HEARTMATE 3 LVAS
Received Jun 23, 2026 · Event occurred Jun 12, 2026
Report MW5189807 · MDR key 25598307
Device
Generic name
Ventricular (assist) Bypass
Manufacturer
Thoratec Corp/ Abbott LaboratoriesPatient
76 YR · Male
- Atrial Fibrillation
- Tachycardia
- Obstruction/Occlusion
- Cardiovascular Dysfunction/Insufficiency
- Heart Failure/Congestive Heart Failure
- Mitral Valve Insufficiency/ Regurgitation
Narrative
Description of Event or Problem
A 76-YEAR-OLD WITH ISCHEMIC DILATED CARDIOMYOPATHY COMPLICATED BY COMBINED SEVERE LEFT VENTRICULAR SYSTOLIC AND DIASTOLIC HEART FAILURE, MODERATE RIGHT VENTRICULAR DYSFUNCTION, MODERATE-SEVERE MITRAL REGURGITATION, MODERATE TRICUSPID REGURGITATION, NON-SUSTAINED VENTRICULAR TACHYCARDIA AND PERSISTENT ATRIAL FIBRILLATION STATUS POST HEARTMATE 3 LEFT VENTRICULAR ASSIST DEVICE (B)(6) 2020. SURVEILLANCE COMPUTED TOMOGRAPHY SCANNING SHOWED DEVELOPMENT OF SIGNIFICANT EXTRINSIC OUTFLOW GRAFT OBSTRUCTION. DIFFICULT SUBCOSTAL DISSECTION AS DRIVELINE OVERLYING OUTFLOW GRAFT AND EVERYTHING WAS QUITE DEEP. PROXIMAL APPROX. 2 INCHES OF BEND RELIEF OPENED AND MODERATE AMOUNT OF PROTEINACEOUS MATERIAL EVACUATED. NO FURTHER OBSTRUCTIVE MATERIAL VISUALIZED DISTALLY. PROCEDURE UNCOMPLICATED. NO OBVIOUS EVIDENCE OF ACTIVE INFECTION/ABSCESS. BLAKE DARAIN PLACED IN SUBCOSTAL POCKET. FOREIGN BODY/SPONGE SENT TO PATHOLOGY. PATIENT EXTUBATED IN POST ANESTHESIA CARE UNIT. NO SIGNIFICANT BLEEDING. NO VENTRICULAR ASSIST DEVICE ALARMS POSTOP.