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

Model Number 106524US

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

Patient Problems Atrial Fibrillation (1729); Pleural Effusion (2010); Tachycardia (2095)

Event Date 07/06/2021

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 experienced a implantable cardioverter-defibrillator (icd) shock for atrial fibrillation with rapid ventricular response on (b)(6) 2021.The patient had a history of these issues and was started on amiodarone by drops.Cardioversion was also done and the patient was stable at the time.The patient experienced bilateral pleural effusions which were seen in chest x-ray on (b)(6) 2021.They had a moderate left and a small right pleural effusion.The patient remained in ongoing/stable condition.

Event Description

The patient's rapid ventricular response deteriorated into ventricular tachycardia.The patient was noted to have atrial fibrillation and implantable cardioverter-defibrillator prior to left ventricular assist device.The patient was discharged on (b)(6) 2021 on amiodarone 200 milligrams per day.An electrocardiogram on (b)(6) 2021 showed that the patient was in v-paced rhythm and biventricular pacemaker was detected.No further events were noted.

Manufacturer Narrative

Manufacturer's investigation conclusion: a direct correlation between the device and the reported cardiac arrhythmia and pleural effusions could not be conclusively established through this investigation.The patient remains ongoing on heartmate (hm) 3 left ventricular assist system (lvas), serial number (b)(6).No product is available for investigation.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) 2021.The heartmate 3 left ventricular assist system instructions for use lists cardiac arrhythmia as an adverse event, as well as a potential late postimplant complication that may be associated with the use of the heartmate 3 left ventricular assist system.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: 12288845
• MDR Text Key: 265420438
• Report Number: 2916596-2021-04209
• 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: company representative,health
• Type of Report: Initial,Followup
• Report Date: 10/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/05/2022
• Device Model Number: 106524US
• Device Catalogue Number: 106524US
• Device Lot Number: 8000642
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 67 YR
• Patient Weight: 90