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

Model Number 106524US

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

Patient Problems Arrhythmia (1721); Dysphagia/ Odynophagia (1815); Pleural Effusion (2010); Heart Failure/Congestive Heart Failure (4446)

Event Date 05/17/2022

Event Type  Injury  

Manufacturer Narrative

Manufacturer's investigation conclusion: a direct correlation between heartmate (hm) 3 left ventricular assist system (lvas), serial number (b)(4), and the reported events could not be conclusively determined through this evaluation.Multiple attempts were made to obtain additional information from the customer regarding the event; however, no additional information was provided.The patient remains ongoing on hm3 lvas, serial number (b)(4), and no further events have been reported at this time.The heartmate 3 lvas ifu, rev.C, is currently available.The ifu, ¿introduction¿, lists potential adverse events, including cardiac arrhythmia and right heart failure, that may be associated with the use of the heartmate 3 left ventricular assist system.The ifu, ¿patient care and management¿, lists arrhythmia as a potential late postimplant complication.The relevant sections of the device history records for (b)(4) were reviewed and showed no deviations from manufacturing or quality assurance specifications.The implant kit was shipped on 26apr2022.No further information was provided.The manufacturer is closing the file on this event.

Event Description

It was reported that the patient fibrillated and was cardioverted during surgery.The arrhythmia occurred after sternotomy but prior to device implant.Cardiopulmonary bypass (cpb) was initiated before further manipulation of the left ventricle due to the patient's history of ventricular tachycardia (vt) and irritable myocardium.Following left ventricular assist device (lvad) implant the patient was cardioverted three times due to vt.Lvad speed was decreased, cardiac resynchronization therapy defibrillator (crtd) was interrogated, and an amiodarone bolus was given.Of note, the patient had a history of ventricular tachycardia, atrial fibrillation and atrial flutter prior to implant.Additional information was received that a chest x-ray on 21may2022 showed bilateral pleural effusions and probable atelectasis.A swallow study showed mild dysphagia due to weakness from debility and intubation.It was noted that the patient had a history of pulmonary hypertension and right side lung cancer.Post radiation the patient was having increased oxygen demands.It was also noted that as of (b)(6) 2022, the patient remained on inotropes since lvad placement, indicating right heart failure.

Event Description

Additional information: it was reported that the arrhythmias resolved on (b)(6) 2022.Dobutamine was discontinued on (b)(6) 2022 and milrinone was discontinued on (b)(6) 2022.Right heart failure and respiratory failure resolved on (b)(6) 2022 without sequalae.

Manufacturer Narrative

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 (ASSIST) 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: 14688466
• MDR Text Key: 294596920
• Report Number: 2916596-2022-11492
• 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: Study,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/15/2024
• Device Model Number: 106524US
• Device Catalogue Number: 106524US
• Device Lot Number: 8426382
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/25/2022
• Initial Date FDA Received: 06/14/2022
• Supplement Dates Manufacturer Received: 10/17/2022
• Supplement Dates FDA Received: 11/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/12/2022
• 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: 70 YR
• Patient Sex: Male
• Patient Weight: 106 KG
• Patient Race: White