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

Model Number 106015

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

Patient Problems Anemia (1706); Fatigue (1849); Dizziness (2194); Gastrointestinal Hemorrhage (4476); Melena (4480)

Event Date 12/25/2023

Event Type  Injury  

Event Description

It was reported that the patient was experiencing low flow alarms, and their stools were dark for a few days.The patient also reported dizziness.The ventricular assist device (vad) parameters included the speed being at 8600 rotations per minute (rpm), backup speed at rpm 8200, power of 4.3 watts, estimated flow of 3.5 liters per minute, pulsatility index (pi) of 6.5, and a mean arterial pressure (map) of 86.The patient was routed to the emergency department.Low voltage advisory and 17 low flow alarms were reported on vad interrogation.It was noted that the patient had a history of symptomatic anemia secondary to gastrointestinal bleed and was on the medication octreotide as an outpatient.Log files were sent for review.The log file captured several low flow events.The plan was for admission and esophagogastroduodenoscopy (egd).

Manufacturer Narrative

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

Event Description

It was reported that the patient was experiencing low flow alarms due to low hemoglobin.The patient also reported fatigue.It was noted that the patient had a history of symptomatic anemia secondary to gastrointestinal bleed, starting on (b)(6) 2023, and was on the medication octreotide as an outpatient.Log files were sent for review.It was later reported that the low flow alarms resolved by repleting blood by a transfusion.The bleeding was confirmed, and the sources were multiple angiodysplasia in the duodenum and jejunum.The bleeding was treated with ablation with 1 active bleeding angiodysplasia remaining in the jejunum.

Manufacturer Narrative

Manufacturer's investigation conclusion: a direct correlation between heartmate ii left ventricular assist system (lvas), serial number (b)(6) and the reported gastrointestinal bleeding, could not be conclusively established.Additionally, the report of low flow alarms was confirmed via the submitted log files.According to the account, the low flows were due to low hemoglobin.Analysis of the submitted log file revealed low flow events on 25dec2023 and 26dec2023 when the flow decreased below the 2.5 liters per minute (lpm) alarm threshold.The pump appeared to function as intended and operated at the fixed speed without issue for the duration of the file.The patient remains ongoing on heartmate ii lvas, serial number (b)(6) with no further issues reported at this time.The relevant sections of the device history records for (b)(6) were reviewed and showed no deviations from manufacturing or quality assurance specifications.The heartmate ii lvas instructions for use (ifu), rev.C, and the heartmate ii lvas patient handbook, rev.C, are currently available.Section 1 of this ifu lists bleeding as an adverse event that may be associated with the use of the hm ii lvas.This document also provides information regarding the recommended anticoagulation therapy and international normalized ratio (inr) range, as well as the suggested anticoagulation modifications in the event that there is a risk of bleeding.Pump speed, power, flow, and pi are also addressed in section 1.The ifu notes that the low flow alarm is triggered when the flow is less than 2.5 lpm.Section 7 of the ifu, ¿alarms and troubleshooting¿, and section 5 of the patient handbook, ¿alarms and troubleshooting¿, describe alarm conditions, including the low flow hazard, as well as the appropriate actions associated with them.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: lindsey sallese ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528207
• MDR Report Key: 18448025
• MDR Text Key: 332154899
• Report Number: 2916596-2024-00055
• 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: 03/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/31/2017
• Device Model Number: 106015
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/04/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/25/2014
• 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: 78 YR
• Patient Sex: Female
• Patient Weight: 87 KG