MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM; VENTRICULAR (ASSISST) BYPASS

Model Number 106524

Device Problems Electromagnetic Interference (1194); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Tachycardia (2095)

Event Date 07/01/2021

Event Type  Injury  

Manufacturer Narrative

Specific patient information and device serial number were documented as 'unknown'.The date of the event has been entered as the same as published date ((b)(6) 2021) since date of data collection was not provided.The author of the article was provided as follows: sabbag a, et al.Annual congress of the european heart rhythm association, ehra 2021.; (b)(6) center, (b)(6) institute, (b)(6) and center (b)(6), (b)(6).No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is completed.

Event Description

It was reported that the heartmate 3 may be related to ventricular tachycardia and electromagnetic interface.This was reported through the research abstract "heartmate 3- challenges in ventricular tachycardia ablation".This was a cohort study, which included 19 patient's implanted with a heartmate 3.A total of 53% of the patient's presented with ventricular tachycardia, and severe electromagnetic interference was present in the surface electrocardiogram.

Manufacturer Narrative

Specific patient information and device serial number were documented as 'unknown'.The date of the event has been entered as the same as published date (july 2021) since date of data collection was not provided.The author of the article was provided as follows: sabbag a, et al.Annual congress of the european heart rhythm association, ehra 2021.; sheba medical center, sheba medical institute, ramat gan, israel and center for experimental cardiovascular research, prague, czechia.No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is completed.

Event Description

It was reported that the heartmate 3 may be related to ventricular tachycardia and electromagnetic interface.This was reported through the research abstract "heartmate 3- challenges in ventricular tachycardia ablation".This was a cohort study, which included 19 patient's implanted with a heartmate 3.A total of 53% of the patient's presented with ventricular tachycardia, and severe electromagnetic interference was present in the surface electrocardiogram.

Manufacturer Narrative

Manufacturer's investigation conclusion: a direct correlation between the device and the reported events could not be conclusively determined through this evaluation.The research abstract, ¿heartmate 3-challenges in ventricular tachycardia ablation,¿ outlines the challenges associated with ventricular tachycardia ablation (vta) for patients implanted with heartmate 3 lvas due to the pump's magnetic properties.This was a cohort study, which included 19 patient's implanted with a heartmate 3 who presented with vt (53% with storm vt).Severe electromagnetic interference was present in the surface electrocardiogram (ecg).The abstract concluded that vta in patients with heartmate 3 is feasible and safe when done in the appropriate setup.The study referenced in the article consisted of 19 heartmate 3 left ventricular assist (lvas) patients; therefore, the specific device and other case/patient information is not available, and was not requested.No product was evaluated.The heartmate 3 left ventricular assist system (lvas) instructions for use (ifu) is currently available.The introduction section of this document lists cardiac arrhythmia as an adverse event that may be associated with the use of heartmate 3 lvas.The patient care and management section also lists arrhythmia as a potential late postimplant complication.This document also contains warnings in the introduction, surgical procedures, and patient care and management sections that the pump may cause interference, specifically with icds (implantable cardioverter defibrillators).If electromagnetic interference occurs it may lead to inappropriate icd therapy.The occurrence of electromagnetic interference with icd sensing may require adjustment of device sensitivity and/or repositioning the lead.Prior to implanting an icd or ipm (implantable pacemaker) in an hm3 patient, the device to be implanted should be placed in close proximity to the hm3 pump and the telemetry verified.If the patient received a heartmate 3 and has a previously implanted device that is found to be susceptible to programming interference, the manufacturer recommends replacing the icd device with one that is not prone to programming interference.The safety testing and classification section of the ifu states that if the heartmate 3 lvas does cause interference to another device, the user is encouraged to try to correct the interference by reorienting or relocating the equipment, increase the separation between the equipment, connect the equipment to an outlet on a circuit different from that to which other devices are connected, or contact the manufacturer for assistance.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM
• 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: 13057162
• MDR Text Key: 285969819
• Report Number: 2916596-2021-07286
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024013297
• UDI-Public: 813024013297
• Combination Product (y/n): N
• Reporter Country Code: EZ
• PMA/PMN Number: P160054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 02/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 106524
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Other