MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE; VENTRICULAR (ASSISST) BYPASS

Model Number 105306

Device Problem Mechanical Problem (1384)

Patient Problems Thrombosis (2100); Thrombosis/Thrombus (4440)

Event Date 12/01/2020

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 may have a non-occlusive thrombus in the outflow graft on the computer tomography angiography (cta).

Manufacturer Narrative

Manufacturer's investigation conclusion: the report of a non-occlusive thrombus in the outflow graft could not be confirmed through this evaluation.It was reported that there was an incidental finding of a possible non-occlusive thrombus in the outflow graft through a computed tomography angiography (cta) scan.The submitted log file contained approximately 11 days of data.No hazard alarms were observed within the file.The pump remained above the low speed limit for the duration of the file.The pump appeared to be functioning as intended.The account later communicated that the thrombus could not be confirmed.The patient remains ongoing on heartmate ii left ventricular assist system (lvas), serial number (b)(6).No further related events have been reported at this time.The heartmate ii left ventricular assist system (lvas) instructions for use (ifu), is currently available.Section 1 of this ifu lists device thrombosis as an adverse event that may be associated with the use of the heartmate ii left ventricular assist system.This ifu outlines indications of pump thrombosis as well as how to respond to such events.Section 6 also outlines the suggested anticoagulation regimen and international normalized ratio (inr) range that should be maintained for patients using the heartmate ii lvas.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 04feb2013.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE
• Type of Device: VENTRICULAR (ASSISST) BYPASS
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• MDR Report Key: 11057018
• MDR Text Key: 223181806
• Report Number: 2916596-2020-06058
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• PMA/PMN Number: P060040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 01/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2014
• Device Model Number: 105306
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 84 YR
• Patient Weight: 79