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

Model Number 104911

Device Problems Break (1069); Pumping Stopped (1503); Low Readings (2460); Material Split, Cut or Torn (4008)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/05/2020

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

The patient experienced low speed and pump stoppage events.The patient has a history of driveline repair.Log file analysis confirmed the pump stoppage event on (b)(6) 2020 and the low speed event on (b)(6) 2020.No further information was reported.

Manufacturer Narrative

Section d4, h4: additional information; section d4: corrected data; manufacturer¿s investigation conclusion: pump stoppages and low speed events were confirmed via the analysis of the submitted log file; however, a specific cause for the events could not be conclusively determined.Based on experience with the heartmate ii left ventricular assist system (lvas) and similar reported events, the pump stoppages and low speed advisory alarms that occurred while the patient was supported by batteries and the mpu could be indicative of driveline damage.The submitted log file contained data from (b)(6) 2020, through (b)(6) 2020.The log file captured pump stoppage events on (b)(6) 2020, and (b)(6) 2020, while the system was supported by battery power as well as low speed advisory alarms on (b)(6) 2020, while the system was supported by the mpu.No other atypical alarms or events were captured.The actual speed remained above the low speed limit for the remainder of the log file and pump appeared to be functioning as intended.Of note, the patient has a history of driveline repair documented in mfr report number 2916596-2015-01578.The relevant sections of the device history records were reviewed and showed no deviations from manufacturing or quality assurance specifications.The current heartmate ii lvas discusses pump speed, power, flow, and pulsatility index in section 1, ¿introduction¿.This ifu also outlines the indications of driveline damage, as well as how to respond to such events.The section entitled ¿alarms and troubleshooting¿ contains information regarding alarms on the system controller, including low speed/flow advisory/hazard alarms, driveline fault alarms, and pump off, and the proper actions associated with them.This section also provides information on driveline care and cleaning.The user should check the driveline daily for signs of damage (cuts, holes, tears) and call their hospital contact right away if the driveline is damaged (or might be damaged).The current heartmate ii lvas patient handbook contains a section on ¿caring for the driveline¿, however, all heartmate ii lvad drivelines have the potential for wire/shield breakdown to occur dependent upon length of use and movement/flexing over time.The section entitled ¿alarms and troubleshooting¿ contains information regarding alarms on the system controller, including low speed/flow advisory/hazard alarms, driveline fault alarms, and pump off, and the proper actions associated with them.In the event of a red heart/pump off alarm, the user is instructed to connect to a working power source right away and if connecting to power does not resolve the alarm, press any button on the system controller to attempt pump start and call your hospital contact immediately.The patient handbook also provides instructions in the event the pump stops in section 8 ¿handling emergencies¿.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE
• Type of Device: VENTRICULAR (ASSISST) BYPASS
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• MDR Report Key: 10264483
• MDR Text Key: 198534713
• Report Number: 2916596-2020-03310
• Device Sequence Number: 1
• Product Code: DSQ
• 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
• Report Date: 11/18/2020

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2016
• Device Model Number: 104911
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/24/2020
• Initial Date FDA Received: 07/13/2020
• Supplement Dates Manufacturer Received: 11/16/2020
• Supplement Dates FDA Received: 11/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 86 YR
• Patient Weight: 79