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

Model Number 106524US

Device Problems Electromagnetic Interference (1194); Infusion or Flow Problem (2964)

Patient Problems Arrhythmia (1721); Tachycardia (2095)

Event Date 12/29/2021

Event Type  Injury  

Event Description

It was reported that the patient was undergoing external shocks due to rhythm issues.Pump speed was previously adjusted from 5200 to 5000 but the low speed limit was left at 5000.Healthcare providers were unable to load the patient's event history.Review of the event log file from (b)(6) 2021 14:28 to (b)(6) 2021 8:333 found no low flow events or pulsatility index (pi) events although the site noted some low flow alarms.A few low speed advisory events were also noted but were attributed to the reported speed adjustments.Additional information was received that the patient had sinus tachycardia related to their subcutaneous (sq) automatic implantable cardioverter defibrillators (aicd) interacting with their left ventricular assist device (lvad).This lead to ventricular fibrillation and several external shocks.The patient's sq aicd was turned off as of (b)(6) 2022.Vector testing performed on (b)(6) 2022 found significant noise in all vectors and no reprograming options for the sq aicd.It was noted that the patient would need a transvenous icd prior to discharge.

Manufacturer Narrative

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

Manufacturer Narrative

Manufacturer's investigation conclusion: a direct correlation between heartmate 3 left ventricular assist system (lvas), serial number (b)(6) , and the report of cardiac arrhythmia and interference with a subcutaneous implantable cardioverter defibrillator (icd) could not be conclusively established through this evaluation.The submitted log files collectively contained data from (b)(6) 2021 through (b)(6) 2021 and found that the pump operated at the set speed without issue.The system appeared to be operating as intended, and there were no notable alarms active in the log files.The patient remains ongoing on (b)(6) with no further reported issues at this time.The heartmate 3 left ventricular assist system (lvas) instructions for use (ifu), rev.C, is currently available.Section 1 ¿introduction¿ of this document lists cardiac arrhythmia as an adverse event that may be associated with the use of the heartmate 3 lvas.Additionally, section 6 ¿patient care and management¿ lists arrhythmia as a potential late postimplant complication that may be associated with the use of heartmate 3 lvas.The ifu contains warnings in the introduction, surgical procedures, and patient care and management sections that that the pump may cause interference 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 hm3 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.The relevant sections of the device history records for (b)(6) were reviewed and showed no deviations from manufacturing or quality assurance specifications.The implant kit was shipped on 28oct2021.No further information was provided.The manufacturer is closing the file on this event.

Event Description

Additional information was received on 26jan2022 that the patient was stable and had no further arrhythmias.A new icd had not yet been implanted but there were plans to do so within the next few weeks.

• 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: 13337920
• MDR Text Key: 287005751
• Report Number: 2916596-2022-00149
• 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,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 03/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/17/2023
• Device Model Number: 106524US
• Device Catalogue Number: 106524US
• Device Lot Number: 8179872
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/14/2021
• 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): Required Intervention; Hospitalization
• Patient Age: 40 YR
• Patient Sex: Female
• Patient Weight: 90 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American