MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE 3 LVAS IMPLANT KIT; VENTRICULAR (ASSISST) BYPASS

Model Number 106524US

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Stroke/CVA (1770); Hemorrhage, Subdural (1894)

Event Date 10/14/2020

Event Type  Injury  

Manufacturer Narrative

Manufacturer's investigation conclusion: the pump remains in use supporting the patient.A correlation between the device and the report of stroke could not be conclusively determined.Stroke is listed in the instructions for use as a potential adverse event that may be associated with the use of heartmate 3 left ventricular assist system.Stroke has been previously investigated and will continue to be monitored through quality data reviews, which are conducted on production and post product signals to evaluate if products are conforming to product requirements.No further information was provided.The manufacturer is closing the file on this event.No further information was provided.The manufacturer is closing the file on this event.

Event Description

It was reported that ct scan revealed the patient had a subdural bleed.He was admitted in the beginning of (b)(6) for transient ischemic attack (tia) after he had sub-therapeutic inr for one week.On (b)(6) 2020 the patient initially did not take coumadin or lovenox until the next day.On (b)(6) 2020, the patient reported migraine at night, specifically a sinus headache behind the left eye.Tylenol provided some relief, but there was vomiting.On (b)(6) 2020 the patient had symptoms of slurred speech, stumbling on words.The patient had a seizure and exhibited expressive aphasia.Craniotomy with evacuation of bilateral subdural hematomas was performed the next day.The patient remained at (b)(6) hospital in (b)(6) with therapeutic inr.

• Brand Name: HEARTMATE 3 LVAS IMPLANT KIT
• Type of Device: VENTRICULAR (ASSISST) 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: 10762784
• MDR Text Key: 213893528
• Report Number: 2916596-2020-05263
• 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: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/20/2022
• Device Model Number: 106524US
• Device Catalogue Number: 106524US
• Device Lot Number: 7336450
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/14/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/09/2020
• 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; Required Intervention
• Patient Age: 48 YR
• Patient Weight: 96