HEARTMATE 3 LEFT VENTRICULAR ASSIST DEVICE
Report
- Report Number
- 2916596-2021-07327
- Event Type
- Injury
- Date Received
- December 16, 2021
- Date of Event
- August 1, 2021
- Report Date
- January 11, 2022
- Manufacturer
- THORATEC CORPORATION
- Product Code
- DSQ
- PMA / PMN Number
- P160054
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- EZ
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
MANUFACTURER'S INVESTIGATION CONCLUSION: A DIRECT CORRELATION BETWEEN THE LVAD DEVICES AND THE REPORTED EVENTS COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION. THE RESEARCH ABSTRACT TITLED ¿INCREASED PULSATILITY INDEX IS ASSOCIATED WITH ADVERSE OUTCOMES IN LEFT VENTRICULAR ASSIST DEVICE (LVAD) RECIPIENTS¿, REPORTED THE FOLLOWING INFORMATION: A TOTAL OF 83 PATIENT, 34 IMPLANTED WITH HEARTMATE II (HMII) AND 49 IMPLANTED WITH HEARTMATE 3 (HM3) WERE ANALYZED FOR THIS STUDY. PULSATILE AND RESISTIVE INDEXES, ATHEROSCLEROTIC CHANGES IN THE CAROTID ARTERIES (MEASURED BY DUPLEX ULTRASOUND), AND ARTERIAL STIFFNESS (MEASURED BY ENDO=PAT 2000 AS THE AUGMENTATION INDEX (AI) STANDARDIZED FOR HEARTRATE (AI@75)) WERE EVALUATED 3 AND 6 MONTHS AFTER LVAD IMPLANTATION. SIXTEEN PATIENTS DIED DURING FOLLOW-UP. AFTER ADJUSTING FOR THE MAIN VARIABLES EXAMINED, THE PULSATILITY INDEX MEASURED AT 3 MONTHS WAS POSITIVELY ASSOCIATED WITH INCREASED HAZARD RATIONS (HR) FOR DEATH AND CEREBROVASCULAR EVENTS WITH AN HR OF APPROXIMATELY 9.8. THE HR INCREASED TO APPROXIMATELY 18.8 AFTER ADDING AI@75 TO THE MODEL. IN HM3 RECIPIENTS, HR WAS SIGNIFICANTLY LOWER THAN HMII RECIPIENTS, BUT THE SIGNIFICANCE DISAPPEARED AFTER ADDING AI@75 TO THE MODEL. THE STUDY CONCLUDED THAT THE RISK OF DEATH AND CEREBROVASCULAR EVENTS IN LVAD RECIPIENTS IS ASSOCIATED WITH INCREASED PULSATILITY INDEX IN CAROTID ARTERIES AND POTENTIATED BY INCREASED ARTERIAL STIFFNESS. THE SAME RISK IS ATTENUATED BY HM3 LVAD IMPLANTATION, BUT THIS EFFECT IS WEAKENED BY INCREASED ARTERIAL STIFFNESS. THE SAME RISK WAS ATTENUATED BY HM3 IMPLANTATION, BUT THIS EFFECT WAS WEAKENED BY INCREASED ARTERIAL STIFFNESS. THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED AS THE LVAD DEVICE SERIAL NUMBERS AS WELL AS OTHER SPECIFIC CASE/PATIENT INFORMATION, ARE NOT AVAILABLE. THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS) INSTRUCTIONS FOR USE (IFU) AND THE HEARTMATE 3 LVAS PATIENT HANDBOOK ARE CURRENTLY AVAILABLE. THIS IFU LISTS BLEEDING, STROKE, DEVICE THROMBUS, PERIPHERAL THROMBOEMBOLIC EVENTS, AND DEATH AS ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM. THIS DOCUMENT LISTS THROMBOEMBOLISM AS A POTENTIAL LATE POSTIMPLANT COMPLICATION AND PROVIDES INFORMATION REGARDING ANTICOAGULATION, INCLUDING THE RECOMMENDED INR VALUES, AS WELL AS SUGGESTED ANTICOAGULATION MODIFICATIONS IN THE EVENT THAT THERE IS A RISK OF BLEEDING. THE SECTION ENTITLED ¿INTRODUCTION¿ INSTRUCTS THE USER TO NOTIFY APPROPRIATE PERSONNEL IF THERE IS A CHANGE IN HOW THE PUMP WORKS, SOUNDS, OR FEELS. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.
SPECIFIC PATIENT INFORMATION AND DEVICE SERIAL NUMBER ARE DOCUMENTED AS UNKNOWN. DATE OF EVENT HAS BEEN ENTERED AS THE SAME AS PUBLISHED DATE (AUGUST 2021) SINCE DATE OF DATA COLLECTION WAS NOT PROVIDED. DEVICE WAS IMPLANTED AT TIME OF EVENT. ARTICLE INFORMATION: ZUZANA TUCANOVA, ET AL. ESC HEART FAILURE 2021; 8: 4288¿4295. DOI: 10.1002/EHF2.13537, DEPARTMENT OF CARDIOVASCULAR SURGERY, INSTITUTE FOR CLINICAL AND EXPERIMENTAL MEDICINE, (B)(6) 1958/9, PRAGUE, 140 21, CZECH REPUBLIC. NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.
IT WAS REPORTED THAT HEARTMATE 3 (HM3) MAY BE RELATED TO CEREBROVASCULAR EVENTS. A TOTAL OF 49 HM3 PATIENTS WERE EVALUATED. PULSATILE AND RESISTIVE INDEXES, ATHEROSCLEROTIC CHANGES IN CAROTID ARTERIES (MEASURED BY DUPLEX ULTRASOUND), AND ARTERIAL STIFFNESS [MEASURED BY ENDO-PAT 2000 AS THE AUGMENTATION INDEX STANDARDIZED FOR HEART RATE (AI@75)] WERE EVALUATED 3 AND 6 MONTHS AFTER LEFT VENTRICULAR ASSIST DEVICE (LVAD) IMPLANTATION. THE PULSATILITY INDEX MEASURED AT 3 MONTHS WAS POSITIVELY ASSOCIATED WITH INCREASED HAZARD RATIOS (HR) FOR CEREBROVASCULAR EVENTS [HR 9.8, 95% CONFIDENCE INTERVAL (CI) 1.62-59.42], WITH HR INCREASING AFTER ADDING AI@75 TO THE MODEL (HR 18.8, 95% CI 2.44-145.50). THE RISK OF CEREBROVASCULAR EVENTS IN LVAD RECIPIENTS IS ASSOCIATED WITH INCREASED PULSATILITY INDEX IN CAROTID ARTERIES AND POTENTIATED BY INCREASED ARTERIAL STIFFNESS. IN TOTAL, 17 HM3 PATIENTS WERE TRANSPLANTED. ADDITIONALLY, 2 HM3 PATIENTS SUFFERED FROM NON-FATAL ISCHEMIC STROKES, 12 HM3 PATIENTS EXPERIENCED ADVERSE EVENTS RELATED TO NON-SURGICAL BLEEDING (6 IN THE GASTROINTESTINAL TRACT, 1 IN THE URINARY TRACT, 2 IN THE RESPIRATORY TRACT, AND 3 IN OTHER LOCATIONS), AND IN ONE HM3 PATIENT, LVAD WAS REPLACED DUE TO THROMBOSIS. SIX PATIENTS WITH HM3 WERE TRANSIENTLY TREATED BY RVAD (MEAN DURATION OF 30.6 DAYS) SHORTLY AFTER IMPLANTATION OF LVAD, WHICH WAS SUCCESSFULLY REMOVED IN ALL PATIENTS.
IT WAS REPORTED THROUGH THE RESEARCH ARTICLE ¿INCREASED PULSATILITY INDEX IS ASSOCIATED WITH ADVERSE OUTCOMES IN LEFT VENTRICULAR ASSIST DEVICE RECIPIENTS¿ THAT HEARTMATE 3 (HM3) MAY BE RELATED TO CEREBROVASCULAR EVENTS. A TOTAL OF 49 HM3 PATIENTS WERE EVALUATED. PULSATILE AND RESISTIVE INDEXES, ATHEROSCLEROTIC CHANGES IN CAROTID ARTERIES (MEASURED BY DUPLEX ULTRASOUND), AND ARTERIAL STIFFNESS [MEASURED BY ENDO-PAT 2000 AS THE AUGMENTATION INDEX STANDARDIZED FOR HEART RATE (AI AT 75)] WERE EVALUATED 3 AND 6 MONTHS AFTER LEFT VENTRICULAR ASSIST DEVICE (LVAD) IMPLANTATION. THE PULSATILITY INDEX MEASURED AT 3 MONTHS WAS POSITIVELY ASSOCIATED WITH INCREASED HAZARD RATIOS (HR) FOR CEREBROVASCULAR EVENTS [HR 9.8, 95% CONFIDENCE INTERVAL (CI) 1.62-59.42], WITH HR INCREASING AFTER ADDING AI AT 75 TO THE MODEL (HR 18.8, 95% CI 2.44-145.50). THE RISK OF CEREBROVASCULAR EVENTS IN LVAD RECIPIENTS IS ASSOCIATED WITH INCREASED PULSATILITY INDEX IN CAROTID ARTERIES AND POTENTIATED BY INCREASED ARTERIAL STIFFNESS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1915482 | HEARTMATE 3 LEFT VENTRICULAR ASSIST DEVICE | VENTRICULAR (ASSISST) BYPASS | DSQ | THORATEC CORPORATION | 106523INT |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Other |