IMPELLA 5.5
Report
- Report Number
- 1220648-2025-27711
- Event Type
- Death
- Date Received
- April 21, 2025
- Date of Event
- January 20, 2025
- Report Date
- September 25, 2025
- Manufacturer
- ABIOMED, INC.
- Product Code
- OZD
- UDI-DI
- 00813502011630
- PMA / PMN Number
- P140003
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SP
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
THE INVESTIGATION OF INFECTION/SEPSIS, STROKE/CVA, VASCULAR DAMAGE - PERIPHERAL VESSEL, THROMBUS, AND THROMBOCYTOPENIA HAVE BEEN COMPLETED. DATA LOGS ARE NOT AVAILABLE. PRODUCT WAS RETURNED AND EVALUATED. THE PUMP'S 5S PARAMETERS WERE WITHIN SPECIFICATION. THE PUMP PASSED LASER CONTINUITY TESTING. AS THE NECESSARY INFORMATION WAS NOT PROVIDED, THE ROOT CAUSE OF INFECTION/SEPSIS, STROKE/CVA, VASCULAR DAMAGE - PERIPHERAL VESSEL, THROMBUS, AND THROMBOCYTOPENIA WAS NOT DETERMINED.
THE IMPELLA DEVICE WAS RETURNED, AND AN EVALUATION IS UNDERWAY. UPON INVESTIGATION CLOSURE, A SUPPLEMENTAL MANUFACTURER DEVICE REPORT WILL BE FILED. AS NOTED IN THE IMPELLA INSTRUCTIONS FOR USE: IMPELLA 5.5 WITH SMARTASSIST FOR USE DURING CARDIOGENIC SHOCK. SECTION: TABLE 3.2 IMPELLA CATHETER COMPONENTS. ¿THE INFUSION FILTER PREVENTS BACTERIAL CONTAMINATION AND AIR FROM ENTERING THE PURGE LUMEN.¿ SECTION: WARNINGS & CAUTIONS: WARNINGS: ¿TO REDUCE THE POSSIBILITY OF FIBERS BEING DRAWN INTO THE IMPELLA, CUSTOMERS SHOULD AVOID EXPOSING THE INLET AND CANNULA SECTION OF THE IMPELLA HEART PUMPS TO ANY SURFACES OR FLUID BATHS WHERE THE DEVICE CAN COME INTO CONTACT WITH LOOSE OR FLOATING FIBERS.¿ SECTION: POTENTIAL ADVERSE EVENTS (UNITED STATES): ¿ACUTE RENAL DYSFUNCTION, AORTIC VALVE INJURY, BLEEDING, CARDIOGENIC SHOCK, CEREBRAL VASCULAR ACCIDENT/STROKE, DEATH, HEMOLYSIS, LIMB ISCHEMIA, MYOCARDIAL INFARCTION, RENAL FAILURE, THROMBOCYTOPENIA AND CARDIAC OR VASCULAR INJURY (INCLUDING VENTRICULAR PERFORATION).¿ SECTION: WARNINGS, CAUTIONS & PRECAUTIONS: ¿TO REDUCE THE POSSIBILITY OF FIBERS BEING DRAWN INTO THE IMPELLA, CUSTOMERS SHOULD AVOID EXPOSING THE INLET AND CANNULA SECTION OF THE IMPELLA HEART PUMPS TO ANY SURFACES OR FLUID BATHS WHERE THE DEVICE CAN COME INTO CONTACT WITH LOOSE OR FLOATING FIBERS.¿ SECTION: WARNINGS & CAUTIONS: WARNINGS: SECTION: PRE-SUPPORT EVALUATION, SECTION: AXILLARY INSERTION OF THE IMPELLA 5.5 CATHETER, SECTION: DIRECT AORTIC INSERTION, SECTION: USE OF IMPELLA WITH TRANSCATHETER AORTIC VALVES: "IN PATIENTS WITH TRANSCATHETER AORTIC VALVES POSITION THE IMPELLA SYSTEM CAREFULLY TO AVOID INTERACTION WITH THE TRANSCATHETER AORTIC VALVE PROSTHESIS. UNINTENTIONAL INTERACTION OF THE IMPELLA MOTOR HOUSING WITH THE TAVR DEVICE MAY RESULT IN DESTRUCTION OF THE IMPELLER BLADES. THIS CAN LEAD TO SYSTEMIC EMBOLIZATION, SERIOUS INJURY, OR DEATH." . IN THIS SITUATION, AVOID REPOSITIONING WHILE THE DEVICE IS RUNNING; TURN THE DEVICE TO P0 DURING REPOSITIONING OR ANY MOVEMENT THAT COULD BRING THE OUTLET WINDOWS INTO PROXIMITY TO THE VALVE STENT STRUCTURES. IF THERE IS LOW FLOW OBSERVED IN A PATIENT IMPLANTED WITH A TRANSCATHETER AORTIC VALVE PROSTHESIS, CONSIDER DAMAGE OF THE IMPELLER AND REPLACE THE IMPELLA AS SOON AS POSSIBLE.¿
THIS REPORT IS BEING SUBMITTED AS PART OF A RETROSPECTIVE REVIEW OF OPTICAL SIGNAL ISSUES, PER FDA RECOMMENDATION. THE INVESTIGATION HAS BEEN COMPLETED FOR OPTICAL SIGNAL ISSUE: PRODUCT WAS RETURNED AND EVALUATED. THE PUMP'S 5S PARAMETERS WERE WITHIN SPECIFICATION. THE PUMP PASSED LASER CONTINUITY TESTING. THE ROOT CAUSE OF THE OPTICAL SIGNAL ISSUE WAS NOT DETERMINED SINCE DATA LOGS WERE NOT AVAILABLE TO ANALYZE THE SENSOR'S BEHAVIOR DURING THE CASE. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR THE SUSPECT PRODUCT AND HISTORICAL COMPLAINT DATA WAS CONDUCTED. THIS REVIEW REVEALED THAT THE PRODUCT MET ALL MANUFACTURING RELEASE CRITERIA, AND NO PRODUCT DEFICIENCIES WERE IDENTIFIED AT THE TIME THE PRODUCT WAS MANUFACTURED AND RELEASED TO THE CUSTOMER. ALL PERTINENT INFORMATION AVAILABLE TO ABIOMED HAS BEEN SUBMITTED AT THIS TIME. B1 PRODUCT PROBLEM UPDATED. B5 UPDATED TO INCLUDE OPTICAL SIGNAL ISSUE DESCRIPTION. H6 UPDATED TO INCLUDE OPTICAL SIGNAL CODING. CORRECTIONS THAT WERE MADE FROM THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2025-27711. B7 OTHER RELEVANT HISTORY, INCLUDING PREEXISTING MEDICAL CONDITIONS UPDATED. D10 CONCOMITANT MEDICAL PRODUCTS AND THERAPY DATES UPDATED.
ON APRIL 1ST, 2025, THE VIGILANCE UNIT OF MEDICAL DEVICES OF THE SPANISH AGENCY OF MEDICINES AND MEDICAL DEVICES HAS BEEN INFORMED THROUGH RENACER REGISTRY ABOUT AN INCIDENT. ON (B)(6) 2025 THE PATIENT ON IMPELLA 5.5 SUPPORT DEVELOPED HEPARIN INDUCED THROMBOCYTOPENIA AND WAS SWITCHED FROM HEPARIN TO ARGATROBAN. ON (B)(6) 2025 NON-CENTRAL NERVOUS SYSTEM ARTERIAL THROMBOEMBOLISM AND MAJOR INTRA-ABDOMINAL HEMORRHAGE OCCURRED. ANTICOAGULATION WAS DISCONTINUED AND LEFT BICARBONATE IN THE PURGE. THERE WAS SPONTANEOUS BLEEDING FROM BRANCHES OF THE HEPATIC ARTERY WITH HYPOVOLEMIC SHOCK. ATTEMPTED EMBOLIZATION BY INTERVENTIONAL RADIOLOGY WAS NOTED. ON (B)(6) 2025 THE PATIENT SUFFERED AN ISCHEMIC STROKE WITH SYMPTOMS BUT THERE WAS NO SIGNIFICANT DISABILITY. ANTICOAGULATION WAS RESUMED. OCCIPITAL STROKE WITHOUT SEQUELAE. RECOVERED WITHOUT SEQUELAE. ON (B)(6) 2025 THE PATIENT HAD KLEBSIELLA PNEUMONIAE INFECTION AND SEPTIC SHOCK AND EXPIRED TWO DAYS LATER.
THE COMPLAINANT ALSO REPORTED THAT THE IMPELLA 5.5 OPTICAL SENSOR STOPPED WORKING. FLOWS AND MOTOR CURRENT WERE CONFIRMED TO BE ACCURATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1518491 | IMPELLA 5.5 | TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP | OZD | ABIOMED, INC. | IMPELLA 5.5 | 2025579395 | 00813502011630 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 55 YR | Male | Death| R | AUTOMATED IMPELLA CONTROLLER |