IMPELLA CP SMART ASSIST SET, EU
Report
- Report Number
- 1220648-2026-04398
- Event Type
- Death
- Date Received
- March 3, 2026
- Date of Event
- February 23, 2026
- Manufacturer
- ABIOMED, INC. - 1220648
- Product Code
- OZD
- UDI-DI
- 04260113630280
- PMA / PMN Number
- P140003
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THIS IS ONE OF TWO RELATED REPORTS. THIS REPORT REPRESENTS THE SECOND IMPELLA CP AND ANOTHER REPORT WILL BE SUBMITTED TO REPRESENT THE FIRST IMPELLA CP. 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. D4. SERIAL AND PRIMARY UDI NUMBER CORRECTED. H6: INVESTIGATION: TYPE, FINDINGS, CONCLUSION CODES AND H6 COMPONENT CODES WERE UPDATED ACCORDINGLY BASED ON THE COMPLETED INVESTIGATION. THE DEVICE WAS NOT RETURNED; THEREFORE, AN EVALUATION/ANALYSIS OF THE DEVICE WAS NOT POSSIBLE. THE CAUSE OF THE ACCESS SITE ADVERSE EVENT WAS NOT DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS.
ADDITIONAL INFORMATION WAS RECEIVED, AND AN UPDATED CLINICAL ASSESSMENT WAS COMPLETED AND DOCUMENTED IN SECTION B5 (EVENT DESCRIPTION). THE INFORMATION ALSO CONFIRMS THAT THE IMPELLA PUMP PLACED FOR SUPPORT WAS EXPLANTED. THE PATIENT WAS SUBSEQUENTLY REPORTED TO HAVE EXPIRED, AND SECTION D6B HAS BEEN UPDATED ACCORDINGLY (WITH D6A REPOPULATED). FOLLOWING THE CLINICAL ASSESSMENT, THE REPORTABLE EVENT CLASSIFICATION WAS REVISED TO DEATH FROM SERIOUS INJURY. AS A RESULT, SECTIONS B1 (ADVERSE EVENT/PRODUCT PROBLEM), B2 (OUTCOMES ATTRIBUTED), AND H1 (TYPE OF REPORTABLE EVENT) WERE UPDATED. NOTE: THE ACTUAL DATE OF DEATH IS NOT KNOWN AT THE TIME OF THIS FOLLOW-UP REPORT. A PROVISIONAL DATE, BASED ON THE EXPLANT DATE, HAS BEEN RECORDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON RECEIPT OF THE CONFIRMED DATE OF DEATH OR ANY NEW, RELEVANT INFORMATION.
CLINICAL REVIEW/RATIONALE: AN IMPELLA CP WAS INSERTED VIA FEMORAL ARTERY OF UNKNOWN SIDE IN A 48 YEAR OLD MALE WHO WAS ADMITTED FOR ACUTE MYOCARDIAL INFARCTION WITH CARDIOGENIC SHOCK. THE PATIENT¿S COMORBIDITIES WERE UNKNOWN. THE PATIENT¿S CLINICAL STATE PRIOR TO INITIATION OF SUPPORT WAS SCAI STAGE D. ON DAY 2 OF SUPPORT, THE INITIAL IMPELLA CP WAS EXCHANGED FOR A NEW IMPELLA CP VIA THE SAME ACCESS SITE. WHILE IN THE INTENSIVE CARE UNIT, BLEEDING WAS REPORTED FROM THE ACCESS SITE. A FEMSTOP AND MANUAL PRESSURE WERE APPLIED, BUT UNSUCCESSFUL AT STOPPING THE BLEED. PERCLOSE WAS NOT ATTEMPTED DUE TO STERILITY CONCERNS. VESSEL REPAIR WAS PERFORMED WITH A VASCULAR PATCH, AND THE PATIENT RECEIVED UNKNOWN AMOUNT OF BLOOD TRANSFUSION. VASCULAR INJURY IS A KNOWN RISK ASSOCIATED WITH IMPELLA CP AS DESCRIBED IN THE INSTRUCTIONS FOR USE.
ADDITIONAL INFORMATION RECEIVED FROM A CLINICAL REVIEW REPORTS AN IMPELLA CP DEVICE WAS INSERTED VIA FEMORAL ARTERY OF UNKNOWN SIDE IN A 48 YEAR OLD MALE WHO WAS ADMITTED FOR ACUTE MYOCARDIAL INFARCTION WITH CARDIOGENIC SHOCK. THE PATIENT¿S COMORBIDITIES WERE UNKNOWN. THE PATIENT¿S CLINICAL STATE PRIOR TO INITIATION OF SUPPORT WAS SCAI STAGE D. ON DAY 2 OF SUPPORT, THE INITIAL IIMPELLA CP WAS EXCHANGED FOR A NEW IMPELLA CP VIA THE SAME ACCESS SITE. WHILE IN THE INTENSIVE CARE UNIT, BLEEDING WAS REPORTED FROM THE ACCESS SITE. A FEMSTOP AND MANUAL PRESSURE WERE APPLIED, BUT UNSUCCESSFUL AT STOPPING THE BLEED. PERCLOSE WAS NOT ATTEMPTED DUE TO STERILITY CONCERNS. VESSEL REPAIR WAS PERFORMED WITH A VASCULAR PATCH, AND THE PATIENT RECEIVED UNKNOWN AMOUNT OF BLOOD TRANSFUSION. THE REPORTED ACCESS-SITE BLEEDING REQUIRING SURGICAL VASCULAR REPAIR IS CONSISTENT WITH VASCULAR INJURY AND LARGE-BORE ARTERIAL ACCESS COMPLICATIONS IN THE SETTING OF ANTICOAGULATION AND IMPELLA SUPPORT. BLEEDING VASCULAR INJURY ARE CONSISTENT WITH ACCESS SITE COMPLICATIONS AS A RESULT OF LARGE BORE FEMORAL PROCEDURES AND THE ANTICOAGULATION AND PURGE REQUIREMENTS ASSOCIATED WITH IMPELLA SUPPORT. CARE WAS WITHDRAWN AND THE PATIENT EXPIRED. THE DEATH IS BEING CONSERVATIVELY REPORTED; HOWEVER, THE OUTCOME IS MOST CONSISTENT WITH THE PATIENT¿S UNDERLYING ACUTE MYOCARDIAL INFARCTION, CARDIOGENIC SHOCK (SCAI STAGE D), HEMODYNAMIC INSTABILITY, AND COMPLICATIONS RELATED TO SEVERE CRITICAL ILLNESS, INCLUDING SIGNIFICANT BLEEDING REQUIRING SURGICAL INTERVENTION AND TRANSFUSION.
AN IMPELLA CP WAS INSERTED VIA FEMORAL ARTERY OF UNKNOWN SIDE IN A 48-YEAR-OLD MALE WHO WAS ADMITTED FOR ACUTE MYOCARDIAL INFARCTION WITH CARDIOGENIC SHOCK. THE PATIENT¿S COMORBIDITIES WERE UNKNOWN. THE PATIENT¿S CLINICAL STATE PRIOR TO INITIATION OF SUPPORT WAS SCAI STAGE D. ON DAY 2 OF SUPPORT, THE INITIAL IMPELLA CP WAS EXCHANGED FOR A NEW IMPELLA CP VIA THE SAME ACCESS SITE. WHILE IN THE INTENSIVE CARE UNIT, BLEEDING WAS REPORTED FROM THE ACCESS SITE. A FEMSTOP AND MANUAL PRESSURE WERE APPLIED, BUT UNSUCCESSFUL AT STOPPING THE BLEED. PERCLOSE WAS NOT ATTEMPTED DUE TO STERILITY CONCERNS. VESSEL REPAIR WAS PERFORMED WITH A VASCULAR PATCH, AND THE PATIENT RECEIVED UNKNOWN AMOUNT OF BLOOD TRANSFUSION. BLEEDING VASCULAR INJURY ARE CONSISTENT WITH ACCESS SITE COMPLICATIONS AS A RESULT OF LARGE BORE FEMORAL PROCEDURES AND THE ANTICOAGULATION AND PURGE REQUIREMENTS ASSOCIATED WITH IMPELLA SUPPORT. THE DEVICE WAS LATER EXPLANTED AT THE END OF UNIT SUPPORT, AND THE PATIENT EXPIRED. THE DEVICE IS UNLIKELY TO HAVE CONTRIBUTED TO THE PATIENT¿S DEATH, WHICH WAS MOST LIKELY RELATED TO THE PATIENT¿S UNDERLYING CRITICAL CLINICAL CONDITION AS THEY PRESENTED WITH SCAI SHOCK STAGE D.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 281762 | IMPELLA CP SMART ASSIST SET, EU | TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP | OZD | ABIOMED, INC. - 1220648 | 2025580651 | 04260113630280 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 48 YR | Male | Life Threatening| D| R |