MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE II LVAS IMPLANT KIT (WITH SEALED GRAFTS); VENTRICULAR (ASSISST) BYPASS

Model Number 106015

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

Patient Problems Hemorrhage, Cerebral (1889); Blood Loss (2597)

Event Date 04/15/2019

Event Type  Injury  

Manufacturer Narrative

Manufacturer's investigation conclusion: a specific cause for the reported subdural hematoma, as well as a direct correlation to heartmate ii left ventricular assist device (lvas), serial number (b)(4), could not be conclusively determined through this evaluation.The patient remains ongoing on (b)(4) with no further related issues at this time.The relevant sections of the device history records for (b)(4) were reviewed and showed no deviations from manufacturing or quality assurance specifications.The heartmate ii lvas instructions for use (ifu) lists stroke, neurologic dysfunction, and bleeding as adverse events that may be associated with the use of the heartmate ii left ventricular assist system.This ifu also outlines the recommended anticoagulation therapy and inr range.No further information was provided.The manufacturer is closing the file on this event.

Event Description

It was reported that the patient had acute worsening of weakness in their left arm and was relying on their walker to get around.The patient saw their primary care physician (pcp) the next day, who ordered a computed tomography (ct) scan of the patient's head on (b)(6) 2019.That ct scan revealed a right subdural hematoma and the patient was admitted to duke hospital.Originally, the patient presented with fatigue, malaise, and lower extremity weakness from (b)(6) 2020.At that time it was felt that his non specific symptoms were likely related to deconditioning and possible contribution from his interferon therapy.On admission, the patient was hemodynamically stable and conversant.In the emergency room (er) he received a repeat ct of his brain which revealed mixed age (subacute) subdural hemorrhage with midline shift.Neurosurgery was consulted and the patient underwent a right-sided craniotomy with evacuation.The patient's left-sided weakness continued to improve and anticoagulation was restarted 3 days post-op following neurosurgery approval and repeat ct scan.The midline shift remained stable on ct with therapeutic anticoagulation.Warfarin was also restarted for goal international normalized ratio (inr) 1.5-2.The patient was treated with 7 days of keppra for seizure prophylaxis and blood pressure was maintained at goal mean arterial pressure (map) <90 by starting carvedilol.The patient did not tolerate lisinopril due to dizziness.The patient developed left arm weakness later in admission; a repeat ct was unchanged and weakness improved rapidly.Neurology signed off.Physical therapy was consulted and the patient was able to ambulate and was discharged home with pt/ot and tolling walker.The patient's left-sided weakness was much improved by discharge on (b)(6) 2019.

• Brand Name: HEARTMATE II LVAS IMPLANT KIT (WITH SEALED GRAFTS)
• 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: 10949006
• MDR Text Key: 220984912
• Report Number: 2916596-2020-05782
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024011224
• UDI-Public: 00813024011224
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P060040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,study
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/30/2018
• Device Model Number: 106015
• Device Catalogue Number: 106015
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/16/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/13/2015
• 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: 77 YR
• Patient Weight: 90