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

Model Number 106015

Device Problems Obstruction of Flow (2423); Infusion or Flow Problem (2964)

Patient Problems Hemolysis (1886); Hemorrhage/Bleeding (1888); Obstruction/Occlusion (2422); Thrombosis/Thrombus (4440); Lactate Dehydrogenase Increased (4567)

Event Date 02/13/2022

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 that the patient¿s log file was submitted for review due to concern for pump thrombosis.The patient was admitted from the emergency room on (b)(6) 2022 with labs notable for lactate dehydrogenase (ldh) 2,260 u/l with subtherapeutic international normalized ratio (inr) of 1.2 on (b)(6) 2022.The patient had a history of poor follow-up and anticoagulation management.Log file submitted contained multiple low flow alarms with low speed advisory and pump stop while connected to batteries on (b)(6) 2022.There was an increase in power and decrease in pulsatility index (pi) which occurred.The data showed 108 low speed operation, 150 low flow hazard and 65 pump stops.Speed drops were as low as 0rpm.The patient¿s pump was turned off on (b)(6) 2022 due to hemolysis and increasing power.The patient underwent a pump exchange from heartmate ii to heartmate 3 on (b)(6) 2022 and was reported to be stable and in recovery.No additional information provided.

Manufacturer Narrative

Manufacturer's investigation conclusion: a correlation between the heartmate ii lvas and the reported elevated ldh, elevated pump powers, and suspected thrombus could not be conclusively established through this evaluation.Additionally, a direct correlation between heartmate ii lvas, serial number (b)(6), and the reported events could not conclusively be established through this evaluation.The submitted log file captured multiple pump stops and low-speed events, as well as associated alarms, were captured throughout the entirety of the log file between 13feb2022 at 06:04:57 through 14:16:04.Each of the events occurred while the system was operating on battery power.Based on previous complaint experience, the captured events appear consistent with a potential driveline wire compromise.Towards the end of the log file, the fixed speed was set to 9400 rpm; power typically ranged from 8.9-25.5 watts; flow typically ranged from 0.3-12 lpm; and the average pi typically ranged from 0-3.2.(b)(6) was returned assembled with the driveline (dl) cut approximately 0.25¿ from the pump housing and the distal portion of the dl was not returned.All parts of the sealed inflow conduit (the inlet tube, inflow conduit flex section, and inlet elbow) were returned attached to the pump.The sealed outflow conduit was returned attached to the pump outlet housing.The bend relief collar was also present.The pump appeared to have been exposed to a fixative prior to return.Visual examination of the pump¿s blood-contacting surfaces upon disassembly of (b)(6) revealed fixed blood, however, no adhered depositions or thrombus formations.The disassembled pump's bearings, rotor, and blood-contacting surfaces were examined under a microscope and no anomalies were observed.Electrical continuity testing of the driveline did not reveal any discontinuities or shorts.Visual inspection of the driveline did not reveal any damage to the insulation of the wires.Hipot testing was not performed due to the length of the driveline.The pump was cleaned, reassembled, and functionally tested under normal operating conditions using a mock circulatory loop.The data retrieved from that testing revealed normal pump power consumption and pressure values that met manufacturing specifications and the device functioned as intended.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 shipped on 23dec2016.The heartmate ii lvas ifu is currently available.Section 1 of this ifu lists device thrombosis and hemolysis as adverse events that may be associated with use of the heartmate ii left ventricular assist system.Pump speed, power, flow, and pi are addressed in section 1 of this ifu.Additionally, section 6 "patient care and management" outlines the recommended anticoagulation therapy and inr range.This section also outlines indications of pump thrombosis, as well as how to respond to such events.The section "system operations" describes the "driveline" and outlines indications of driveline damage as well as how to respond to such events.The section "equipment storage and care" describes "care of the driveline." the section "alarms and troubleshooting" outlines alarms and how to respond to them, including pump stops and low speed events.The heartmate ii lvas patient handbook is currently available.Section 4 of this 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.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: 13713661
• MDR Text Key: 288184264
• Report Number: 2916596-2022-00988
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 05/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/31/2019
• Device Model Number: 106015
• Device Catalogue Number: 106015
• Device Lot Number: 5786112
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/26/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/29/2016
• 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 Outcome(s): Required Intervention; Hospitalization
• Patient Age: 43 YR
• Patient Sex: Male
• Patient Weight: 83 KG