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

Model Number 107801

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

Patient Problems Stroke/CVA (1770); Muscle Weakness (1967); Tics/Tremor (4425)

Event Date 07/06/2022

Event Type  Injury  

Event Description

It was reported that the patient's screen was showing (---) on the flows continuously without alarming.The patient presented to the hospital with weakness and tremors.Computerized tomography (ct) revealed a possible acute right middle cerebral artery (mca) stroke.Mean arterial pressure (map) was noted to be 90-100 mmhg.The patient was euvolemic and well perfused but had poor intake by mouth.

Manufacturer Narrative

No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is complete.

Manufacturer Narrative

Manufacturer's investigation conclusion: a direct correlation between the device and the reported suspected acute right middle cerebral artery (mca) stroke could not be conclusively established through this evaluation.The submitted log file contained data from 14apr2022 through 06jul2022.Several flow estimator low limit exceeded faults which would have resulted in the "---" symbols being displayed on the system controller were captured per design to prevent the display of potentially inaccurate flow information; however, no low flow events or alarms were observed.The pump appeared to be functioning as intended, remaining above the low speed limit for the duration of the file.Multiple attempts were made to obtain additional information from the customer regarding the event; however, no additional information was provided.The patient remains ongoing on heartmate ii left ventricular assist system (lvas).No product is available for investigation.The heartmate ii lvas instructions for use (ifu) lists stroke as an adverse event which may be associated with the use of heartmate ii lvas and provides the recommended anticoagulation regimen, including international normalized ratio (inr) range, as well as suggested anticoagulation modifications.This document also explains that "if the flow estimate falls outside the expected operational range or acceptable linear region, the pump flow box displays '+++' or '---'.This prevents the display of inaccurate flow information." the relevant sections of the device history records were reviewed and showed no deviations from manufacturing or quality assurance specifications.The heartmate ii left ventricular assist system (lvas) instructions for use (ifu) is currently available.Section 1, "introduction," lists stroke as an adverse event which may be associated with the use of heartmate ii lvas.Section 4 "system monitor" explains that "if the flow estimate falls outside the expected operational range or acceptable linear region, the pump flow box displays "+++" or "- - -".This prevents the display of inaccurate flow information." section 6, ¿patient care and management¿ (under ¿anticoagulation¿), provides the recommended anticoagulation regimen, including international normalized ratio (inr) range, as well as suggested anticoagulation modifications.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: HEARTMATE II LVAS IMPLANT KIT
• Type of Device: VENTRICULAR (ASSIST) 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: 15106044
• MDR Text Key: 296614313
• Report Number: 2916596-2022-12302
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024011996
• UDI-Public: 00813024011996
• 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,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 09/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/28/2021
• Device Model Number: 107801
• Device Catalogue Number: 107801
• Device Lot Number: 6536306
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/11/2018
• 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): Life Threatening; Hospitalization
• Patient Age: 62 YR
• Patient Sex: Male
• Patient Weight: 44 KG