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

Model Number 106015

Device Problems Mechanical Problem (1384); Obstruction of Flow (2423); Failure to Align (2522); Malposition of Device (2616); Infusion or Flow Problem (2964)

Patient Problems Thrombus (2101); Cardiogenic Shock (2262); Thrombosis/Thrombus (4440)

Event Date 07/06/2020

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

It was reported the patient will undergo a heartmate ii to heartmate iii pump exchange on (b)(6) 2020 due to pump malpositioning and suspected pump thrombosis.Patient experienced low flow alarms during hospitalization.The pump will be returned to abbott for analysis.

Event Description

It was reported that the suspected pump thrombosis was confirmed.A migrated cannula with repair was performed on (b)(6)2020.The patient experienced cardiogenic shock.Computed tomography of chest and echocardiograms were performed.

Manufacturer Narrative

Manufacturer's investigation conclusion: the report of pump malposition and suspected pump thrombosis could not be confirmed through this evaluation as no product was returned for evaluation and no images of the malposition or thrombus were provided.Additionally, a specific cause for the reported cardiogenic shock, as well as a direct correlation to heartmate ii lvas, serial number (b)(6), could not be determined.The account communicated that the patient was experiencing low flow alarms during his hospitalization.The patient was to reportedly undergo a pump exchange on (b)(6)2020 secondary to pump malpositioning and suspected pump thrombosis.Additional information indicated that the pump thrombosis was confirmed by the account and the cannula was migrated with a repair.The patient also experienced cardiogenic shock.As of the date of this report, heartmate ii lvas, serial number (b)(6), has not been returned for evaluation.This file will be closed accordingly.The heartmate ii lvas ifu lists device thrombosis as an adverse event that may be associated with the use of the heartmate ii left ventricular assist system.The hmii ifu provides details regarding the recommended anticoagulation therapy and inr range as well as outlines indications of pump thrombosis and as how to respond to such events.Additionally, the hmii ifu provides instructions regarding the installation and orientation of the sealed inflow conduit.This document states that care must be taken to avoid excessive angulation of the sealed inflow conduit once the left ventricular assist device is in-situ and the ideal orientation will anticipate that the dilated lv may shrink in size as its workload is assumed by the pump.No further information was provided.The manufacturer is closing the file on this event.

Manufacturer Narrative

Manufacturer's investigation conclusion: the report of pump malposition, suspected pump thrombosis, and low flow alarms could not be confirmed based on the provided information.Additionally, a specific cause for the reported cardiogenic shock, as well as a direct correlation to heartmate ii left ventricular assist system (lvas), serial number (b)(6), could not be determined.The account communicated that the patient was experiencing low flow alarms during his hospitalization.The patient also experienced cardiogenic shock.The patient was to reportedly undergo a pump exchange on (b)(6) 2020 secondary to pump malpositioning and suspected pump thrombosis.Additional information indicated that the pump thrombosis and left ventricle cannula migration was confirmed by the account.It was also clarified that no pump exchange was performed, and the heartmate ii was instead repositioned.The patient remained ongoing on heartmate ii lvas, serial number (b)(6), until they expired on (b)(6) 2020.The relevant sections of the device history records (b)(6) were reviewed and showed no deviations from manufacturing or quality assurance specifications.The heartmate ii lvas instructions for use (ifu), rev.H, 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 lists device thrombosis as an adverse event that may be associated with the use of heartmate ii left ventricular assist system in section 1, ¿introduction¿.An explanation of each pump¿s parameters can also be found in this section.Section 6, ¿patient care and management¿, outlines indications of pump thrombosis and how to respond to such events.Section 6 also outlines the suggested anticoagulation therapy and inr range for patient using the heartmate ii lvas.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.Per design, when the estimated flow value is calculated at less than 2.5 lpm, a low flow status is posted to the log file.If the flow remains below 2.5 lpm for 10 seconds, a low flow hazard alarm is triggered.Heartmate ii patient handbook (rev.G) contains a section on ¿alarms and troubleshooting¿ which provides information on all system alarms, including low flow hazard alarms, and the actions associated to resolve the alarms.A section on ¿handling emergencies¿ is also provided.No further information was provided.The manufacturer is closing the file on this event.

Event Description

Additional information reported that the pump was repositioned secondary to substantial pressure over time which resulted in left ventricle cannula migration.Revision of the migrated cannula was performed.It was confirmed that the patient did not have a pump exchange at the time.

• 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
• 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: 10319488
• MDR Text Key: 200431350
• Report Number: 2916596-2020-03507
• 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
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 01/17/2024

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?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/08/2021
• Device Model Number: 106015
• Device Catalogue Number: 106015
• Device Lot Number: 6925147
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/06/2020
• Initial Date FDA Received: 07/24/2020
• Supplement Dates Manufacturer Received: 09/17/2020; 01/03/2024
• Supplement Dates FDA Received: 10/09/2020; 01/17/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/28/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 46 YR
• Patient Sex: Male
• Patient Weight: 138 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American