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

Model Number 106524US

Device Problems Gas/Air Leak (2946); Infusion or Flow Problem (2964)

Patient Problems No Code Available (3191); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 09/30/2020

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 had a hm3 thoracotomy.The patient had persistent, significant air in the left ventricle despite 30-40 minutes de-airing.The patient went back on full bypass and unlocked pump and removed from apical cuff then reinserted and locked back into place.There was no bleeding between the heart/cuff and cuff/pump.Surgeons twisted pump, then increased speed from 4800 to 5000 rpm, with a noticeable increase in left ventricle air on echo.The flow was 2.2 lpm, then flow dropped to 0 lpm, presumably from air inside the pump.Chest flooded with saline and lv air decreased.The surgeons used surgicel and bioglue to seal the cuff/pump interface, which resolved the air.De-airing was quickly achieved and remainder of the case proceeded without any further issues related to vad.

Manufacturer Narrative

Manufacturer's investigation conclusion: a specific cause for the reported event could not conclusively be determined through this evaluation.It was reported that the patient¿s heartmate 3 implantation was prolonged due to de-airing difficulties, despite no changes to the de-airing technique.Significant air was observed in the left ventricle from an echocardiogram (echo) with corresponding low flow alarms.No bleeding occurred.The surgeon unlocked the pump, removed it from the apical cuff, and locked the pump back into place.The pump was then slightly twisted back and forth to try to better engage the seal, flooding the patient¿s chest with saline, and then further securing the pump/cuff with surgical glue.De-airing was quickly achieved and the remainder of the implant proceeded without any further issues related to the ventricular assist device (vad).The patient remained ongoing on heartmate 3 left ventricular assist system (lvas), serial number (b)(6) until (b)(6)2020, when the patient expired.The pump was not explanted (related manufacturer report number: 2916596-2020-05242).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 20aug2020.The heartmate 3 left ventricular assist system (lvas) instructions for use (ifu), is currently available.Section 1 provides an explanation of all pump parameters, including flow.Section 4 provides information for the system monitor describing the pump flow display and the hazard alarms.This ifu states that the low flow hazard alarm will be triggered when pump flow is less than 2.5 liters per minute (lpm).The ifu explains that changes in patient conditions can result in low flow.Section 5 ¿surgical procedures¿ (under ¿preparing the ventricular apex site¿) contains information regarding the preparation of the ventricular apex site, including how to affix the apical cuff to the left ventricle.This section cautions that after the apical cuff has been sewn to the heart, the metal ring on the apical cuff should extend above the felt surface to allow proper engagement and locking with the slide lock of the heartmate 3 lvad.Ensure that apposition between the myocardial tissue and the cuff felt is continuous and sufficiently forceful to prevent bleeding.Section 5 ¿surgical procedures¿ (under ¿de-airing the pump¿) provides information regarding how to properly de-air the pump during implant and includes steps of the process.The ifu warns that prolonged de-airation may be due to inadequate blood supply to the left ventricular assist device or a leak in the sealed outflow graft or sealed inflow cannula.This ifu also warns that a complete backup system must be available on-site and in close proximity for use in an emergency.Section 7 ¿alarms and troubleshooting¿ describes all alarm conditions, including the low flow hazard, as well as the appropriate actions associated with them.The heartmate 3 lvas patient handbook, is also currently available.Section 5 "alarms and troubleshooting" outlines all system controller alarms as well as how to respond to each alarm condition.No further information was provided.The manufacturer is closing the file on this event.

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 (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: lindsey sallese ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528207
• MDR Report Key: 10692109
• MDR Text Key: 211732821
• Report Number: 2916596-2020-04989
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Remedial Action: Notification
• Type of Report: Initial,Followup,Followup
• Report Date: 04/17/2024

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: Health Professional
• Device Expiration Date: 09/06/2022
• Device Model Number: 106524US
• Device Catalogue Number: 106524US
• Device Lot Number: 7603589
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/30/2020
• Initial Date FDA Received: 10/16/2020
• Supplement Dates Manufacturer Received: 02/26/2021; 02/26/2021
• Supplement Dates FDA Received: 03/05/2021; 04/17/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/29/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: FA-Q124-HF-2
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 57 YR
• Patient Sex: Female
• Patient Weight: 99 KG