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 Bacterial Infection (1735); Purulent Discharge (1812); Nausea (1970); Vomiting (2144)

Event Date 05/13/2022

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 had a major driveline infection.This occured when the patient's dog accidentally tugged on their driveline and part of it came out of the wound site.Patient was started on doxycycline (acticlate) on (b)(6) 2022.The patient presented to emergency care (ec) on (b)(6) 2022.Blood and wound drainage cultures were performed on (b)(6) 2022.Although the blood cultures were negative for growth, wound drainage cultures were positive for a rare gram postive cocci in pairs and isolated staphylococcus.The patient received vancomycin (vancocin) and cefepime (maxipime).The patient had nausea and intermittent billious vomiting every other day for at least one month prior to admission.

Manufacturer Narrative

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

Event Description

The patient was discharged on (b)(6) 2022 one an 8 day course of linezoid (zyvox).

Manufacturer Narrative

Manufacturer's investigation conclusion: a specific cause for the patient¿s driveline infection could not be conclusively determined through this evaluation.Additionally, a direct correlation between heartmate (hm) 3 left ventricular assist system (lvas), serial number (b)(6), and the reported gastroparesis could not be conclusively established.The account also reported that visual inspection of the patient¿s driveline site showed improvement and the event was considered to be resolved.The patient remains ongoing on heartmate 3 lvas, serial number (b)(6).The heartmate 3 lvas ifu, rev.C, and the heartmate 3 patient handbook, rev.D, are currently available.Section 1 of the ifu, ¿introduction¿, lists potential adverse events, including infection (local, driveline, pump pocket), that may be associated with the use of the heartmate 3 left ventricular assist system.Section 6 of the ifu, ¿patient care and management¿, also lists infection as a potential late postimplant complication.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.The relevant sections of the device history records for (b)(6) were reviewed and showed no deviations from manufacturing or quality assurance specifications.Review of the sterilization and packaging documentation in the device history records found no deviations from manufacturing specifications.The implant kit was shipped on 06may2021.No further information was provided.The manufacturer is closing the file on this event.

Event Description

The patient stated that the driveline was pulled about a week prior to (b)(6) 2022.The exact event date has been estimated.The patient's nausea and vomiting were due to gastroparesis which was determined to not be device related.

• 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: 14604604
• MDR Text Key: 293377351
• Report Number: 2916596-2022-11303
• 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,Followup,Followup
• Report Date: 07/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/10/2022
• Device Model Number: 106524US
• Device Catalogue Number: 106524US
• Device Lot Number: 7888701
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/17/2021
• 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): Life Threatening; Hospitalization; Required Intervention
• Patient Age: 52 YR
• Patient Sex: Female
• Patient Weight: 92 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American