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); High Blood Pressure/ Hypertension (1908); Skin Infection (4544)

Event Date 06/30/2022

Event Type  Injury  

Event Description

It was reported that the patient was admitted on (b)(6) 2022 with a suspected acute on chronic driveline infection.The patient was being treated with multiple intravenous (iv) antibiotics.Blood and driveline exit site (dles) cultures grew pseudomonas.On (b)(6) 2022 the patient was hypertensive with a blood pressure of 134/104 mmhg despite being on norvasc and losartan.There was uncertainty regarding whether or not the patient had been taking medications correctly.Routine blood pressure medication was ordered upon admission and blood pressure came down.Per computed tomography (ct), the infection appeared to be worsening.The patient remained hospitalized and incision and drainage of the driveline was being considered.

Manufacturer Narrative

Section b5: chronic driveline infection captured under mfr.Report # 2916596-2022-00288 and 2916596-2021-06662.Manufacturer's investigation conclusion: a specific cause for the reported driveline infection and hypertension as well as a direct correlation to heartmate (hm) 3 left ventricular assist system (lvas), serial number mlp-025646, could not be conclusively determined through this evaluation.The patient remains ongoing on hm3 lvas, serial number (b)(4), and no further events have been reported at this time.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 infection (local, driveline, and pump pocket) and hypertension as adverse events 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.This section also states that adequate therapy for post-implantation hypertension should consistently maintain the mean arterial blood pressure below 90 mm hg.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 the relevant sections of the device history records for mlp-025646 were reviewed and showed no deviations from manufacturing or quality assurance specifications.The implant kit was shipped on 05apr2021.Review of the sterilization and packaging documentation in the device history records found no deviations from manufacturing specifications.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: 15084224
• MDR Text Key: 296385702
• Report Number: 2916596-2022-12220
• 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
• Report Date: 07/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/19/2022
• Device Model Number: 106524US
• Device Catalogue Number: 106524US
• Device Lot Number: 7845077
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/15/2021
• 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): Hospitalization; Required Intervention
• Patient Age: 32 YR
• Patient Sex: Female
• Patient Weight: 91 KG