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 Dyspnea (1816); Pleural Effusion (2010); Hypervolemia (2664); Skin Infection (4544)

Event Date 08/30/2022

Event Type  Injury  

Event Description

It was reported that the patient presented to an outside hospital emergency department (ed) with shortness of breath.And they were noted to be up 20 lbs from their dry weight.The patient was transferred for further management.The plan of care was to administer intravenous diuretics and reach a goal mean arterial pressure (map) of 65-85.No cause for volume overload was established.A computed tomography (ct) scan of the chest showed interval development of fluid and soft tissue thickening along the visualized course of the driveline, indicative of a driveline infection.Interval resolution of a previously noted small left-sided pleural effusion with mild residual left-sided pleural thickening was also observed.

Manufacturer Narrative

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

Event Description

Additional information: it was reported that computed tomography (ct) scan of the chest also showed no acute parenchymal lung disease and mild intrathoracic lymphadenopathy, likely reactive.

Manufacturer Narrative

Section a2: patient date of birth was inadvertently added in initial report and should have been removed due to patient privacy laws.Manufacturer's investigation conclusion: a direct correlation between heartmate (hm) 3 left ventricular assist system (lvas), serial number (b)(6), and the reported event could not be conclusively determined through this evaluation.Additionally, a specific cause for the patient's infection could not be conclusively determined.The patient remains ongoing on hm3 lvas, serial number (b)(6), and no further 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 implant kit was shipped on (b)(6) 2020.Review of the sterilization and packaging documentation in the device history records found no deviations from manufacturing specifications.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, and pump pocket), that may be associated with the use of heartmate 3 left ventricular assist system.Section 6 of the ifu, ¿patient care and management¿, lists infection as a potential late postimplant complication.Several sections of the 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.

• 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: 15508783
• MDR Text Key: 300874742
• Report Number: 2916596-2022-13915
• 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: Other,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 10/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/12/2022
• Device Model Number: 106524US
• Device Catalogue Number: 106524US
• Device Lot Number: 7513552
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/30/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/13/2020
• 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
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Weight: 100 KG