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 Pleural Effusion (2010); Gastrointestinal Hemorrhage (4476); Melena (4480)

Event Date 02/08/2022

Event Type  Injury  

Event Description

It was reported that the patient presented to the emergency department on (b)(6) 2022 after having dark, tarry stools since (b)(6) 2022.The patient had labs, x-rays, and electrocardiogram done upon admission.Chest x-ray was stable from their last study, and there was a small pleural effusion and no pneumothorax.Hemoglobin was stable at 13.9 g/dl and the patient was discharged with instructions to return if excessive bleeding from gastrointestinal tract was noted.

Manufacturer Narrative

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

Manufacturer Narrative

Manufacturer's investigation conclusion: a direct correlation between the device and the reported gastrointestinal bleeding and pleural effusion could not be conclusively determined through this evaluation.The patient remains ongoing with heartmate 3 left ventricular assist system (lvas), serial number (b)(6).No further related events have been 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 3 left ventricular assist system (lvas) instructions for use (ifu) is currently available.Section 1 ¿introduction¿ of this document lists bleeding as an adverse event that may be associated with the use of heartmate 3 lvas.Additionally, section 6 ¿patient care and management¿ provides information regarding the recommended anticoagulation therapy and inr (international normalized ratio) range, as well as considerations for when there is a risk of bleeding.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: 13752479
• MDR Text Key: 287578285
• Report Number: 2916596-2022-00990
• 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: Study,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/07/2023
• Device Model Number: 106524US
• Device Catalogue Number: 106524US
• Device Lot Number: 8027455
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/23/2021
• 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): Other
• Patient Age: 51 YR
• Patient Sex: Male
• Patient Weight: 111 KG