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

Model Number 106524US

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

Patient Problems Edema (1820); Erythema (1840); Hemorrhage/Bleeding (1888); Blood Loss (2597)

Event Date 08/31/2020

Event Type  Injury  

Manufacturer Narrative

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 on (b)(6) 2020 for fluid overload and decreased hemoglobin (hgb).The patient also noted to have some erythema around the driveline.The patient diuresed on lasix drip for fluid overload.Gastroenterology (gi) consulted for melena, planned for tagged red blood cells (rbcs) study.Study completed (b)(6) 2020 with no acute findings.Resumed coumadin (b)(6) 2020.Plan for international normalized ratio (inr) to trend up slowly without bridge.Intravenous (iv) iron replacement given and the patient was able to discharge home on (b)(6) 2020.No further information was provided.

Manufacturer Narrative

Manufacturer's investigation conclusion: a direct correlation between heartmate 3 left ventricular assist system (lvas), serial number mlp-012780, and the reported gastrointestinal (gi) bleeding, fluid overload, and erythema could not be conclusively determined through this evaluation.It was reported that the patient was admitted on (b)(6) 2020 for fluid overload and decreased hemoglobin.Erythema was also noted around the driveline.The fluid overload was treated with medication for diuresis.Melena was also reported, and a tagged red blood cell study was completed on (b)(6) 2020 with no acute findings.Anticoagulation medication was resumed on (b)(6) 2020 and an intravenous (iv) iron replacement was given.The plan was to trend the patient¿s international normalized ratio (inr) up slowly, and the patient was discharged home on (b)(6) 2020.The patient ultimately expired on 12feb2021 after declining intravenous (iv) antibiotics for an infection, and voluntarily turning the left ventricular assist device (lvad) off after a period of declining health in home hospice (refer to manufacturer report number 2916596-2021-01014).The heartmate 3 left ventricular assist system (lvas) instructions for use (ifu), rev.C is currently available.Section 1 of this document lists bleeding as 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 in the event that there is a risk of bleeding.The relevant sections of the device history records for mlp-012780 were reviewed and showed no deviations from manufacturing or quality assurance specifications.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
• MDR Report Key: 11017098
• MDR Text Key: 221770464
• Report Number: 2916596-2020-05946
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024013297
• UDI-Public: 00813024013297
• Combination Product (y/n): N
• PMA/PMN Number: P160054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 02/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/26/2021
• Device Model Number: 106524US
• Device Catalogue Number: 106524US
• Device Lot Number: 6693729
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 70 YR
• Patient Weight: 89