MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM; VENTRICULAR (ASSISST) BYPASS

Model Number 106524

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Anemia (1706); Gastritis (1874); Hemorrhage/Bleeding (1888); Weakness (2145); Dizziness (2194)

Event Date 09/25/2020

Event Type  Injury  

Manufacturer Narrative

The heartmate 3 lvas was implanted during the (b)(6) clinical trial, ide# g140113.Fda approval for heartmate 3 lvas was received on 23 august 2017.The same device is used commercially and in the ongoing (b)(6) trial.The gtin unique device identifier for the commercial heartmate3 lvas is (b)(4).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 was admitted with complaints of weakness, dizziness and lightheadedness.The patient was admitted for anemia.Hemoglobin and hematocrit dropped to 9.6 and 32.5.Aspirin and coumadin were placed on hold.A video capsule endoscopy was obtained that showed gastritis and duodenitis, but no signs of bleeding.The patient was given iv protonix and was then transitioned to oral protonix.The patient was instructed to continue the protonix at discharge.Aspirin was stopped indefinitely and coumadin was resumed.The patient had no further complaints and was discharged to home on (b)(6) 2020 with hemoglobin and hematocrit of 10.2 and 34.4.The patient did not receive any blood products while hospitalized.Upon admission it was noted that the modular cable had visible damage to the mesh and broken integrity to the cable.The wires inline were exposed.The modular cable was exchanged.Manufacturer report number of modular cable: 2916596-2020-05093.

Manufacturer Narrative

Section d4, h4: additional information.Manufacturer's investigation conclusion: a specific cause for the reported anemia could not be conclusively determined through this evaluation.In addition, a direct correlation with heartmate 3 left ventricular assist system (lvas), serial number (b)(6), could not be conclusively established.It was reported that the patient was admitted to the hospital on (b)(6) 2020 for anemia and low hemoglobin and hematocrit values.An endoscopy was performed, and no signs of bleeding were found.Changes were made to the patient¿s medications, and the patient was discharged to home on (b)(6) 2020.The patient did not receive any blood products while hospitalized.The patient remains ongoing on heartmate 3 lvas, serial number (b)(6), and no further related issues have been reported at this time.The heartmate 3 lvas instructions for use (ifu) lists adverse events that may be associated with the use of the heartmate 3 left ventricular assist system.In addition, this document outlines the recommended anticoagulation regimen (including inr range) as well as the suggested anticoagulation modifications in the event there is a risk of bleeding.The relevant sections of the device history records for (b)(6) were reviewed and showed no deviations from manufacturing or quality assurance specifications.The pump shipped on (b)(6) 2016.Although the reported information indicated that no bleeding source was found in association with the anemia, the heartmate 3 left ventricular assist system (lvas) instructions for use (ifu) lists bleeding as an adverse event that may be associated with the use of the heartmate 3 left ventricular assist system.Section 6 ¿patient care and management¿ (under "anticoagulation") outlines the recommended anticoagulation regimen (including inr range) for patients using the heartmate 3 lvas as well as the suggested anticoagulation modifications if there is a risk of bleeding.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM
• Type of Device: VENTRICULAR (ASSISST) BYPASS
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• MDR Report Key: 10677633
• MDR Text Key: 211365494
• Report Number: 2916596-2020-05092
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024013297
• UDI-Public: 813024013297
• Combination Product (y/n): N
• PMA/PMN Number: P160054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: study
• Type of Report: Initial,Followup
• Report Date: 11/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/01/2019
• Device Model Number: 106524
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: HEART MATE 3 LEFT VENTRICULAR ASSIST SYSTEM; HEART MATE 3 LEFT VENTRICULAR ASSIST SYSTEM
• Patient Outcome(s): Hospitalization
• Patient Age: 53 YR
• Patient Weight: 140