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

Model Number 106524INT

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

Patient Problems Hematoma (1884); Respiratory Failure (2484)

Event Date 06/18/2022

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that on (b)(6) 2022, the patient was hospitalized for pneumonia.During this admission, the patient's hemoglobin dropped and a large hematoma was observed in the patient's right upper limb.An x-ray was performed which ruled out a fracture of the limb.The patient received 4 units of packed red blood cells.

Manufacturer Narrative

Manufacturer's investigation conclusion: a direct correlation between the reported bleeding and heartmate 3 left ventricular assist system (lvas), serial number (b)(6), cannot be conclusively determined through this evaluation.The relevant sections of the device history records were reviewed and showed no deviation from manufacturing or quality assurance specifications.Review of the sterilization and packaging documentation showed no deviation from manufacturing specifications.The heartmate 3 lvas instructions for use (ifu), rev.G, contains the following information: section 1 lists bleeding as an adverse event that may be associated with the use of heartmate 3 left ventricular assist system.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 (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: bob fryc ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528204
• MDR Report Key: 15000655
• MDR Text Key: 295785954
• Report Number: 2916596-2022-11923
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Reporter Country Code: EZ
• PMA/PMN Number: P160054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/28/2022
• Device Model Number: 106524INT
• Device Lot Number: 7727340
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/04/2020
• 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: 63 YR
• Patient Sex: Male
• Patient Weight: 91 KG