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 Abdominal Pain (1685); Pain (1994)

Event Date 06/16/2022

Event Type  Injury  

Event Description

It was reported that the patient pulled their driveline which caused some serosanguinous drainage and abdominal pain.

Manufacturer Narrative

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

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported event could not be confirmed through this evaluation.The patient remains ongoing on heartmate 3 left ventricular assist system (lvas).No further events have been reported at this time.Although no infection was confirmed, the heartmate 3 lvas instructions for use (ifu) lists infection as an adverse event which may be associated with the use of heartmate 3 lvas.This document cautions the user to avoid pulling on or moving the driveline as it can cause trauma or tissue damage.Both the ifu and patient handbook outline all care instructions for driveline and driveline exit site.The relevant sections of the device history records were reviewed and showed no deviations from manufacturing or quality assurance specifications.The heartmate 3 lvas instructions for use (ifu) is currently available.Section 1, "introduction," lists infection as an adverse event which may be associated with the use of heartmate 3 lvas.Section 6, "patient care management," includes a subsection titled "caring for the driveline exit site" which outlines considerations for driveline care.The heartmate 3 lvas patient handbook is also currently available.Section 4, "living with the heartmate 3," cautions the user to avoid pulling on or moving the driveline as it can cause trauma or tissue damage.This section also provides care instructions for driveline exit site care.No further information was provided.The manufacturer is closing the file on this event.

Event Description

No cultures were taken.The patient was treated with keflex.The patient would continue on keflex and the driveline exit site would be monitored.

• 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: 14945741
• MDR Text Key: 295421840
• Report Number: 2916596-2022-11901
• 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
• Report Date: 09/26/2022

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: 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: 09/23/2022
• 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): Other
• Patient Age: 32 YR
• Patient Sex: Male
• Patient Weight: 133 KG