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 Arrhythmia (1721); Dyspnea (1816); Pleural Effusion (2010); Pulmonary Dysfunction (2019); Ventricular Fibrillation (2130); Thrombocytopenia (4431)

Event Date 12/09/2021

Event Type  Injury  

Event Description

It was reported that the patient had worsening shortness of breath over four days.The patient required 4 liters (l) of oxygen compared to their normal 2 l.The patient presented to the emergency room (er) hypoxic.The patient reportedly had a large right pleural effusion and associated lung collapse.The patient had ventricular fibrillation (vf) and received two implantable cardioverter defibrillator (icd) shocks on (b)(6) 2021.The patient received antitachycardia pacing (atp) followed by an ineffective icd shock and one more icd shock which terminated the rhythm.The patient's furosemide (lasix) drip was stopped and they were given 4 grams of magnesium, 60 meq of potassium orally, 10 meq of potassium by intravenous piggyback (ivpb), and an amiodarone drip.On (b)(6) 2021 the patient had a complete blood count (cbc) that showed thrombocytopenia which was likely due to a recent medication change.

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 (hm) 3 left ventricular assist system (lvas), serial number (b)(6) , and the reported events could not be conclusively determined through this evaluation.The patient remains ongoing on hm3 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 hm3 lvas instructions for use (ifu), rev.C, is currently available.Section 1 of the ifu lists adverse events, including respiratory failure and cardiac arrhythmia, that may be associated with the use of the heartmate 3 left ventricular assist system.Section 6 of the ifu, ¿patient care and management¿, lists arrhythmia as a potential late postimplant complication.No further information was provided.The manufacturer is closing the file on this event.

Event Description

It was reported that the ventricular assist device (vad) did not contribute to the patient's pleural effusion.The patient was admitted and treated inpatient, including undergoing thoracentesis.The patient was discharged.

• 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: 13196742
• MDR Text Key: 286540988
• Report Number: 2916596-2021-07674
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 01/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/07/2022
• Device Model Number: 106524US
• Device Catalogue Number: 106524US
• Device Lot Number: 7728260
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/05/2020
• 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; Life Threatening; Hospitalization
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Weight: 111 KG