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 Problems Tachycardia (2095); Ventricular Tachycardia (2132)

Event Date 11/27/2020

Event Type  Injury  

Manufacturer Narrative

The heartmate 3 lvas was implanted during the (b)(6) clinical trial, ide# (b)(4).Fda approval for heartmate 3 lvas was received on 23 august 2017.The same device is used commercially and in the ongoing (b)(6) trial.The gtin unique device identifier for the commercial heartmate3 lvas is (b)(4).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 vad coordinator (vc) reported to the clinician that the patient was complaining of feeling palpitations that correlated with the "the wash out/pulsatility of the heartmate 3." the vc noted that while auscultating, the vibration feeling that the patient reported appeared to correspond with the "wash out/pulsatility" of the pump.The clinical recommended sending log files to be reviewed.The vc also reported the potential need to ensure proper pump positioning with imaging as well as investigating lack of interference from the patient's implantable cardioverter-defibrillator (icd).Per the vc, the pump appears to be operating without any issues and the patient is clinically stable at home.It was additionally reported on 14dec2020 that when the customer referred to the washout/pulsatility of the pump, they were referring to the occurrence of pump speed changes.No images have been acquired to rule out improper positioning of the pump and no interference between the implantable cardioverter-defibrillator (icd) and the lvad system has been confirmed.The patient did receive a shock from their icd during this event.It was additionally reported that the patient's icd was implanted prior to vad to treat ventricular tachycardia.

Manufacturer Narrative

Manufacturer's investigation conclusion: a direct correlation between heartmate 3 left ventricular assist system (lvas), serial number (b)(6), and the reported event could not conclusively be established through this evaluation.Furthermore, a specific cause for the event could not be determined.The patient remains ongoing on heartmate 3 lvas, serial number (b)(6).No further related events have been reported at this time.The relevant sections of the device history records for (b)(6) were reviewed and showed no deviations from manufacturing or quality assurance specifications.The relevant sections of the device history records for the percutaneous lead were also reviewed and showed no deviations from manufacturing or quality assurance specifications.The implant kit was shipped on 22jun2017.The heartmate 3 left ventricular assist system (lvas) instructions for use (ifu) is currently available.Section 1 of this document lists cardiac arrhythmia as an adverse event that may be associated with the use of the heartmate 3 lvas.Section 6 entitled ¿patient care and management¿ also lists arrhythmia as a potential late postimplant complication.Section 1, ¿introduction¿, and section 6, ¿patient care and management¿, instruct the user to notify appropriate personnel if there is a change in how the pump works, sounds, or feels.Section 5 "surgical procedures" explains how to insert the pump in the ventricle and instructs the user to take care to avoid orienting the inlet towards the interventricular septum as pump function will be compromised in the presence of inlet obstruction.The steps to adjust the orientation of the pump are also outlined in this section.Section 1 "introduction", section 5 "surgical procedures", and section 6 "patient care and management" warn the user: the heartmate iii pump may cause interference with automated implantable cardioverter defibrillators (aicds).If electromagnetic interference occurs it may lead to inappropriate aicd therapy.The occurrence of electromagnetic interference with aicd sensing may require adjustment of device sensitivity and/or repositioning the lead." sections 5 and 6 additionally warns the user: prior to implanting an implantable cardiac defibrillator (icd) or implantable pacemaker (ipm) in a heartmate iii patient, the device to be implanted should be placed in close proximity to the pump (approximately 10 cm) and the telemetry verified.If a patient receives a heartmate iii and has a previously implanted device that is found to be susceptible to electromagnetic interference which could affect programming, the manufacturer recommends replacing the icd or ipm device with one that is not prone to programming interference.Section b "safety testing and classification" states: the heartmate iii left ventricular assist system has been tested and found to comply with the limits for medical devices to the international electrotechnical commission (iec).These limits are designed to provide reasonable protection against harmful interference in a typical medical installation.The heartmate iii left ventricular assist system can generate, use, and radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to other devices in the vicinity.However, there is no guarantee that interference will not occur in a particular installation.If this equipment does cause harmful interference to other devices, the user is encouraged to try to correct the interference by one or more of the following measures: reorient or relocate the equipment, increase the separation between the equipment, connect the equipment into an outlet on a circuit different from that to which the other device(s) are connected, consult the manufacturer for assistance.Note: special precautions are required for installing and using the heartmate iii left ventricular assist system within portable and rf communication environments.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
• MDR Report Key: 11055730
• MDR Text Key: 229609086
• Report Number: 2916596-2020-06074
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• PMA/PMN Number: P160054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 03/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/31/2020
• Device Model Number: 106524
• Device Lot Number: 6036878
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 54 YR
• Patient Weight: 105