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

Model Number 106015

Device Problem Infusion or Flow Problem (2964)

Patient Problems High Blood Pressure/ Hypertension (1908); Pleural Effusion (2010)

Event Date 08/15/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that the patient had log files sent in for low flow alarms.At the time of the initial alarms the patient was hypertensive with doppler mean arterial pressures (maps) in the range of 100-120 mmhg.The alarms resolved with a decrease in blood pressure (bp), but they began again after.The patient appeared to be euvolemic on the exam and their doppler map was in the 70-80 mmhg range.The log files captured persistent low flow alarms on (b)(6) 2021 when the flows appeared to be fluctuating below the alarm threshold of 2.5 lpm.Additional log files were sent on (b)(6) 2021 and multiple strings of low flows were seen.These still appeared to be due to a patient related issue.The log also displayed one transient low speed advisory on (b)(6) 2021 at 06:16 because the pump set speed (7800 rpm) was momentarily set lower than the low speed limit (8800 rpm).The patient received multiple blood products and ivfs, which resolved the alarms.Upon investigation it was found that along with hypertensive issues, the patient had eccentric 90% stenosis of the outflow graft near the aorta with a significant gradient of 90 mmhg across the lesion.The patient's outflow graft was stented in interventional radiology (ir).The patient remained hemodynamically stable and felt well throughout the situation and was discharged the following day with resolution of symptoms and alarms.Follow-up log files were sent and intermittent low flow events were seen between (b)(6) 2021 at 18:55 and (b)(6) 2021 at 13:59.Between (b)(6) 2021 at 14:31 and (b)(6) 2021 at 12:24 the pump parameters were noted to be in normal range.The patient had been feeling well since discharge and had no further complaints.

Manufacturer Narrative

Manufacturer's investigation conclusion: incidental findings: review of the log files revealed elevated power and flows.A direct correlation between heartmate ii lvas, serial number (b)(6), and the reported events, including outflow graft obstruction, could not be conclusively established during this evaluation.Furthermore, review of the submitted log file confirmed low flow hazard alarms and revealed power changes; however, a specific cause for these events, could not be conclusively determined.The submitted log file contained data from 22:12:40 on (b)(6) 2021 through 12:05:33 on (b)(6)2021, per the timestamps.Transient low flow hazards were detected throughout the log file with flows dropping to a range of 2.1-2.4 lpm.The observed low flow events did not appear to be associated with elevations in pump power or pi events.The pump operated above the low speed limit for the duration of the log file.Despite the observed events, the pump appeared to be operating as intended.The second and third submitted log files contained data from 05:38:43 through 08:40:34 on (b)(6) 2021, per the timestamps.The pump¿s fixed speed and low speed limit were 9200 rpm and 8800 rpm, respectively.The fixed speed was briefly lowered to 7800 rpm at 06:15:34 on (b)(6) 2021, causing the pump speed to briefly fall below the low speed limit.Pump power, estimated flow, and average pi typically ranged from 2.9-4.2 watts, 2.2-2.6 lpm, and 3.5-4.9, respectfully.Transient low flow hazards were detected throughout the log file with flows dropping to a range of 2.2-2.4 lpm.The observed low flow events did not appear to be associated with elevations in pump power or pi events.The pump operated above the low speed limit for the duration of the log file.Despite the observed events, the pump appeared to be operating as intended.The fourth submitted log file contained data from 18:55:37 on (b)(6) 2021 through 12:24:20 on (b)(6) 2021, per the timestamps.Intermittent low flow hazards were detected throughout the log file with flows dropping to 2.4 lpm.The observed low flow events did not appear to be associated with elevations in pump power or pi events.Throughout the captured data, elevations in pump power as high as 7.8 w were captured.Corresponding elevations in pump flow, as high as 9.3 lpm, were also captured.The pump operated above the low speed limit for the duration of the log file.Despite the observed events, the pump appeared to be operating 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 was shipped on (b)(6) 2018.The heartmate ii lvas ifu and the heartmate ii patient handbook are currently available.Section of the ifu, ¿introduction¿, lists hypertension as a potential adverse event that may be associated with the use of the heartmate ii left ventricular assist system.Section ¿surgical procedures¿ outlines considerations for pump placement and provides instructions regarding the preparation, installation, and orientation of the sealed outflow graft.Section, under ¿attaching the sealed outflow graft¿, cautions that the sealed outflow graft must not be kinked or positioned where it could abrade against a pump component or body structure.The user is instructed to verify that the graft is not twisted or kinked by checking the position of the black line on the graft above and below the bend relief.The line should be straight.The ifu contains information regarding pump speed, power, flow, and pi.The ifu 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.The ifu 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 ¿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 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 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: 12493421
• MDR Text Key: 272124599
• Report Number: 2916596-2021-04887
• 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 Practitioner
• Type of Report: Initial,Followup
• Report Date: 11/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/30/2020
• Device Model Number: 106015
• Device Catalogue Number: 106015
• Device Lot Number: 6289748
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/24/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/05/2018
• 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): Hospitalization; Required Intervention
• Patient Age: 79 YR
• Patient Sex: Male
• Patient Weight: 70 KG