED GRAFTS)
• Type of Device: VENTRICULAR (ASSIST) BYPASS
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 95488
• Manufacturer (Section G): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 95488
• Manufacturer Contact: bob fryc ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528204
• MDR Report Key: 9656095
• MDR Text Key: 177381173
• Report Number: 2916596-2020-00068
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024011224
• UDI-Public: 00813024011224
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P060040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 06/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2019
• Device Model Number: 106015
• Device Catalogue Number: 106015
• Device Lot Number: 5804190
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/14/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/05/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 57 YR
• Patient Sex: Male
• Patient Weight: 103 KG