MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE II; LEFT VENTRICULAR ASSIST DEVICE

Device Problems Insufficient Flow or Under Infusion (2182); Obstruction of Flow (2423)

Patient Problem Obstruction/Occlusion (2422)

Event Date 07/17/2020

Event Type  Injury  

Event Description

On (b)(6) 2020 pt at home with low flow alarms.Changed controller with continued low flow alarms.On (b)(6) called lvad office and was optimized on blood pressure meds.Ct scan scheduled for (b)(6) indicated 80% occlusion of outflow graft.Pt's inr range 2-3 subtheraputic 2 times since february.Ldh, ast, alt and t-bili all within normal range.Heart transplant performed (b)(6) 2020.

• Brand Name: HEARTMATE II
• Type of Device: LEFT VENTRICULAR ASSIST DEVICE
• Manufacturer (Section D): THORATEC CORPORATION ; 6035 stoneridge dr.; pleasanton CA 94588
• MDR Report Key: 11581393
• MDR Text Key: 242997693
• Report Number: 11581393
• Device Sequence Number: 1
• Product Code: DSQ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 11/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/27/2020
• Distributor Facility Aware Date: 07/17/2020
• Device Age: 3 YR
• Event Location: Home
• Date Report to Manufacturer: 11/27/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR
• Patient Weight: 118