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

Model Number 106524US

Device Problem Malposition of Device (2616)

Patient Problems Fatigue (1849); Dizziness (2194)

Event Date 08/17/2021

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 experienced ventricular assist device displacement.The cause of the displacement was unknown.The patient experienced dizziness and as of (b)(6) 2021 was medically stable.The patient is ongoing and may receive a heart transplant.

Event Description

It was noted on (b)(6) 2021 that the patient had ongoing dizziness but was medically stable.A possible heart transplant was considered as plan of care.The patient had struggled with low flow alarms post vad implant and has had 2.0 low flow software installed.Due to the patient's ongoing low flow alarms with dizziness and fatigue, a computed tomography angiography (cta) was done on (b)(6) 2021.The cta showed interval rotation of the outflow cannula tip at the left ventricular (lv) apex towards the myocardium of the distal anterior wall which partially covered the cannula up to the 60% at systole and partially filled the outflow cannula at the diastole end and to a greater degree during systole (as best displayed on sine images through the cannula tip).On (b)(6) 2021, the patient was asked to present to the hospital for admission for surgical intervention and was admitted.The patient is now listed status 2 for heart transplant due to device malfunction and waiting.A heart transplant was completed on (b)(6) 2021.

Manufacturer Narrative

No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed. .

Manufacturer Narrative

Manufacturer's investigation conclusion: a specific cause for the reported pump malposition could not conclusively determined through the evaluation of (b)(6).The evaluation of the submitted log files confirmed the reported low flow alarms.Discoloration of the pump cable inline connector was also observed.The submitted controller event log file captured 42 low flow hazard alarms along with intermittent low flow events throughout the course of the log file.No other atypical events or alarms were captured.The system appeared to operate as intended at the set speed for the duration of the file.(b)(6) was returned assembled with the pump cable severed approximately 9.5¿ from the pump header.Approximately 12¿¿ of the middle segment and 5¿¿ of the distal end of the pump cable was returned attached to the modular cable.The outflow graft and outflow graft bend relief was returned attached to the pump cover outlet port.The apical cuff was returned with the cuff lock properly secured.Examination of the pump cable inline connector bend relief revealed tan discoloration.The pump header and pump end bend relief appeared unremarkable.Visual inspection of the inflow and outflow cannulas did not reveal any laminated or denatured depositions or thrombus formations.Upon disassembly of the pump body, examination of the blood-contacting surfaces revealed no evidence of developed or adhered depositions or thrombus formations.Visual inspection of the pump rotor and rotor well did not reveal any surface scratches of defects.The lvad event and periodic log files were retrieved from the returned device.Temperature, rotor displacement, and rotor noise remained stable throughout the log files.The log files appeared to capture the device functioning as intended, despite several low flow events.(b)(6) was cleaned, reassembled, and functionally tested on mock circulatory loop.The device functioned as intended and in accordance with manufacturing specifications.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 (b)(6) 2021.The heartmate 3 left ventricular assist system (lvas) instruction for use (ifu) and the heartmate 3 lvas patient handbook are currently available.Section 1 of the ifu addresses all pump parameters, including pump flow.Section 4, ¿system monitor¿, describes the pump flow display and the hazard alarms.The ifu states that per design, when the estimated flow value is calculated at less than 2.0 lpm, a low flow status is posted to the log file.If the flow remains below 2.0 lpm for 10 seconds, a low flow hazard alarm is triggered.This section also explains that changes in patient condition can result in low flow.The ifu section 5 entitled ¿surgical procedures¿ explains how to insert the pump in the ventricle and instructs the user to take care to avoid orienting the inlet towards the interventricular septum.Pump function will be compromised in the presence of inlet obstruction.This section also outlines the steps to reorient the pump.Section 7 of the ifu, "alarms and troubleshooting", and section 5 of the patient handbook, "alarms and troubleshooting", address all system alarm conditions as well as the appropriate actions associated with each condition.The ifu and patient contain information on caring for the driveline.Section 8 ¿equipment storage and care¿ in the ifu states that a damp cloth can be used to clean exterior surfaces of the external parts of the equipment.Water, with or without a mild dish soap, may be used as a surface cleaner.Section 8 also warns that patients should never submerge the driveline in water or liquid.Section 6 ¿caring for the equipment¿ in the patient handbook also outlines proper driveline maintenance for the patient.The user should check the driveline daily for signs of damage (cuts, holes, tears) and call their hospital contact right away if the driveline is damaged (or might be damaged).Section 7 of the ifu, "alarms and troubleshooting", and section 5 of the patient handbook, "alarms and troubleshooting", address all system alarm conditions as well as the appropriate actions associated with each condition.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: bob fryc ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528204
• MDR Report Key: 12456596
• MDR Text Key: 270918521
• Report Number: 2916596-2021-04897
• 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,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 11/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/13/2022
• Device Model Number: 106524US
• Device Catalogue Number: 106524US
• Device Lot Number: 7812970
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/08/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/23/2021
• 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): Hospitalization; Required Intervention; Other
• Patient Age: 42 YR
• Patient Sex: Male
• Patient Weight: 79 KG