IMPELLA
Report
- Report Number
- 1220648-2026-06219
- Event Type
- Injury
- Date Received
- April 1, 2026
- Date of Event
- March 23, 2026
- Manufacturer
- ABIOMED, INC. - 1220648
- Product Code
- OZD
- PMA / PMN Number
- P140003
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
B5: EVENT DESCRIPTION- ADDITIONAL INFORMATION ADDED. H6: HEALTH EFFECT - IMPACT CODE ADDED.
PPAE (ISCHEMIA/ CARDIAC ARREST / MAJOR BLEED) : THE ROOT CAUSE OF THE INJURY WAS UNABLE TO BE DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS. ADDITIONAL INFORMATION HAS BEEN PROVIDED IN H6 (COMPONENT CODE, INVESTIGATION FINDINGS, TYPE OF INVESTIGATION, AND INVESTIGATION CONCLUSIONS).
A5 IS UNKNOWN. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ABIOMED INC OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ABIOMED INC, OR ITS EMPLOYEES, CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.
B5. ADDITIONAL EVENT DESCRIPTION ADDED.
ADDITIONAL INFORMATION RECEIVED FROM THE COMPLAINANT REPORTING THE PATIENT WAS REVIEWED BY VASCULAR AND THEY CONFIRMED BIPHASIC FLOWS PLUS PEDAL PULSES ALTHOUGH DIFFICULT TO DETECT, THEY WERE PRESENT. WITH REGARDS TO BLEEDING, NOTE THIS WAS ABDOMINAL BLEEDING FOLLOWING CPR WITH (B)(6), AND NOT IMPLELLA RELATED THERE WAS BLOOD AND PLATELETS GIVEN. PATIENTS CS WAS RESOLVED AND IMPELLA WAS SUCCESSFULLY EXPLANTED IN THEATRES WITH VASCULAR SURGICAL TEAM.
AN IMPELLA CP DEVICE WAS INSERTED VIA THE RIGHT FEMORAL ARTERY IN A 76-YEAR-OLD MALE PATIENT PRESENTING WITH ACUTE MYOCARDIAL INFARCTION COMPLICATED BY CARDIOGENIC SHOCK (AMI/CGS), SCAI SHOCK STAGE C, WITH A HISTORY OF KNOWN CORONARY ARTERY DISEASE. POST-PROCEDURE IMAGING DEMONSTRATED ABSENT PEDAL PULSES IN THE RIGHT LOWER EXTREMITY. A VASCULAR SURGERY CONSULTATION WAS OBTAINED, WHICH CONFIRMED BIPHASIC FLOW; THE RECOMMENDATION WAS TO CONTINUE OBSERVATION WITH THE LIMB KEPT WARM WHILE MAINTAINING IMPELLA SUPPORT. ADDITIONAL CONTRIBUTING FACTORS INCLUDED THE EMERGENT NATURE OF IMPELLA INSERTION DURING PCI, PERFORMED WITHOUT A DIAGNOSTIC ANGIOGRAM OF THE RIGHT LOWER EXTREMITY; ULTRASOUND AND MICROPUNCTURE TECHNIQUES WERE USED. THE PATIENT EXPERIENCED ABDOMINAL BLEEDING WITH LOW BLOOD PRESSURES AND A HEMOGLOBIN DROP TO 7.5 G/DL; ABDOMINAL FLUID WAS NOTED ON CT IMAGING. DURING THE INITIAL PHASE OF PCI, THE PATIENT SUSTAINED CARDIAC ARREST AND CARDIOPULMONARY RESUSCITATION (CPR) WAS INITIATED. THE PATIENT ULTIMATELY STABILIZED AND SURVIVED TO EXPLANT. THE REPORTED ISCHEMIA IS CONSISTENT WITH ACCESS-RELATED LIMB PERFUSION COMPROMISE IN THE SETTING OF FEMORAL ARTERIAL CANNULATION, ACUTE CARDIOGENIC SHOCK, AND VASOCONSTRICTION DURING CRITICAL ILLNESS. THE REPORTED MAJOR BLEED IS CONSISTENT WITH BLEEDING COMPLICATIONS ASSOCIATED WITH EMERGENT VASCULAR ACCESS, SYSTEMIC ANTICOAGULATION, AND HEMODYNAMIC INSTABILITY DURING HIGH-RISK PCI AND MECHANICAL CIRCULATORY SUPPORT. THE REPORTED CARDIAC ARREST IS CONSISTENT WITH THE SEVERITY OF THE UNDERLYING AMI/CGS AND THE EXTREME PHYSIOLOGIC STRESS ENCOUNTERED DURING PCI.
ADDITIONAL INFORMATION RECEIVED REPORTING THE PUMP WAS DISCARDED FOLLOWING ITS REMOVAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 111835 | IMPELLA | TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP | OZD | ABIOMED, INC. - 1220648 | 2026682726 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |