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

Model Number 106016

Device Problems Failure to Align (2522); Malposition of Device (2616)

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

Event Date 02/09/2021

Event Type  malfunction  

Manufacturer Narrative

No further information was provided.The results/method and conclusion codes along with investigation results will be provided in the final report.

Event Description

It was reported that the patient had elevated power/flows associated with pi events.The patient was recently implanted with a new heartmate ii pump on (b)(6) 2021 due to suspected short-to-shield.Malposition of inflow cannula was the suspected cause, which the patient was known to have.Currently the patient has no symptoms.Blood lab analysis did not reveal hemolysis markers and blood pressure is in normal range.There was no blood in urine analysis.Echocardiogram did not show lv unloading issues.The patient is currently on fluid management and optimalisation of pump rpm speed.

Manufacturer Narrative

Section b5: recent pump exchange is reported in mfr #2916596-2021-00021.Correction: new heartmate ii pump was implanted on (b)(6) 2021, not (b)(6) 2021 as previously mentioned.Manufacturer's investigation conclusion: evaluation of the submitted log files confirmed pump power and flow elevations.Although a specific cause for these elevations could not conclusively be determined, the account contributed them to inflow malalignment.The submitted log file contained data from (b)(6) 2021 at 22:27:54 to (b)(6) 2021 at 11:50:16.The pump speed was set at 8600 rpm with a low speed limit of 8000 rpm.On (b)(6) 2021 there were numerous captured events where the pump power and calculated flow was elevated ranging from 7.0-7.4 watts and 9.0-10.5 lpm respectively.Additionally, these pump power and flow elevations appeared to be associated with pi events.The only other captured events were associated with power cable disconnects.The pump operated above the low speed limit of 8000 rpm for the duration of the captured data.The pump appeared to operate as expected.The patient remains on going 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 was shipped on 08aug2018.The heartmate ii lvas ifu is currently available.Section 5, ¿surgical procedures¿ outlines considerations for pump placement and orientation and also provides instructions regarding the preparation, installation, and orientation of the sealed inflow conduit.Section 5 (under ¿inserting the sealed inflow conduit¿) states to ¿select the optimal sealed inflow conduit orientation at the ventricular apex.The following is critical in determining orientation: the opening of the sealed inflow conduit should be directed toward the mitral valve and away from the intraventricular septum.Care must be taken to avoid excessive angulation of the sealed inflow conduit once the left ventricular assist device is in-situ.The ideal orientation will anticipate that the dilated lv may shrink in size as its workload is assumed by the pump.¿ the hmii ifu also contains a section on ¿pump performance monitoring¿ under patient care and management which explains that pump performance is sensitive to changes in systemic vascular resistance and left ventricular filling.Section 4.4 ¿clinical screen¿, contains sections on pump flow, pump speed, pulsatility index, and pump power.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: 11327616
• MDR Text Key: 234488238
• Report Number: 2916596-2021-00826
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 04/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/28/2021
• Device Model Number: 106016
• Device Catalogue Number: 106016
• Device Lot Number: 6538461
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1