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

Model Number 106524US

Device Problem Mechanical Problem (1384)

Patient Problems Right Ventricular Dysfunction (2054); Thrombus (2101)

Event Date 02/21/2020

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's pump was exchanged due to pump thrombosis.The patient had ventricular tachycardia arrest and the pump stopped and restarted but flows did not return and the speed decreased to 3500 rpm.The patient was reintubated and resuscitation was initialed including cardioversion and cpr.Pump auscultation was normal at the time.The patient was emergently taken to the operating room for bypass and transesophageal echocardiography (tee) revealed dilated left ventricle and absent flow from the lvad.The pump was exchanged due to excess clot in the inflow which was likely due to the stasis in during arrest.The patient was placed on a tandem rvad with oxygenator, due to right ventricular dysfunction requiring increasing inotrope support.The patient's chest was left open and the explanted pump was returned.

Manufacturer Narrative

Section h3: additional information manufacturer's investigation conclusion: low flow events were confirmed based on the retrieved log file data.A direct correlation between (b)(6) and the reported ventricular tachycardia cannot be conclusively determined through this investigation.The retrieved left ventricular assist device (lvad) event log file contained relevant data spanning from (b)(6) 2020 at 19:28:32 to (b)(6) 2020 at 18:00:49, per the timestamp.From (b)(6) 2020 at 19:28:32 through (b)(6) 2020 at 14:46:23 average flow ranged from 1.7 to 4.4 liters per minute (lpm).Beginning on (b)(6) 2020 at 17:02:54, a decrease in flow was observed for the remainder of the log file, with average flow ranging from 0.0-1.5lpm.A specific cause for these low calculated flow values could not be conclusively determined through this evaluation.The device was returned assembled with the pump cable severed approximately 5¿ from the pump header.A severed portion of pump cable measuring approximately 13¿ was also returned.Approximately 3¿ of the sealed outflow graft was returned detached from the device.The apical cuff and modular cable were not returned.Examination of the pump's blood-contacting surfaces revealed depositions of clotted blood admixed with post-explant blood were observed in the inflow cannula and in the rotor vanes.These depositions appeared to have developed as a result of poor surface washing due to a low flow event or interruption in flow, consistent with the data captured in the lvad event log file.No adhered/developed depositions or thrombus formations were observed during the evaluation of the returned device.Visual inspection of the pump rotor and rotor well did not reveal any obvious surface scratches or defects.The device was cleaned, rebuilt, and tested under loaded conditions on a mock circulatory loop.The device functioned as intended and in accordance with manufacturing specifications.The heartmate 3 left ventricular assist system (lvas) instructions for use (ifu) 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.The ifu explains that the low flow hazard alarm will be triggered when pump flow is less than 2.5lpm and notes that changes in patient conditions can result in low flow.The ifu, as well as the patient handbook, describe all system alarms and the recommended actions associated with them.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 95488
• MDR Report Key: 9831819
• MDR Text Key: 184317005
• Report Number: 2916596-2020-01113
• 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: 05/29/2020

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/02/2022
• Device Model Number: 106524US
• Device Catalogue Number: 106524US
• Device Lot Number: 7370324
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/24/2020
• Initial Date FDA Received: 03/13/2020
• Supplement Dates Manufacturer Received: 05/28/2020
• Supplement Dates FDA Received: 05/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 67 YR
• Patient Weight: 114