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); Infusion or Flow Problem (2964); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abdominal Pain (1685); Fatigue (1849); Ischemia (1942); Obstruction/Occlusion (2422); Thrombosis/Thrombus (4440)

Event Date 02/15/2022

Event Type  Injury  

Event Description

It was reported that the patient presented to the emergency department with fatigue, abdominal pain, and low hemoglobin.The left ventricular assist device (lvad) appeared to be stable, however a flow of 11.1 lpm was noted in the event log on (b)(6) 2022.Patient has a history of pump thrombus.Lactate dehydrogenase (ldh) and plasma hemoglobin were within normal limits.The additional log file captured more power/flow spikes on (b)(6) 2022.Hemolysis markers were normal.The patient was primarily complaining of abdominal pain.The log file captured a short period of elevated powers on (b)(6) 2022 with powers noted between 8-11w.These above baseline powers were all associated with pi (pulsatility index) events.With such an abrupt change in pump power and return to baseline it was possible something may have passed through the pump.A few flows around 8 lpm were observed on the event log.The patient denied pain, but was on propofol at time of event.The reason for the abdominal pain was ischemic bowel.A small bowel resection with initial partial fenestrated cholecystectomy which was later upgraded to a complete cholecystectomy was done.The cause of the elevated pump power/flow was not identified, but ingestion and showing of thrombus to gut causing ischemic bowel was suspected.The elevated pump power/flow resolved.It was not believed there was occlusion of the pump.The patient was admitted to hospital status post emergent trauma surgeries noted.The patient was awake and oriented on multiple iv (intravenous) drugs as they recovered.

Manufacturer Narrative

History of pump thrombus reported under mfr # 2916596-2020-01666.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 report of ingested pump thrombus could not be confirmed through this evaluation as no product or images are available for investigation.Review of the submitted log files confirmed elevations in pump power and estimated flow; however, a specific cause for these events could not be conclusively determined through this evaluation.Additionally, a direct correlation between heartmate ii left ventricular assist system (lvas), serial number (b)(6), and the reported event of a showering of thrombus resulting in ischemic bowel could not be conclusively established through this evaluation.The submitted log files contained data from (b)(6) 2022 through (b)(6) 2022 and (b)(6) 2022 through (b)(6) 2022.A transient elevation in pump power and estimated flow was captured on (b)(6) 2022.Additional elevations in pump power and flow were captured on (b)(6) 2022, with minor elevations above the patient's baseline on (b)(6) 2022.Of note, the majority of the elevations were captured during pulsatility index (pi) events.No other notable events or alarms were captured.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).It should be noted that the patient had additional power elevations in (b)(6) 2022 (mfr # 2916596-2022-01791).The relevant sections of the device history records for (b)(6) were reviewed and showed no deviations from manufacturing or quality assurance specification.The heartmate ii left ventricular assist system (lvas) instructions for use (ifu) is currently available.Section 1, ¿introduction¿ lists adverse events that may be associated with the use of the heartmate ii lvas, including pump thrombosis and peripheral thromboembolic events.This section also addresses pump speed, power, flow, pulsatility index (pi), and explains that pump power is a direct measurement of motor voltage and current; therefore, changes in pump speed, flow, or physiological demand can affect pump power.This document also describes how pump performance is sensitive to changes in systemic vascular resistance and left ventricular filling.Section 6, ¿patient care and management¿, lists thromboembolism as a potential late post-implant complication that may be associated with the use of heartmate ii lvas, outlines indications of thrombus, and states how to respond to such events.This section also discusses anticoagulation, including recommended international normalized ratio (inr) values.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
• 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: 13792188
• MDR Text Key: 287827684
• Report Number: 2916596-2022-01200
• 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
• Report Date: 04/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/31/2020
• Device Model Number: 106015
• Device Catalogue Number: 106015
• Device Lot Number: 5975944
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/21/2017
• 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: 73 YR
• Patient Sex: Male
• Patient Weight: 109 KG