THORATEC® HEARTMATE 3® LVAS IMPLANT KIT
Report
- Report Number
- 2916596-2025-01219
- Event Type
- Malfunction
- Date Received
- March 2, 2025
- Date of Event
- June 1, 2023
- Report Date
- April 21, 2025
- Manufacturer
- THORATEC CORPORATION
- Product Code
- DSQ
- PMA / PMN Number
- P160054
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
B5: SPECIFIC PATIENT INFORMATION AND DEVICE SERIAL NUMBER ARE DOCUMENTED AS UNKNOWN. DEVICE WAS IMPLANTED AT TIME OF EVENT. DATE OF EVENT HAS BEEN ENTERED AS: 01JUN2023 AS PATIENTS WERE IMPLANTED FROM MAR2015 TO JUN2023. DEPARTMENT OF CARDIAC, THORACIC, VASCULAR SCIENCES AND PUBLIC HEALTH, UNIVERSITY OF PADOVA, PADUA, ITALY, DEPARTMENT OF CLINICAL ELECTROPHYSIOLOGY & CARDIAC PACING, CENTRO CARDIOLOGICO MONZINO, IRCCS, MILAN, ITALY, DEPARTMENT OF SYSTEMS MEDICINE, UNIVERSITY OF ROME TOR VERGATA, ROME, ITALY, CARDIOLOGY UNIT, LUIGI SACCO UNIVERSITY HOSPITAL, MILAN, ITALY, CARDIOLOGY UNIT, IRCCS, DEPARTMENT OF EXPERIMENTAL, DIAGNOSTIC AND SPECIALTY MEDICINE, SANT'ORSOLA HOSPITAL, UNIVERSITY OF BOLOGNA, BOLOGNA, ITALY, ARRHYTHMOLOGY AND ELECTROPHYSIOLOGY UNIT, SAN RAFFAELE HOSPITAL, IRCCS, MILAN, ITALY,CARDIOLOGY UNIT, UNIVERSITY MEDICAL CENTRE MANNHEIM, MANNHEIM, GERMANY, DEPARTMENT OF CARDIOLOGY AND ANGIOLOGY, FACULTY OF MEDICINE, HEART, CENTER FREIBURG UNIVERSITY, UNIVERSITY OF FREIBURG, GERMANY,CARDIOLOGY UNIT, FONDAZIONE IRCCS SAN GERARDO DEI TINTORI, MONZA, ITALY, DEPARTMENT OF RHYTHMOLOGY, UNIVERSITY HEART CENTER LUBECK, LUBECK, GERMANY, DEPARTMENT OF BIOMEDICAL SURGICAL AND DENTAL SCIENCES, UNIVERSITY OF MILAN, MILAN, ITALY, MONTEFIORE-EINSTEIN CENTER FOR HEART AND VASCULAR CARE, MONTEFIORE MEDICAL CENTER, ALBERT EINSTEIN COLLEGE OF MEDICINE AT MONTEFIORE HEALTH SYSTEM, BRONX, NY, USA, DIVISION OF CARDIOLOGY, DEPARTMENT OF MEDICINE, THE JOHNS HOPKINS UNIVERSITY SCHOOL OF MEDICINE, BALTIMORE, USA. MIGLIORE, F., SCHIAVONE, M., PITTORRU, R., FORLEO, G. B., DE LAZZARI, M., MITACCHIONE, G., BIFFI, M., GULLETTA, S., KUSCHYK, J., DALL¿AGLIO, P. B. ROVARIS, G., TILZ, R., MASTRO, F. R., ILICETO, S., TONDO, C., DI BIASE, L., GASPERETTI, A., TARZIA, V., & GEROSA, G. (2024). LEFT VENTRICULAR ASSIST DEVICE IN THE PRESENCE OF SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR: DATA FROM A MULTICENTER EXPERIENCE. INTERNATIONAL JOURNAL OF CARDIOLOGY, 400, 131807. HTTPS://DOI.ORG/10.1016/J.IJCARD.2024.131807. THE REPORTABLE AWARE DATE IS THE DATE THE SJM NOTIFIER COMPLETED READING THE ARTICLE AND ENTERED IN THE COMPLAINT DATABASE (PER SECTION 6.3.4 OF 90979616). NO FURTHER INFORMATION PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER INVESTIGATION IS COMPLETE.
SECTION B3: DATE OF EVENT CORRECTED. DATE OF EVENT HAS BEEN ENTERED AS 01JUN2023 AS PATIENTS WERE IMPLANTED FROM (B)(6) 2015 TO (B)(6) 2023. SECTION E: REPORTER INFORMATION CORRECTED. SECTION G2: REPORT SOURCE CORRECTED. MANUFACTURER'S INVESTIGATION CONCLUSION: A SPECIFIC CAUSE FOR THE REPORTED INTERFERENCE COULD NOT BE CONCLUSIVELY DETERMINED, AND A DIRECT CORRELATION WITH HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS) COULD NOT BE CONCLUSIVELY ESTABLISHED THROUGH THIS EVALUATION. NO DEVICES WERE RETURNED FOR THIS EVALUATION. THE DEVICE SERIAL NUMBERS WERE NOT REPORTED AND WERE UNABLE TO BE DETERMINED DURING THIS EVALUATION. HEARTMATE 3 (HM3) LEFT VENTRICULAR ASSIST SYSTEM (LVAS) INSTRUCTIONS FOR USE (IFU) CONTAINS WARNINGS IN THE INTRODUCTION, SURGICAL PROCEDURES, AND PATIENT CARE AND MANAGEMENT SECTIONS THAT THAT THE PUMP MAY CAUSE INTERFERENCE WITH ICDS (IMPLANTABLE CARDIOVERTER DEFIBRILLATORS). IF ELECTROMAGNETIC INTERFERENCE OCCURS IT MAY LEAD TO INAPPROPRIATE ICD THERAPY. THE OCCURRENCE OF ELECTROMAGNETIC INTERFERENCE WITH ICD SENSING MAY REQUIRE ADJUSTMENT OF DEVICE SENSITIVITY AND/OR REPOSITIONING THE LEAD. PRIOR TO IMPLANTING AN ICD OR IPM (IMPLANTABLE PACEMAKER) IN AN HM3 PATIENT, THE DEVICE TO BE IMPLANTED SHOULD BE PLACED IN CLOSE PROXIMITY TO THE HM3 PUMP AND THE TELEMETRY VERIFIED. IF THE PATIENT RECEIVED A HEARTMATE 3 AND HAS A PREVIOUSLY IMPLANTED DEVICE THAT IS FOUND TO BE SUSCEPTIBLE TO PROGRAMMING INTERFERENCE, THE MANUFACTURER RECOMMENDS REPLACING THE ICD DEVICE WITH ONE THAT IS NOT PRONE TO PROGRAMMING INTERFERENCE. THE SAFETY TESTING AND CLASSIFICATION SECTION OF THE IFU STATES THAT IF THE HM3 LVAS DOES CAUSE INTERFERENCE TO ANOTHER DEVICE, THE USER IS ENCOURAGED TO TRY TO CORRECT THE INTERFERENCE BY REORIENTING OR RELOCATING THE EQUIPMENT, INCREASE THE SEPARATION BETWEEN THE EQUIPMENT, CONNECT THE EQUIPMENT TO AN OUTLET ON A CIRCUIT DIFFERENT FROM THAT TO WHICH OTHER DEVICES ARE CONNECTED, OR CONTACT THE MANUFACTURER FOR ASSISTANCE. THE CURRENT REVISIONS OF THE INSTRUCTIONS FOR USE (IFU) AND PATIENT HANDBOOK CAN ALSO BE FOUND ON THE ELECTRONIC IFU (EIFU) PAGE OF THE ABBOTT WEBSITE. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.
IT WAS REPORTED THROUGH THE ARTICLE TITLED "LEFT VENTRICULAR ASSIST DEVICE IN THE PRESENCE OF SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR: DATA FROM A MULTICENTER EXPERIENCE¿ THAT THE HEARTMATE 3 MAY BE ASSOCIATED WITH CARDIAC ARRHYTHMIAS, ELECTROMAGNETIC INTERFERENCE (EMI), HEART TRANSPLANT (HT), AND DEATH. THIS WAS A MULTICENTER RETROSPECTIVE COHORT STUDY AMONG PATIENTS WITH A PREEXISTING SUBCUTANEOUS IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR (S-ICD) WHO UNDERWENT LEFT VENTRICULAR ASSIST DEVICE (LVAD) IMPLANTATION FOR ADVANCED HF DESPITE OPTIMAL MEDICAL THERAPY FROM MARCH 2015 AND JUNE 2023. THE STUDY POPULATION INCLUDED 30 PATIENTS (N = 25 MALES, 83.3%; MEDIAN AGE: 45 [38¿52] YEARS). THE MEDIAN TIME FROM S-ICD IMPLANTATION TO LVAD DEVICE IMPLANTATION WAS 12 [6¿25] MONTHS. BASELINE CLINICAL CHARACTERISTICS OF THE STUDY POPULATION INCLUDED THAT SEVEN (23%) PATIENTS RECEIVED AN S-ICD FOR SECONDARY PREVENTION. MOST PATIENTS HAD NON-ISCHEMIC CARDIOMYOPATHY (N = 23; 76.7%) WITH A MEDIAN LEFT VENTRICULAR (LV) EJECTION FRACTION OF 15 [15¿22]. INDICATIONS FOR LVAD IMPLANTATION WERE BRIDGE TO HT (N = 15; 50%), BRIDGE TO HT CANDIDACY (N = 13; 43%) AND DESTINATION THERAPY (N = 2; 7%). IMPLANTED LVAD MODELS WERE HEARTMATE III (N =19; 63%), HEARTWARE (N =5; 17%), JARVIK 2000 (N =5; 17%) AND LEVITRONIX, PARACORPOREAL LVAD (N =1; 3%). FROM THE BASELINE PATIENT CHARACTERISTICS PROVIDED. 7 OF THE 30 PATIENTS HAD KIDNEY DISEASE, AND 2 HAD ATRIAL FIBRILLATION (AF). EMI OVERSENSING IN AT LEAST 1 SENSING VECTOR OCCURRED IN 21 (70%) PATIENTS: 14 OF 19 (73%) WITH THE HEARTMATE III, 4 OF 5 (80%) WITH THE JARVIK 2000, 3 OF 5 (60%) WITH THE HEARTWARE (SEE FIG. 1). SIX PATIENTS (20%) EXPERIENCED A TOTAL OF 95 INAPPROPRIATE SHOCKS (IS) DUE TO EMI. SIX PATIENTS (20%) EXPERIENCED A TOTAL OF 14 APPROPRIATE SHOCKS FOR VENTRICULAR TACHYCARDIA (VT)/ VENTRICULAR FIBRILLATION (VF). NO COMPLICATIONS OCCURRED. NO S-ICD EXTRACTION BECAUSE OF NEED FOR ATP, INEFFECTIVE THERAPY, OR INFECTION WAS REPORTED. DURING FOLLOW-UP, 5 PATIENTS (16%) UNDERWENT HT AND 7 PATIENTS (23%) DIED BECAUSE OF CARDIAC DEATH DUE TO WORSENING HF. HEARTMATE 3 AND HEARTWARE HVAD OPERATE AT A LOWER ROTATIONAL SPEED, GENERATING LOW FREQUENCY EMI (30¿150 HZ) THAT IS LESS LIKELY TO BE REMOVED BY DEVICE FILTERS RESULTING IN EMI OVERSENSING AND INAPPROPRIATE THERAPY [11]. IN CONCLUSION, CONCOMITANT USE OF LVADS AND S-ICDS WAS FEASIBLE IN MOST PATIENTS. HOWEVER, THE POTENTIAL RISK OF EMI OVERSENSING, IS, AND UNDER SENSING IN THE POST-OPERATIVE PERIOD FOLLOWING LVAD IMPLANTATION SHOULD BE CONSIDERED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1146759 | THORATEC® HEARTMATE 3® LVAS IMPLANT KIT | VENTRICULAR (ASSIST) BYPASS | DSQ | THORATEC CORPORATION | 106524INT |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |