MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE 3 LVAS IMPLANT KIT; VENTRICULAR (ASSISST) BYPASS

Model Number 106524US

Device Problems Alarm Not Visible (1022); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems High Blood Pressure/ Hypertension (1908); Gastrointestinal Hemorrhage (4476)

Event Date 11/09/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that the patient had low flow alarms on (b)(6) 2021 and had ongoing low flow alarms since their index hospitalization at that facility.The low flows were believed to be likely due to hypertension.The patient's mean arterial pressure (map) was 88 in clinic on (b)(6) 2021 and hydralazine was added to their treatment regimen.Log file analysis confirmed low flow alarms on (b)(6) 2021.It was reported on (b)(6) 2021 that the patient had experienced further low flow alarms that did not display on the controller or system monitor at the time of the alarm.Per log file analysis, 3 low flow alarms with high pulsatility index (pi) were triggered and there were 9 other low flow advisory events that did not last long enough to trigger an alarm.It was additionally reported on (b)(6) 2021 that the low flow alarms were due to hypertension and gastrointestinal bleeding.The low flows resolved with better mean arterial pressure (map) control and the patient was reported to be stable.A push enteroscopy was pending.It was additionally reported on (b)(6) 2021 that the patient's capsule study and push enteroscopy did not show any active bleeding.Anticoagulation was thus resumed and an outpatient colonoscopy was pending.

Manufacturer Narrative

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

Event Description

It was reported that the patient had low flow alarms on (b)(6) 2021 and had ongoing low flow alarms since their index hospitalization at that facility.The low flows were believed to be likely due to hypertension.The patient's mean arterial pressure (map) was 88 in clinic on (b)(6) 2021 and hydralazine was added to their treatment regimen.Log file analysis confirmed low flow alarms on (b)(6) 2021.It was reported on (b)(6) 2021 that the patient had experienced further low flow alarms that did not display on the controller or system monitor at the time of the alarm.Per log file analysis, 3 low flow alarms with high pulsatility index (pi) were triggered and there were 9 other low flow advisory events that did not last long enough to trigger an alarm.It was additionally reported on (b)(6) 2021 that the low flow alarms were due to hypertension and gastrointestinal bleeding.The low flows resolved with better mean arterial pressure (map) control and the patient was reported to be stable.A push enteroscopy was pending.It was additionally reported on (b)(6) 2021 that the patient's capsule study and push enteroscopy did not show any active bleeding.Anticoagulation was thus resumed and an outpatient colonoscopy was pending.

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported low flow alarms were confirmed via the submitted log file data.According to the account, the low flows were due to hypertension and gastrointestinal bleeding.A direct correlation between heartmate 3 left ventricular assist system, serial number (b)(6), and the reported hypertension / gastrointestinal bleeding could not conclusively be determined.Controller event log file 20211109_034552 contained data on (b)(6) 2021 spanning from 09:30:56 to 16:20:08, per the timestamp.Numerous low flow events were captured throughout the log file when the estimated pump flow was calculated to be below the threshold of 2.5 liters per minute (lpm).A total of 28 low flow events persisted for at least 10 seconds, activating low flow alarms.No other notable alarms were captured.The controller event log file contained data spanning from (b)(6) 2021 at 14:42:19 to (b)(6) 2021 at 10:17:30, per the timestamp.Intermittent low flow events were captured on (b)(6) 2021 and (b)(6) 2021 when the estimated pump flow was calculated to be below the threshold of 2.5lpm.A total of 3 low flow events persisted for at least 10 seconds, activating low flow alarms.No other notable alarms were captured.The controller event log files appeared to have captured the pump operating as intended.The patient was seen in the clinic due to low flow alarms.The patient has reportedly had ongoing low flow alarms since being discharged from their ventricular assist device (vad) implant procedure.The patient¿s mean arterial pressure (map) was noted to be 88 millimeters of mercury (mmhg) in the clinic and the patient was started on hydralazine.The account later communicated that the cause of the low flow alarms was due to hypertension and gastrointestinal bleeding, and the alarms resolved with better map control.The patient underwent a capsule study and a push enteroscopy, which did not reveal any active lesions/bleeding.The patient¿s anticoagulation regimen has since been resumed and an outpatient colonoscopy procedure was to be performed.The patient remains ongoing on heartmate 3 left ventricular assist system, serial number (b)(6).The relevant sections of the device history records were reviewed and showed no deviation from manufacturing or quality assurance specifications.The heartmate 3 left ventricular assist system instructions for use, rev.C, contains the following information: section 1 lists bleeding and hypertension as adverse events that may be associated with the use of heartmate 3 left ventricular assist system.Speed, power, flow, and pulsatility are also outlined in this section.Section 4 describes the pump flow display and the hazard alarms.This section also states that the low flow hazard alarm will be triggered when pump flow is less than 2.5 liters per minute (lpm) and explains that changes in patient conditions can result in low flow.Section 6 provides information regarding the recommended anticoagulation therapy and international normalized ratio range.Is also included in this section.Section 7 describes the actions to take in the event of a low flow alarm.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: HEARTMATE 3 LVAS IMPLANT KIT
• 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: 12968471
• MDR Text Key: 285365047
• Report Number: 2916596-2021-07092
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024013297
• UDI-Public: 00813024013297
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P160054
• 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: 02/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/22/2023
• Device Model Number: 106524US
• Device Catalogue Number: 106524US
• Device Lot Number: 8099164
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/17/2021
• 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: 52 YR
• Patient Sex: Female
• Patient Weight: 47 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American