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

Model Number 106524US

Device Problems Infusion or Flow Problem (2964); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Tachycardia (2095); Ventricular Tachycardia (2132)

Event Date 12/16/2020

Event Type  Injury  

Manufacturer Narrative

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 patient was having ventricular tachycardia and was to have a radioablation procedure on (b)(6) 2021.This arrhythmia reportedly caused low flows on the vad.The patient was also scheduled to have radiation therapy on tissue adjacent to the pump motor, which would result in the motor receiving 15-25 grays (gy) of ionizing radiation.The physicians were concerned with the sensors in the motor being affected by this level.An abbott clinical specialist spoke with the site engineer and cautioned that the electrical components of the pump would be affected by any degree of radiation and that the effects on the lifetime of the device needed to be taken into account.It was also communicated that if there would be interference during the radiation procedure the pump should re-start upon cessation of the treatment.

Manufacturer Narrative

Manufacturer's investigation conclusion: a direct correlation between heartmate (hm) 3 left ventricular assist system (lvas), serial number (b)(6) , and the reported events could not be conclusively determined through this evaluation.Additionally, the report of low flow alarms could not be confirmed as no log files were provided by the account for review.Although a specific cause for these events could not be conclusively determined through this evaluation, the account reported that the alarms were caused as a result of the patient¿s arrhythmia.The account reported that the patient was having ventricular tachycardia (vtach) and was scheduled to have a radio ablation procedure on (b)(6)2021.Per the medical physicist, the patient was supposed to receive radiation therapy; however, due to the location, the therapy would result in the pump motor receiving a high dose of radiation.Concern was expressed for the sensors within the motor and the potential risks that could be associated with the therapy.The vad engineers cautioned that electrical components would be affected by any degree of radiation and the lifetime of the device needed to be considered.The engineers further stated that the risk of not performing the radiation therapy vs.The risk of the effect on the product life needed to be assessed.The account reported that the patient¿s arrhythmia resulted in low flow alarms.The plan was to move forward with the radiation therapy and treatment would be assessed following the procedure; however, information later communicated by the account stated that the procedure was not performed.The patient remains ongoing on heartmate 3 lvas, serial number (b)(6), and no further 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 implant kit was shipped on (b)(6) 2019.The heartmate 3 lvas instructions for use (ifu) and the heartmate 3 lvas patient handbook, are currently available.Section 1 of the ifu, ¿introduction¿, lists cardiac arrhythmia as a potential adverse event that may be associated with the use of the heartmate 3 left ventricular assist system.Section 6 of the ifu, ¿patient care and management¿, also lists arrhythmia as a potential late postimplant complication.Section 1 of the ifu also addresses all pump parameters, including pump flow.Section 4, ¿system monitor¿, describes the pump flow display and the hazard alarms.This ifu states that the low flow hazard alarm will be triggered when pump flow is less than 2.5 lpm and explains that changes in patient conditions, such as hypertension, can result in low flow.Furthermore, section 5 of the patient handbook, "alarms and troubleshooting", and section 7 of the ifu, "alarms and troubleshooting", address all system alarm conditions as well as the appropriate actions associated with each condition.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: HEARTMATE 3 LVAS IMPLANT KIT
• Type of Device: VENTRICULAR (ASSISST) BYPASS
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• MDR Report Key: 11116199
• MDR Text Key: 225049461
• Report Number: 2916596-2020-06432
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024013297
• UDI-Public: 00813024013297
• Combination Product (y/n): N
• PMA/PMN Number: P160054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 04/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/30/2022
• Device Model Number: 106524US
• Device Catalogue Number: 106524US
• Device Lot Number: 7091541
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 55 YR
• Patient Weight: 68