IMPELLA 5.5
Report
- Report Number
- 1220648-2025-46115
- Event Type
- Death
- Date Received
- September 3, 2025
- Date of Event
- August 4, 2025
- Report Date
- October 13, 2025
- Manufacturer
- ABIOMED, INC.
- Product Code
- OZD
- UDI-DI
- 00813502012828
- PMA / PMN Number
- P140003
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
H6 CODES HAVE BEEN UPDATED.
B5 UPDATED WITH UPDATED CLINICAL NARRATIVE. THE INVESTIGATION IS STILL ONGOING.
CORRECTED INFORMATION WAS PROVIDED IN D4 (CATALOG), AND D4 (SERIAL NUMBER). UPON REVIEW, THE SECTION D CATALOG AND SERIAL NUMBER HAVE NOW BEEN UPDATED. H6: UPDATED CODES BASED ON THE RESULTS OF THE INVESTIGATION. H11: UPDATED BASED ON THE RESULTS OF THE INVESTIGATION. THE ROOT CAUSE OF THE ACCESS SITE BLEEDING WAS NOT DETERMINED DUE TO LACK OF SUFFICIENT CLINICAL DETAILS AND UNRETURNED PRODUCT FOR FURTHER INVESTIGATION. THE CAUSE OF THE INJURY (MAJOR BLEED, HEMATURIA, HEMOPTYSIS) WAS NOT DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS. THE ROOT CAUSE OF THE INJURY (ISCHEMIA, VENTRICULAR FIBRILLATION) WAS UNABLE TO BE DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS.
SECTION H CODES HAVE BEEN UPDATED BASED ON ADDITIONAL INFORMATION. THIS REPORT REFLECTS THE MOST UP TO DATE CODING. CLINICAL ASSESSMENT: A 63-YEAR OLD MALE WITH A HISTORY OF CORONARY ARTERY DISEASE, MYOCARDIAL INFARCTION, HYPERTENSION, PERIPHERAL ARTERIAL DISEASE, PAROXYSMAL ATRIAL FIBRILLATION, AND ISCHEMIC CARDIOMYOPATHY WAS ADMITTED TO THE HOSPITAL FOR EVALUATION OF A POSSIBLE LEFT VENTRICULAR PSEUDOANEURYSM AND WITH COMPLAINTS OF CHEST PAIN CONCERNING FOR AN ANTERIOR ST SEGMENT ELEVATION MYOCARDIAL INFARCTION UNDER VENO-ARTERIAL EXTRACORPOREAL LIFE SUPPORT (VA-ECLS) AND INOTROPIC SUPPORT. AFTER AN OBSERVED LEFT VENTRICULAR THROMBUS DISAPPEARED, DECISION TO PLACE IMPELLA 5.5 VIA RIGHT AXILLARY ARTERY WAS MADE WITHOUT COMPLICATIONS AND BROUGHT ONTO THE INTENSIVE CARE UNIT (ICU). THE PLAN WAS TO BRIDGE THE PATIENT UNTIL HEART TRANSPLANT. AFTER 1 DAY ON THE ICU, PATIENT¿S WOUND VACUUM DRESSING KEEPS CLOTTING OFF AND LEAKING AROUND SITE THAT BIVALIRUDIN MUST HAVE BEEN PAUSED. DUE TO THE PATIENT WORSENING CONDITION, IT WAS PLANNED TO RECONFIGURE THE VA-ECLS CONFIGURATION TO A CENTRAL CANNULATION OR UPGRADE TO A RIGHT VENTRICULAR ASSIST DEVICE (RVAD), WHICH WAS THEN ACTUALLY DONE ON THE FIFTH DAY ON ICU BY ADDING THE DEVICE PROTEKDUO. AFTER 6 DAYS ON THE ICU, A BLOOD TRANSFUSION WITH PACKED RED BLOOD CELLS WAS GIVEN. ON DAY 7 ON THE ICU, URINE WAS DESCRIBED AS BEING RED/AMBER. AFTER BEDSIDE ECHO WAS DONE AND POSITION OF IMPELLA 5.5 PUMP CONFIRMED AS CORRECT, AND LACTATE DEHYDROGENASE WAS WITHIN THE NORM VALUES, THE CARE TEAM CONSIDERED THE CAUSE OF URINE COLOR TO BE HEMATURIA AND NOT IMPELLA RELATED. OVER THE NIGHT, URINE CLEARED WITHOUT INTERVENTION. ON THE TWELFTH DAY OF IMPELLA 5.5 SUPPORT, ON CT ONLY SMALL PLEURAL EFFUSIONS WERE SEEN BUT PATIENT HAD STILL SHORTNESS OF BREATH. ON DAY 15 OF SUPPORT, THE PATIENT¿S PNEUMONIA WORSENED AND ANTICOAGULATION WAS STILL ON HOLD. A DAY AFTER BLOODY SECRETIONS WERE RECOGNIZED. A DAY AFTER GASTROINTESTINAL BLEEDING WAS OBSERVED, WHICH WAS FILED AS THE FIRST COMPLAINT. THE GENERAL STATUS AGGRAVATED ANOTHER BLOOD TRANSFUSION WAS NECESSARY. ON DAY 18 OF IMPELLA 5.5 SUPPORT, THE PATIENT MUST HAVE BEEN INTUBATED AGAIN, INDICATING ANOTHER WORSENING OF HIS CONDITION. ALSO, A DAY AFTER BLEEDING WAS STILL PRESENT AND SOURCE COULD NOT BE FOUND. AFTER CLIPPING THE WOUND, PATIENT BECAME MORE STABLE, HOWEVER MILRINONE WAS STARTED. ON DAY 20 ECLS WAS DECANNULATED BUT SOME BLEEDING FROM INSERTION SITE WAS OBSERVED AND TARRY BLACK STOOLS. THE AUTOMATED IMPELLA CONTROLLER SHOWED. IMPELLA POSITION UNKNOWN, ECHO SHOWED A LITTLE SHALLOW, SO THE HEART PUMP WAS REPOSITIONED. AFTER 20 DAYS ON IMPELLA 5.5 SUPPORT, THE PATIENT AGAIN NEEDED A BLOOD TRANSFUSION AND REPOSITIONING. DISCUSSING POSSIBLE LVAD AFTER PSEUDO ANEURYSM SURGERY. LUNG FUNCTION DID NOT IMPROVE. AFTER 3 WEEKS, THE PATIENT SUFFERED FROM LIMB ISCHEMIA, THE FEET WERE MOTTLED (ANTICOAGULATION WAS STOPPED), WHICH WAS FILED AS THE SECOND COMPLAINT. AFTER 28 DAYS OF SUPPORT, THE PATIENT HAD VENTRICULAR ARRYTHMIAS. THE CARE TEAM PLANNED TO COVERT THE PROTEKDUO DEVICE CONFORMATION BUT COULD NOT BE CARRIED OUT FINALLY. DUE TO SUCTION EVENTS, THE DEVICE MUST HAVE BEEN REPOSITIONED TWICE. THE PATIENT GOT A PERCUTANEOUS ENDOSCOPIC GASTRONOMY (PRESUMABLY TO CHECK FOR FURTHER GASTROINTESTINAL BLEEDING). ON DAY 32 OF IMPELLA 5.5 SUPPORT, THE PATIENT WAS EXTUBATED BUT NEEDED MORE OF VASOPRESSORS. THE PATIENT SEEMED TO BE IN DELIRIUM. AFTER 33 DAYS OF SUPPORT THE PATIENT WAS BROUGHT TO THE OPERATING ROOM FOR CONFIGURATION CHANGE OF PROTEKDUO. AFTER 35 DAYS OF IMPELLA 5.5 SUPPORT THE FAMILY DECIDED TO LET THE PATIENT GOT, THE PATIENT DIED. IN THIS CRITICAL ILL PATIENT AND WITH A LONGER DURATION SUPPORT AS PER INSTRUCTION OF USE, A LOT A ADVERSE EVENTS WERE OBSERVED WHILE ON IMPELLA 5.5 SUPPORT, ALL OF THEM WERE CONSERVATIVELY CODED AS THERE WAS A TIMELY CONNECTION TO THIS DEVICE, HOWEVER ARE MORE LIKELY TO BE DUE TO THE SEVERITY OF THE PATIENT¿S COURSE OF DISEASE.. THE IMPELLA 5.5 WAS CODED FOR MINOR AND MAJOR BLEED, MEDICATION REQUIRED, HEMOLYSIS, ADDITIONAL DEVICE REQUIRED, ISCHEMIA AND VENTRICULAR FIBRILLATION. IN REGARD TO HEMOLYSIS, THE CARE TEAM CONSIDERED IT NOT RELATED TO THE HEART PUMP. LIMB ISCHEMIA OCCURRED DURING COMBINED SUPPORT OF VA-ECLS AND IMPELLA 5.5 ¿ IN LITERATURE LIMB ISCHEMIA IS MORE OFTEN DESCRIBED TO BE RELATED TO THE VA-ECLS THAN TO AXILLARY INSERTED IMPELLA 5.5. ADDITIONALLY, A SURGICAL INTERVENTION, 3 BLOOD TRANSFUSIONS AND MULTIPLE DEVICE REPOSITIONINGS OCCURRED. IMPELLA SUPPORT WAS CONTINUED BEYOND THE RECOMMENDED 14-DAY DURATION; PROLONGED USE CAN INCREASE THE RISK OF COMPLICATIONS AND THEREFORE MAY HAVE PLAYED A CONTRIBUTORY ROLE IN THIS ADVERSE EVENT. FINALLY, DEATH WAS CONSERVATIVELY CODED TO THE IMPELLA 5.5 WHILE MOST LIKELY TO BE CAUSED BY THE UNDERLYING DISEASE AND UNRELATED TO IMPELLA AS THE IMPELLA DEVICE FUNCTIONED AS EXPECTED IN THIS CRITICALLY ILL PATIENT.
PRODUCT COMPLAINT #: (B)(4).
THE INVESTIGATION FOR THE REPORTED VASCULAR INJURY AND ISCHEMIA HAS BEEN COMPLETED. THE DEVICE NOR SUFFICIENT CLINICAL INFORMATION WAS RETURNED FOR EVALUATION. THEREFORE, THE ROOT CAUSE OF THE VASCULAR INJURY AND ISCHEMIA COULD NOT BE DETERMINED.
IT CANNOT BE DETERMINED IF THE USE OF ANTICOAGULANT FOR USE OF THE IMPELLA DEVICE IMPACTED/EXACERBATED THE OUT OF THE BLEED FOR THE PATIENT. ADDITIONALLY, GIVEN THE IMPELLA RELATED EVENT OF LIMB ISCHEMIA THERE IS NOT ENOUGH INFORMATION TO DISSOCIATE THE DEVICE FROM THE DEMISE OUTCOME. DEVICE STATUS: THE IMPELLA DEVICE WAS NOT RECEIVED FROM THE CUSTOMER; THEREFORE, AN EVALUATION/ANALYSIS OF THE DEVICE WAS NOT POSSIBLE. SHOULD THE DEVICE OR ANY NEW INFORMATION BE RECEIVED, A SUPPLEMENTAL MDR WILL BE FILED.
THE COMPLAINANT REPORTED A PATIENT WITH CARDIOMYOPATHY WAS IMPLANTED WITH AN IMPELLA 5.5 DEVICE FOR MECHANICAL CIRCULATORY SUPPORT (MCS) AND EXPERIENCED GASTROINTESTINAL BLEEDING AND LIMB ISCHEMIA REQUIRING INTERVENTION. HOWEVER, THE PATIENT WOULD SUBSEQUENTLY EXPIRE. THE PATIENT WAS ADMITTED FOR POSSIBLE LEFT VENTRICULAR LV PSEUDO ANEURYSM AND COMPLAINT OF CHEST PAIN ANTERIOR ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION. VENO ARTERIAL EXTRACORPOREAL MEMBRANE OXYGENATION (VA ECMO) WAS CANNULATED AT BEDSIDE AFTER THE DECISION TO IMPLANT THE IMPELLA 5.5 DEVICE WAS DELAYED AS THE PATIENT DEVELOPED A LEFT VENTRICLE CLOT AND WAS NOTED ALLERGY TO HEPARIN. THE LEFT VENTRICLE CLOT DISSIPATED AND THEREAFTER THE DECISION WAS MADE TO PLACE THE IMPELLA 5.5 VIA THE RIGHT AXILLARY. THE PATIENT WAS SENT TO THE UNIT ON IMPELLA AND ECMO SUPPORT WITH THE PLAN TO REMAIN ON THESE THERAPIES UNTIL HEART TRANSPLANT. APPROXIMATELY 12 DAYS LATER THERE WERE CONCERNS REGARDING THE PATIENT¿S LUNGS AS THE PATIENT WAS FAILING WEAN TRIALS OF OXYGENATOR. COMPUTED TOMOGRAPHY (CT) OF THE LUNGS WAS COMPLETED AND NOTHING SIGNIFICANT SHOWED UP. HOWEVER, THE PATIENT DID GO BACK FOR ANOTHER CT AS THE PATIENT WAS NOT IMPROVING AND WAS STILL HAVING SHORTNESS OF BREATH. HEMOPTYSIS WAS NOTED. ANTICOAGULANTS REMAINED ON HOLD DUE TO BLOODY SECRETIONS. THE NEXT COUPLE OF DAYS IT WAS NOTED THAT THE PATIENT HAD GASTROINTESTINAL BLEEDING. THE PATIENT RECEIVED ONE UNIT OF PACKED RED BLOOD CELLS. ANTICOAGULATION REMAINED OFF. THE NEXT DAY, THE PATIENT¿S FEET WERE MOTTLED, AND THE PATIENT WAS ACTIVELY BLEEDING; SOURCE UNKNOWN. THREE ENDOSCOPIC CLIPS WERE PLACED FOR THE GASTROINTESTINAL BLEED. ECMO WAS DECANNULATED THE FOLLOWING DAY. NOW DAY 26 OF SUPPORT, THE PATIENT HAD A HEMOGLOBIN OF 6.7 G/DL AND RECEIVED ONE UNIT OF RED BLOOD CELLS. THE PATIENT REMAIN INTUBATED THIS TIME (NOTED: THE PATIENT WAS INTUBATED/EXTUBATED 5-6 TIMES ALREADY). THE IMPELLA WAS REPOSITIONED DUE TO SUCTION ALARMS AND NO ISSUES WITH SUCTION WAS NOTED POST REPOSITIONING. THE PATIENT WOULD CONTINUE IMPELLA MCS AND LUNGS WERE NOTED STILL NOT DOING WELL. EVENTUALLY, THE PATIENT WOULD EXPIRE 8 DAYS LATER. CARE WAS WITHDRAWN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 417639 | IMPELLA 5.5 | TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP | OZD | ABIOMED, INC. | IMPELLA 5.5 | 2026689354 | 00813502012828 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |