MAUDE Adverse Event Report: Thoratec Corporation Thoratec® HeartMate 3® LVAS Implant Kit; Ventricular (Assist) Bypass

Model Number	106524US
Medical Device Problem Codes	Infusion or Flow Problem (2964); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pulmonary Embolism (1498); Low Blood Pressure/ Hypotension (1914); Pulmonary Edema (2020); Ventricular Fibrillation (2130)
Date of Event	08/29/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient had zero flow on the night of (b)(6) 2026 and the next morning.Log files were sent for review.The event log captured a drop in flow on(b)(6) 2026 around 23:00 with estimated flows hovering around the 2.4 to 2.5 lpm range.These lower flows continued throughout most of the log with zero flow noted on (b)(6) 2026 at 23:40.Flow recovered back into the 2 lpm range a few minutes later with continued low flow events.It was also noted that the fixed speed was changed multiple times during these low flow periods sometimes causing low speed advisory events.By the end of the data capture, the estimated flows were back into the 4 lpm range.The patient had an acute hypotension and loss of left ventricular assist device (lvad) flows (down to 1.7l).A transesophageal echocardiogram (tee) showed left ventricle (lv) completely decompressed/empty, right ventricle (rv) blown out/not moving flow.Carbon dioxide (co2) was up to 80s.Emergent right ventricular assist device (rvad) circuit exchanged with oxygenator.Ventricular fibrillation was noted and 1 shock was performed to normal sinus rhythm (nsr).Lvad flows restored, with rv/lv normal filling/size.Total resuscitation: 4 red blood cell count (rbcs), epinephrine x5 push dose sticks, 250 5% albumin x6, 50 lactated ringer's (lr), started iflolan.Stat bronchoscopy revealed large clot obstructing carina and red frothy pulmonary edema.Clot was unable to be extracted.
Additional Manufacturer Narrative
No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is complete.

• 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: fredric gold ; 6035 stoneridge drive; pleasanton, CA 94588 ; +1(781)852-8207
• MDR Report Key: 50885600
• Report Number: 2916596-2026-2919666
• Device Sequence Number: 9799669
• Product Code: DSQ
• UDI-Device Identifier: 05415067039323
• UDI-Public: (01)05415067039323(17)280116
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: P160054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/24/2026

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
• Operator of Device: Lay User/Patient
• Device Model Number: 106524US
• Device Catalogue Number: 106524US
• Device Lot Number: 11464190
• 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: 09/01/2026
• Initial Report FDA Received Date: 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/20/2026
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 44 YR
• Patient Sex: Male
• Patient Weight: 140 LB