IMPELLA 5.5 WITH SMARTASSIST S2 SET, US
Report
- Report Number
- 1220648-2026-01619
- Event Type
- Injury
- Date Received
- January 27, 2026
- Date of Event
- January 15, 2026
- Manufacturer
- ABIOMED, INC. - 1220648
- Product Code
- OZD
- UDI-DI
- 813502012828
- PMA / PMN Number
- P140003
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
B3: CORRECTED EVENT DATE.
B3: CORRECTED EVENT DATE. H6: ADDED CODES BASED ON NEW INFORMATION IN THE COMPLAINT FILE. CLINICAL REVIEW: FOLLOWING THE HEART TRANSPLANT (HTX), THE PHYSICIAN NOTED AN ORGANIZED THROMBUS ON THE INLET CAGE OF THE IMPELLA 5.5. THE PATIENT WAS PLACED ON BYPASS, AND THE IMPELLA WAS REMOVED DURING THE TRANSPLANT. THE THROMBUS IS MOST LIKELY RELATED TO THE PATIENT¿S SEVERE CARDIOGENIC SHOCK AND THE ALTERED HEMODYNAMIC ENVIRONMENT ASSOCIATED WITH PROLONGED SUPPORT, BOTH OF WHICH CAN PREDISPOSE TO THROMBUS FORMATION. DEVICE-RELATED FLOW CHARACTERISTICS MAY ALSO CONTRIBUTE, AS THROMBUS IS A KNOWN POTENTIAL RISK DOCUMENTED IN THE INSTRUCTIONS FOR USE.
PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: THROMBOSIS: THE CAUSE OF THE INJURY WAS NOT DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS. HEMOLYSIS/MECHANICAL INTERACTION WITH BLOOD: THE CAUSE OF HEMOLYSIS WAS NOT DETERMINED DUE TO NO PRODUCT OR DATA LOGS RETURNED. DEVICE HISTORY LOT: DEVICE LOT: 2022501. DEVICE HISTORY BATCH: SUBCOMPONENT LOT: N/A. DEVICE HISTORY REVIEW: THE PUMP SN (B)(6) PASSED ALL THE POST STERILE INSPECTION CHECKS.
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.
SECTION B5 AND D6B WAS UPDATED BASED ON ADDITIONAL INFORMATION.
CLINICAL RATIONALE AN IMPELLA 5.5 DEVICE WAS INSERTED VIA THE RIGHT AXILLARY ARTERY IN A 57-YEAR-OLD MALE PATIENT PRESENTING WITH CARDIOMYOPATHY AND A MEDICAL HISTORY SIGNIFICANT FOR PRIOR CORONARY ARTERY BYPASS GRAFTING (CABG), KNOWN CORONARY ARTERY DISEASE (CAD), DIABETES MELLITUS, AND RENAL INSUFFICIENCY, IN THE SETTING OF SCAI STAGE E CARDIOGENIC SHOCK. DURING SUPPORT, NURSING STAFF REPORTED CONCERN FOR HEMOLYSIS BASED ON RED-TINGED URINE WITH A PLASMA-FREE HEMOGLOBIN (PFHB) OF 26 WHILE THE PUMP WAS OPERATING AT P8. SUPPORT SETTINGS WERE ADJUSTED, AND PUMP FLOWS WERE REDUCED TO P6, AFTER WHICH HEMOLYSIS CONCERNS RESOLVED. THE PATIENT REMAINED ON IMPELLA SUPPORT. THE HEMOLYSIS IS MOST LIKELY ATTRIBUTED TO DEVICE-RELATED FLOW CONDITIONS AND HEMODYNAMIC FACTORS RELATED TO THE PATIENT'S UNDERLYING CRITICAL CONDITION. HEMOLYSIS IS A KNOWN RISK IN PATIENTS RECEIVING MECHANICAL CIRCULATORY SUPPORT AS DESCRIBED IN THE INSTRUCTIONS FOR USE.
ADDITIONAL INFORMATION RECEIVED THAT THE PUMP WAS EXPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 455631 | IMPELLA 5.5 WITH SMARTASSIST S2 SET, US | TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP | OZD | ABIOMED, INC. - 1220648 | 2026796198 | 813502012828 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR | Male | Other |