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); Respiratory Distress (2045); Right Ventricular Dysfunction (2054)

Event Date 04/29/2020

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 patient was admitted on (b)(6) 2020 from community emergency department (ed) for incessant ventricular tachycardia (vt), for which patient's implantable cardioverter-defibrillator (icd) failed to shock him.After admit to cardiovascular intensive care unit (cvicu), direct current cardioversion (dcc) was performed and patient was returned to normal sinus rhythm (nsr).Patient underwent a right heart catheterization (rhc) on (b)(6) 2020 and discovered mod right ventricular (rv) dysfunction (unchanged from preimplant) and normal cardiac output (co) and cardiac index (ci).Due to return to vt, a bilateral sympathectomy was performed on (b)(6) 2020, but patient continued with vt post-procedure and required conversion.His amiodarone was increased.On (b)(6) 2020, patient experienced a hypoxic respiratory arrest, believed to be rv related by his care team, and was intubated (b)(6) 2020 - (b)(6) 2020.Since that event, he experienced delirium and failed swallow study.The are continuing with supportive measures.

Manufacturer Narrative

Manufacturer's investigation conclusion: a direct correlation between the device and the reported ventricular tachycardia, right ventricle dysfunction, hypoxic respiratory arrest, and neurological issues following intubation could not be determined through this evaluation.However, it was reported that the patient's right ventricle dysfunction was a preexisting condition and was unchanged from preimplant.It was reported that the patient was directly admitted on (b)(6) 2020 (approximately 4 months post-implant) from the community emergency department for incessant ventricular tachycardia (vt), for which the patient's implantable cardioverter defibrillator (icd) failed to shock him.After admission to the cardiovascular intensive care unit (cvicu), direct current conversion (dcc) was performed and the patient was returned to normal sinus rhythm (nsr).The patient underwent a right heart catheterization (rhc) on (b)(6) 2020, which revealed moderate right ventricle (rv) dysfunction with normal cardiac output (co) and cardiac index (ci).It was reported that the patient¿s rv dysfunction was unchanged from preimplant.Information provided indicated that a bilateral sympathectomy was performed on (b)(6)2020 due to recurring vt, but the patient continued to experience vt post-procedure and required conversion.His amiodarone dosage was also increased.The patient then experienced a hypoxic respiratory arrest on (b)(6) 2020, which was believed to be rv related by his care team.The patient was intubated from (b)(6) 2020.Since that event, he experienced delirium and failed a swallow study.The center continued with supportive measures.No alarms or functional issues with the lvas were reported in association with the event.The patient remains ongoing on (b)(6) and no additional events have been reported at this time.The heartmate 3 lvas ifu lists cardiac arrhythmia, right heart failure, respiratory failure, and other neurological event (not stroke-related) as adverse events 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: 10158769
• MDR Text Key: 196934767
• Report Number: 2916596-2020-03103
• 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: 08/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/21/2022
• Device Model Number: 106524US
• Device Catalogue Number: 106524US
• Device Lot Number: 7275033
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 69 YR
• Patient Weight: 95