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

Model Number	106524US
Medical Device Problem Codes	Device Difficult to Setup or Prepare (1487); No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	Stroke/CVA (1770); Hemorrhage/Blood Loss/Bleeding (1888); Shock (2072); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/29/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section d4: device serial number and lot number were not provided, and expiration date and manufacture date (h4) cannot be determined.The primary udi number in d4 is reflective of all available information.No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is complete.
Event or Problem Description
It was reported that the patient had a pump exchange due to infection.It was noted that the locking mechanism was unable to be unlocked using an unlocking tool.The apical cuff was removed.
Additional Manufacturer Narrative
This report was determined to be supplemental information to mfr # 2916596-2024-05923.The infection and the locking mechanism issue will be documented on (b)(6), there is no allegation against a second device.Investigation findings will be submitted under mfr # 2916596-2024-05923.
Additional Manufacturer Narrative
No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is complete.
Event or Problem Description
It was additionally reported through voluntary medwatch report mw5161965 that the patient had a history of dilated nonischemic cardiomyopathy complicated by severe left ventricular systolic dysfunction, mild right ventricular systolic dysfunction, severe mitral regurgitation, and paroxysmal atrial fibrillation in secondary to alcohol, cocaine, and methamphetamines use.The status post left ventricular assist device (lvad) and tricuspid valve repair with a 28 mm mc3 annuloplasty ring 2021.Since 2023 they have had hospitalizations for methicillin-susceptible staphylococcus aureus (mssa) bacteremia.The patient had subarachnoid hemorrhage at the time thought to be secondary to mycotic aneurysm.In 2023 they were hospitalized again for persistent mssa bacteremia, had their implantable cardioverter-defibrillator (icd) explanted and completed 6 weeks of intravenous (iv) antibiotics.After they were transitioned to cefadroxil indefinitely for suppression of infection.They then presented with a fever of 103.2 with symptoms of nausea, vomiting, and chills.The patient had stopped taking cefadroxil in 2024 due to no refills as they hadn't been seen in the clinic.They were treated with iv antibiotics until blood cultures cleared.The patient was taken to the operating room for pump exchange in 2024.Intraoperatively, pus encountered in the proximal part of the outflow graft in the region of the bend relief.The case was notable for bleeding, shock, and prolonged cardiopulmonary bypass (cbp) time (about 7 hours).Subsequently the patient was noted to have motor deficits and stat computed tomography (ct).The imaging showed basilar artery occlusion resulting in pontine stroke with significant ongoing motor/neurological deficits.The patient had a trach placed and percutaneous endoscopic placed (b)(6) 2024.The patient was discharged to a rehab hospital in 2024.
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: a direct correlation between heartmate 3 left ventricular assist system (lvas), serial number (b)(6), and the reported event could not conclusively be established through this evaluation.The patient remains ongoing on heartmate 3 lvas, serial number (b)(6), and no further related events have been reported at this time.The relevant sections of the device history records for (b)(6) were reviewed and showed no deviations from manufacturing or quality assurance specifications.The heartmate 3 left ventricle assist system (lvas) instruction for use (ifu) is currently available.Section 1 of the ifu "introduction" lists the adverse events that may be associated with the use of the heartmate 3 left ventricular assist system, including stroke and bleeding.Section 6 ¿patient care and management¿ (under "anticoagulation") provides information regarding anticoagulation, including recommended international normalized ratio (inr) values, and the suggested anticoagulation modifications in the event there is a risk of bleeding.No further information was provided.The manufacturer is closing the file on this event.
Additional Manufacturer Narrative
No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: THORATEC® HEARTMATE 3® LVAS IMPLANT KIT
• Common Device Name: 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: 20226710
• Report Number: 2916596-2024-05924
• Device Sequence Number: 3504963
• Product Code: DSQ
• UDI-Device Identifier: 00813024013266
• UDI-Public: (01)00813024013266(17)260430
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P160054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Notification
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 03/06/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2026
• Device Model Number: 106524US
• Device Catalogue Number: 106524US
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/29/2024
• Supplement Date Received by Manufacturer: 11/05/2024; 12/18/2024; 01/21/2025; 02/14/2025
• Initial Report FDA Received Date: 09/16/2024
• Supplement Report FDA Received Date: 11/20/2024; 01/09/2025; 01/31/2025; 03/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/06/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: FA-Q124-HF-1
• Patient Sequence Number: 1
• Patient Age: 41 YR
• Patient Sex: Female
• Patient Weight: 67 KG