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

Model Number 106524US

Device Problems Mechanical Problem (1384); Infusion or Flow Problem (2964)

Patient Problems Aneurysm (1708); Dyspnea (1816); Thrombosis/Thrombus (4440); Heart Failure/Congestive Heart Failure (4446); Aortic Valve Insufficiency/ Regurgitation (4450); Mitral Valve Insufficiency/ Regurgitation (4451)

Event Date 12/14/2023

Event Type  Death  

Event Description

It was reported that the patient presented to the clinic with low flow alarms, dyspnea, and chest pressure.The patient was stabilized in the emergency department (ed) on dobutamine and levosimendan (levophed).A computed tomography (ct) scan of the chest was performed.Chest ct showed the inflow cannula was occluded with thrombus, the pumping chamber was occluded with thrombus and the outflow graft to the aorta was nearly occluded with thrombus.There was also question of layering thrombus within the left ventricle.The international normalized ratio (inr) was therapeutic.The patient was given tissue plasminogen activator (tpa) in a single large dosage and as a continued infusion.The patient was admitted to the critical care unit (ccu) and was intubated.Log files were submitted for review and captured the onset of the persistent low flow estimates as well as sustained low flow hazard events on 08mar2024.Mechanical circulatory support (mcs) equipment was operating as expected.It was additionally reported that the patient had a suspected extrinsic outflow graft obstruction.There were no changes to patient condition or anticoagulation status that may have contributed.A transthoracic echocardiogram (tte) and a transesophageal echocardiogram (tee) were performed.The tte showed that the entire apex of the left ventricle (lv) was aneurysmal, and the lv ejection fraction was severely decreased (25%).The right ventricle (rv) was mildly dilated and hypokinetic.The tte additionally showed mild to moderate aortic regurgitation and mild pulmonary hypertension.The tee again captured the decrease in lv ejection fraction, the dilation of the rv, and the mild to moderate aortic regurgitation.The tee also captured mild mitral regurgitation.The inflow cannula was seen in the lv apex with color flow into the ventricular assist device (vad).It was noted that there was an implantable cardioverter defibrillator (icd) and a swanz-ganz-type catheter in the right heart, the aortic valve opens with every systole and no pericardial effusion was seen.Amplantzer vascular plugs were used to occlude the outflow graft and the vad was turned off.An intra-aortic balloon pump (iabp) was inserted, and the patient was transitioned to hospice care.The patient passed away in hospice on (b)(6) 2024.

Manufacturer Narrative

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

Manufacturer Narrative

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

Event Description

It was reported that the findings of the current transthoracic echocardiogram (tte) were similar to a tte performed on (b)(6) 2023 with no further information that the patient was treated at the time.

• Brand Name: HEARTMATE 3 LVAS IMPLANT KIT
• Type of Device: VENTRICULAR (ASSIST) 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: 18979982
• MDR Text Key: 338618868
• Report Number: 2916596-2024-01579
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/12/2024

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?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/13/2021
• Device Model Number: 106524US
• Device Lot Number: 6723481
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/08/2024
• Initial Date FDA Received: 03/26/2024
• Supplement Dates Manufacturer Received: 03/21/2024
• Supplement Dates FDA Received: 04/12/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/05/2018
• 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): Death
• Patient Age: 69 YR
• Patient Sex: Female
• Patient Weight: 57 KG