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); Infusion or Flow Problem (2964); Naturally Worn (2988)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/06/2022

Event Type  malfunction  

Event Description

It was reported that the patient had some wear and tear on the driveline and was stable.The log files revealed low flow hazard alarms which were not associated with any sort of external equipment malfunction.The log files did not contain any alarms associated with driveline wire damage.The reported damage to the outer jacket appeared cosmetic.

Manufacturer Narrative

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

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported damage to the patient¿s driveline could not be confirmed as no product was returned for evaluation and no images of the damage were provided for review.Additionally, review of the log files provided by the account confirmed low flow alarms.Although a specific cause for these events could not be conclusively determined, the account reported that the alarms were caused by dehydration.A direct correlation between heartmate (hm) ii left ventricular assist system (lvas), serial number (b)(6) , and the reported dehydration could not be conclusively established.The submitted log file contained data from (b)(6) 2022, per the timestamps.Transient low flow alarms were captured on (b)(6) 2022, when the estimated flow dropped below the low flow threshold of 2.5 lpm, to a range of 2.3-2.4 lpm.Despite the observed events, the pump appeared to function as intended and operated at or above the low speed limit for the duration of the file.The patient remains ongoing on heartmate ii lvas, serial number (b)(6) , and no further related events have been reported at this time.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 02mar2016.The heartmate ii lvas instructions for use (ifu) and the heartmate ii patient handbook are currently available.Section 1 of the ifu lists potential adverse events that may be associated with the use of the heartmate ii left ventricular assist system.Section 1 of the ifu also addresses all pump parameters, including pump flow.Section 4 of the ifu describes situations which may result in a low flow hazard alarm, including changes in patient condition such as hypertension.Per design of the system, once each monitoring cycle, the calculated average flow value is compared to the limit (2.5 lpm).If the calculated value is less than the expected value, a low flow hazard is posted to the log file.A ten second delay is imposed between the detection of a low flow hazard alarm condition and the activation of the associated audio and visual indicators on the controller.Section 6 of the ifu explains that pump flow is estimated from pump power and pump performance is sensitive to changes in systemic vascular resistance and left ventricular filling.This section further 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.Sections 6 and 8 of the ifu, as well as sections 4 and 6 of the hmii patient handbook, provide information regarding how to care for the driveline and address damage due to wear and fatigue of the driveline.Section 7 of the ifu and section 5 of the patient handbook describe all alarm conditions as well as the appropriate actions associated with each condition.Additionally, several sections of the hmii ifu and patient handbook warn that batteries should not be used to power the system when the patient is sleeping.These sections state that the patient must always connect to the power module for sleeping or when there is a chance of sleep, as a sleeping patient may not hear the system controller alarms.No further information was provided.The manufacturer is closing the file on this event.

Event Description

The low flows were caused by dehydration and resolved with fluids.The patient was asymptomatic.

Manufacturer Narrative

H6: correction - low flow alarm medical device problem code removed.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 94588
• Manufacturer (Section G): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• Manufacturer Contact: bob fryc ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528204
• MDR Report Key: 14654601
• MDR Text Key: 295434879
• Report Number: 2916596-2022-11650
• 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: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/31/2019
• Device Model Number: 106015
• Device Catalogue Number: 106015
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/24/2016
• 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 Age: 71 YR
• Patient Sex: Female
• Patient Weight: 75 KG