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

Model Number 106524US

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

Patient Problems Chest Pain (1776); Unspecified Infection (1930)

Event Date 05/12/2022

Event Type  Injury  

Manufacturer Narrative

Manufacturer's investigation conclusion: a direct correlation between heartmate 3 (hm3) left ventricular assist system (lvas), serial number (b)(4), and the reported events could not be conclusively established through this evaluation.Multiple attempts were made to obtain additional information from the customer regarding the event; however, no additional information was provided.The patient remains ongoing on heartmate 3 lvas, serial number (b)(4).No product is available for investigation.The relevant sections of the device history records for (b)(4) were reviewed and showed no deviations from manufacturing or quality assurance specifications.The implant kit was shipped on (b)(6) 2022.The heartmate 3 lvas instructions for use (ifu), rev.C and the heartmate 3 lvas patient handbook, rev.D are currently available.Section 1 of the ifu, ¿introduction¿, lists adverse events such as infection (local, driveline, and pump pocket), that may be associated with the use of the heartmate 3 lvas.The ifu provides information regarding anticoagulation, including the recommended inr values.Section 6 of the ifu, ¿patient care and management¿, also lists infection as a potential late postimplant complication.Furthermore, several sections of the hm3 ifu and patient handbook provide care instructions regarding how to prevent infection as well as suggested responses in the event of infection.No further information was provided.The manufacturer is closing the file on this event.

Event Description

It was reported that the patient had sternal pain and increased green and white drainage from their subxiphoid wound.

• 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: 14949793
• MDR Text Key: 295475956
• Report Number: 2916596-2022-11765
• 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,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/15/2023
• Device Model Number: 106524US
• Device Catalogue Number: 106524US
• Device Lot Number: 8253022
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/07/2021
• 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: 44 YR
• Patient Sex: Female
• Patient Weight: 115 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American