HEARTMATE 2 LVAS
Received Mar 9, 2026 · Event occurred Jan 28, 2026
Report MW5184939 · MDR key 24548796
Device
Generic name
Ventricular (assist) Bypass
Manufacturer
Abbott Labratories / Thoratec Corp.Patient
41 YR · Male
- Insufficient Information
Narrative
Description of Event or Problem
A 41 Y.O. MALE WITH NONISCHEMIC, DILATED CARDIOMYOPATHY S/P LVAD PLACEMENT WITH HEARTMATE II ON (B)(6) 2014 WITH MVRR #32 AND TVRR #36 AS BRIDGE TO RECOVERY WITH NICM WITH SEVERE MR AND TR. S/P PRIMARY PREVENTION ICD. DECISION MADE TO CONTINUE TO TAKE ADVANTAGE OF HIS EXCELLENT CLINICAL STATUS ON VAD SUPPORT IN ORDER TO DEFER TRANSPLANTATION AS LONG AS SAFELY POSSIBLE GIVEN HIS RELATIVELY YOUNG AGE AND HIS DESIRE TO DELAY TRANSPLANT. RECENTLY ADMITTED (B)(6) 2025 WITH LOW SPEED, LOW FLOW AND LVAD STOP ALARMS. AFTER EXTENSIVE EVALUATION DID NOT DEMONSTRATE DRIVELINE FAULT/FRACTURE, SHORT TO SHIELD OR OTHER ELECTRICAL ABNORMALITY, CONTROLLER WAS CHANGED WITH RESOLUTION OF ALARMS. HE WAS DISCHARGED HOME. NOW READMITTED WITH RECURRENT PUMP STOPPAGES X 2 ON BATTERY POWER (1ST X 5 SECONDS; 2ND X 30 SECONDS). HE REPORTS THAT AS WITH HIS PRIOR PUMP STOPPAGES THESE OCCURRED WHILE ON COMMODE STRAINING TO HAVE A BOWEL MOVEMENT. AS WITH HIS PRIOR EVENTS THESE OCCURRED ON BATTERY POWER. DURING THE SECOND LONGER PUMP STOPPAGE THERE WAS NO SYNCOPE/PRESYNCOPE. HE DENIES RECENT DL TRAUMA. HE DENIES WORSENING HF SYMPTOMS OR PUMP PARAMETER DERANGEMENTS BEFORE OR AFTER THE EVENTS. UNDERWENT REDO STERNOTOMY WITH HEARTMATE 2 TO HEARTMATE 3 PUMP EXCHANGE ON (B)(6) 2026 WITHOUT COMPLICATION. PRODUCT ANALYSIS SHOWS BREAKDOWN OF 3 OF THE 6 WIRES IN THE HEARTMATE 2 DRIVELINE.