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 Hemorrhage, Subdural (1894); Weakness (2145)

Event Date 02/24/2020

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 underwent a head computed tomography (ct) scan on (b)(6) 2020.The head ct showed small subacute subdural hemorrhage.The patient had right-sided weakness.The patient's international normalized ratio (inr) was 2.9.The patient was on coumadin and aspirin.No surgical intervention was required.The patient's blood pressure was appropriately managed.As of (b)(6)2020, the patient had no residual effects from the stroke.The patient had right-sided weakness and confusion.A ct was obtained.The patient had an international normalized ratio (inr) of 2.9 at the time of the bleed.Fresh frozen plasma was given to reverse inr.Subdural was reabsorbed.The patient had no deficits.

Manufacturer Narrative

Section b2: additional information.Manufacturer's investigation conclusion: a specific cause for the reported events, as well as a direct correlation to the heartmate 3 lvas, serial number (b)(6), could not conclusively be determined through this evaluation.The relevant sections of the device history records for (b)(6), were reviewed and showed no deviations from manufacturing or quality assurance specifications.The pump was shipped on (b)(6) 2020.The heartmate 3 lvas ifu lists bleeding and stroke as adverse events that may be associated with the use of the heartmate 3 left ventricular assist system.No further information was provided.The manufacturer is closing this event.

• Brand Name: HEARTMATE 3 LVAS IMPLANT KIT
• Type of Device: VENTRICULAR (ASSISST) BYPASS
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• MDR Report Key: 10817812
• MDR Text Key: 215552673
• Report Number: 2916596-2020-05469
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024013297
• UDI-Public: 00813024013297
• Combination Product (y/n): N
• PMA/PMN Number: P160054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 11/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/20/2022
• Device Model Number: 106524US
• Device Catalogue Number: 106524US
• Device Lot Number: 7341857
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 66 YR
• Patient Weight: 68