-
Report
- Report Number
- 1220648-2025-45996
- Event Type
- Death
- Date Received
- September 2, 2025
- Date of Event
- July 31, 2025
- Manufacturer
- ABIOMED, INC. - 1220648
- Product Code
- OZD
- UDI-DI
- 00813502012828
- PMA / PMN Number
- P140003
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AL, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
ADDITIONAL INFORMATION WAS RECEIVED, AND A CLINICAL ASSESSMENT WAS COMPLETED AND DOCUMENTED IN SECTION B5 (EVENT DESCRIPTION). CORRECTION: COMPLAINT/PATIENT AND PRODUCT EXPERIENCE CODING HAS BEEN REVISED TO MORE ACCURATELY REFLECT THE REPORTED EVENT. AS A RESULT, THE H6 HEALTH EFFECT ¿ CLINICAL/IMPACT AND MEDICAL DEVICE PROBLEM CODING HAS BEEN FULLY UPDATED AND SHOULD BE CONSIDERED THE REPRESENTATION OF THE REPORTED EVENT. RELATED REPORT NUMBER. THIS IS ONE OF TWO DEVICE REPORTS ASSOCIATED WITH THE EVENT. REFER TO H10 FOR THE RELATED REPORT NUMBER(S).
THE CLINICAL ASSESSMENT WAS UPDATED AND CORRECTED, AND THE CHANGES ARE REFLECTED IN SECTION B5 (EVENT DESCRIPTION), INCLUDING A REVISION TO THE REPORTABILITY ASSESSMENT FOR THE ASSOCIATED DEVICE. REFER TO SECTION H10 FOR THE RELATED REPORT NUMBER. NOTE: H6 HEALTH EFFECT-CLINICA/IMPACT AND MEDICAL DEVICE PROBLEM CODES REMAINED UNCHANGED AS PREVIOUSLY REPORTED AND HAVE BEEN INVESTIGATED. INVESTIGATION. THE DEVICE WAS NOT RETURNED; THEREFORE, EVALUATION AND ANALYSIS COULD NOT BE PERFORMED. A DEVICE HISTORY RECORD REVIEW WAS CONDUCTED AND CONFIRMED THE PUMP PASSED ALL POST STERILE INSPECTION CHECKS. THE CAUSE(S) OF THE REPORTED HEMOPTYSIS, RENAL FAILURE AND PAROXYSMAL ATRIAL FIBRILLATION COULD NOT BE DETERMINED DUE TO INSUFFICIENT CLINICAL INFORMATION. THE CAUSE OF THE OPTICAL SIGNAL ISSUE COULD NOT BE DEFINITIVELY DETERMINED AS NO HARD FAILURE OF THE OPTICAL SENSOR WAS OBSERVED, NO PRODUCT WAS RETURNED FOR EVALUATION, AND LIMITED CLINICAL DETAILS WERE PROVIDED. REGARDING THE LOW FLOWS THE CAUSE WAS LIKELY PATIENT CONDITION RELATED AS LOW FLOWS WERE OCCURRING THROUGHOUT SUPPORT WHILE PATIENT WAS ALSO ON EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) SUPPORT, AND NO MOTOR CURRENT SPIKES WERE OBSERVED TO INDICATE INGESTION. H6 COMPONENT CODING AND INVESTIGATION TYPE, FINDINGS AND CONCLUSION CODING HAVE BEEN UPDATED BASED ON THE COMPLETED INVESTIGATION. RELATED REPORT NUMBER(S). THIS IS ONE OF TWO DEVICE REPORTS RELATED TO THE EVENT. REFER TO SECTION H10 FOR THE RELATED REPORT NUMBER(S).
THE IMPELLA DEVICE WAS NOT RECEIVED FROM THE CUSTOMER, THEREFORE, INVESTIGATION OF THE DEVICE WAS NOT POSSIBLE. SHOULD THE DEVICE OR ANY NEW INFORMATION BE RECEIVED, A SUPPLEMENTAL MDR WILL BE FILED.
THE CAUSE OF THE OPTICAL SIGNAL ISSUE COULD NOT BE DEFINITIVELY DETERMINED AS NO HARD FAILURE OF THE OPTICAL SENSOR WAS OBSERVED, NO PRODUCT WAS RETURNED FOR EVALUATION, AND LIMITED CLINICAL DETAILS WERE PROVIDED. THE CAUSE OF THE LOW PUMP FLOW WAS LIKELY PATIENT CONDITION RELATED AS LOW FLOWS WERE OCCURRING THROUGHOUT SUPPORT WHILE PATIENT WAS ALSO ON ECMO SUPPORT, AND NO MOTOR CURRENT SPIKES WERE OBSERVED TO INDICATE INGESTION.
A 58-YEAR-OLD MALE PATIENT WAS TRANSFERRED FROM ANOTHER HOSPITAL WITH POST-CARDIOTOMY CARDIOGENIC SHOCK/LOW CARDIAC OUTPUT SYNDROME FOR CORONARY ARTERY BYPASS GRAFT (CABG) AS PART OF HIGH-RISK SURGERY WITH A MEAN ATRIAL PRESSURE OF 113 MMHG (UNDER MORE THAN 3 CATECHOLAMINE AND RESPIRATORY SUPPORT) AND PERIPHERAL VENO-ARTERIAL EXTRACORPOREAL LIFE SUPPORT (VA-ECLS) WITH AN ARTERIAL LACTATE OF 1.6 MMOL/L WITH A LEFT VENTRICULAR EJECTION FRACTION OF 28 MMHG IN SOCIETY FOR CARDIOVASCULAR ANGIOGRAPHY AND INTERVENTIONS SHOCK STAGE WITH A KNOWN HISTORY OF DIABETES MELLITUS TYPE II, HYPERTENSION, HYPERLIPIDEMIA AND NEUROPATHY. AFTER ANGIOGRAPHY, A SEVERE MULTI-VESSEL DISEASE WAS DIAGNOSED. 6 DAYS EARLIER ATHE PATIENT HAD A CABG FOR 4 VESSELS UNDER INTRA-AORTIC BALLOON PUMP (IABP) SUPPORT AND MINIMAL MEDICATION. ON DAY 2 AFTER THE CABG (DA 4 DAYS BEFORE THE CURRENT TRANSFER) THE IABP WAS REMOVED AS THE PATIENT DID WELL BUT DEVELOPED VENTRICULAR TACHYCARDIA WITH STORM AND WAS PLACED ON VA-ECLS. AFTER THE TRANSFER, THE PATIENT WAS PUT ON IMPELLA 5.5 (ACTIVATED CLOTTING TIME PRIOR TO THE IMPELLA 5.5 DEVICE WAS 314 SECONDS) AND TRANSFERRED TO VAV-ECLS AND PLANNED. ON THE FOURTH DAY OF IMPELLA 5.5 SUPPORT, THE INTENSIVISTS REMOVED AT BEDSIDE LARGE BLOOD CLOTS FROM RIGHT BRONCHI SEEN DURING BEDSIDE BRONCHOSCOPY EARLIER THIS MORNING. ON DAY SIX OF IMPELLA 5.5 SUPPORT, THE VOLUME WAS AGGRESSIVELY REMOVED TO START A SLOW WEAN OF VA-ECLS TO EVENTUALLY TRANSITION TO VV-ECLS. ALTHOUGH THE PATIENT REMAINED CRITICALLY ILL HE WAS STABLE AT DAY 8 OF IMPELLA 5.5 SUPPORT, SO EPINEPHRINE AND LEVOSIMENDAN WAS TRIED TO WEAN. ON DAY 9 OF SUPPORT, THE CARE TEAM NOTICED THE POOR LONGTERM PROGNOSIS. ANOTHER BRONCHOSCOPY ON DAY 11 OF IMPELLA 5.5 SUPPORT, SHOWED BLEEDING SUBSIDING IN THE AIRWAY. ON DAY 12 OF IMPELLA 5.5 SUPPORT ATRIAL FIBRILLATION OCCURRED DURING THE NIGHT, WHICH DICTATED INCREASE IN VASOPRESSOR SUPPORT AND PRECLUDED WEANING. A DAY AFTER HEPARIN WAS HELD WHILE CREATININE STARTED TO RISE AND URINE OUTPUT HAS DECREASED TO LESS THAN 100 CC/HOUR. ON DAY 15 OF IMPELLA 5.5 SUPPORT CONTINUOUS RENAL REPLACEMENT THERAPY WAS STARTED. ON DAY 16 OF IMPELLA 5.5 SUPPORT, THE LACTATE AND CREATININE IS INCREASING AND THE FURTHER PLAN WAS DISCUSSED WITH THE FAMILY PALLIATIVE CARE. FINALLY, THE FAMILY DECIDED TO WITHDRAW CARE, WHILE THE PUMP WAS NOT REMOVED FROM THE PATIENT. THE PATIENT¿S DECLINE AND EVENTUAL DEATH WERE CONSISTENT WITH THE SEVERITY OF UNDERLYING POST-CARDIOTOMY CARDIOGENIC SHOCK, AND RATHER NOT DEVICE RELATED.
A 58-YEAR-OLD MALE PATIENT WAS TRANSFERRED FROM ANOTHER HOSPITAL WITH POST-CARDIOTOMY CARDIOGENIC SHOCK/LOW CARDIAC OUTPUT SYNDROME FOR CORONARY ARTERY BYPASS GRAFT (CABG) AS PART OF HIGH-RISK SURGERY WITH A MEAN ATRIAL PRESSURE OF 113 MMHG (UNDER MORE THAN 3 CATECHOLAMINE AND RESPIRATORY SUPPORT) AND PERIPHERAL VENO-ARTERIAL EXTRACORPOREAL LIFE SUPPORT (VA-ECLS) WITH AN ARTERIAL LACTATE OF 1.6 MMOL/L WITH A LEFT VENTRICULAR EJECTION FRACTION OF 28 MMHG IN SOCIETY FOR CARDIOVASCULAR ANGIOGRAPHY AND INTERVENTIONS SHOCK STAGE WITH A KNOWN HISTORY OF DIABETES MELLITUS TYPE II, HYPERTENSION, HYPERLIPIDEMIA AND NEUROPATHY. AFTER ANGIOGRAPHY, A SEVERE MULTI-VESSEL DISEASE WAS DIAGNOSED. 6 DAYS EARLIER THE PATIENT HAD A CABG FOR 4 VESSELS UNDER INTRA-AORTIC BALLOON PUMP (IABP) SUPPORT AND MINIMAL MEDICATION. ON DAY 2 AFTER THE CABG (DA 4 DAYS BEFORE THE CURRENT TRANSFER) THE IABP WAS REMOVED AS THE PATIENT DID WELL BUT DEVELOPED VENTRICULAR TACHYCARDIA WITH STORM AND WAS PLACED ON VA-ECLS. AFTER THE TRANSFER, THE PATIENT WAS PUT ON IMPELLA 5.5 ON (B)(6) 2025 (ACTIVATED CLOTTING TIME PRIOR TO THE IMPELLA 5.5 DEVICE WAS 314 SECONDS) AND TRANSFERRED TO VAV-ECLS AND PLANNED. ON (B)(6) 2025 THE AIC CONNECTED TO THE PUMP ALSO EXPERIENCED OPTICAL SENSOR ISSUES REPORTED PLACEMENT SIGNAL NOT RELIABLE WITH AND WITHOUT PLACEMENT SIGNAL OCCURRED. ON THE FOURTH DAY OF IMPELLA 5.5 SUPPORT, THE INTENSIVISTS REMOVED AT BEDSIDE LARGE BLOOD CLOTS FROM RIGHT BRONCHI SEEN DURING BEDSIDE BRONCHOSCOPY EARLIER THIS MORNING. ON DAY SIX OF IMPELLA 5.5 SUPPORT, THE VOLUME WAS AGGRESSIVELY REMOVED TO START A SLOW WEAN OF VA-ECLS TO EVENTUALLY TRANSITION TO VV-ECLS. ALTHOUGH THE PATIENT REMAINED CRITICALLY ILL, HE WAS STABLE AT DAY 8 OF IMPELLA 5.5 SUPPORT, SO EPINEPHRINE AND LEVOSIMENDAN WAS TRIED TO WEAN. ON DAY 9 OF SUPPORT, THE CARE TEAM NOTICED THE POOR LONGTERM PROGNOSIS. ANOTHER BRONCHOSCOPY ON DAY 11 OF IMPELLA 5.5 SUPPORT, SHOWED BLEEDING SUBSIDING IN THE AIRWAY. ON DAY 12 OF IMPELLA 5.5 SUPPORT ATRIAL FIBRILLATION OCCURRED DURING THE NIGHT, WHICH DICTATED INCREASE IN VASOPRESSOR SUPPORT AND PRECLUDED WEANING. A DAY AFTER HEPARIN WAS HELD WHILE CREATININE STARTED TO RISE AND URINE OUTPUT HAS DECREASED TO LESS THAN 100 CC/HOUR. ON DAY 15 OF IMPELLA 5.5 SUPPORT CONTINUOUS RENAL REPLACEMENT THERAPY WAS STARTED. ON (B)(6) 2025, IT WAS REPORTED PERSISTENT SUCTION ALARMS. RN STATED THAT THEY ATTEMPTED TO DECREASE P-LEVELS TO BREAK SUCTION WITHOUT RESOLUTION. RN REPORTED WENT BACK TO P7 AND HAD GIVEN VOLUME, BLOOD, AND ALBUMIN. THE RN WAS ADVISED THAT THIS SUCTION COULD BE RELATED TO POSSIBLE BIVENTRICULAR DYSFUNCTION. RN STATED THAT THEY ARE TRYING TO WAIT FOR FAMILY ARRIVE THIS AM TO MAKE DECISIONS ON THE COURSE OF CARE. RN WAS SHOWN HOW DISABLE AUDIO FOR SUCTION IN THE MEANTIME. ON DAY 16 OF IMPELLA 5.5 SUPPORT, THE LACTATE AND CREATININE IS INCREASING AND THE FURTHER PLAN WAS DISCUSSED WITH THE FAMILY PALLIATIVE CARE. FINALLY, THE FAMILY DECIDED TO WITHDRAW CARE, WHILE THE PUMP WAS NOT REMOVED FROM THE PATIENT. THE DEATH IS CONSERVATIVELY BEING REPORTED. THE PATIENT¿S DECLINE AND EVENTUAL DEATH WERE CONSISTENT WITH THE SEVERITY OF UNDERLYING POST-CARDIOTOMY CARDIOGENIC SHOCK.
IT WAS REPORTED THAT WHILE IMPLANTED WITH AN IMPELLA 5.5 THE PATIENT EXPERIENCED OPTICAL SIGNAL LOSS AND SUCTION. THE PATIENT'S FAMILY DECIDED TO WITHDRAW CARE AND THE PATIENT EXPIRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 579643 | - | TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP | OZD | ABIOMED, INC. - 1220648 | IMPELLA 5.5 | 2025555903 | 00813502012828 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |