IMPELLA
Report
- Report Number
- 1220648-2026-07208
- Event Type
- Injury
- Date Received
- April 29, 2026
- Date of Event
- April 9, 2026
- Manufacturer
- ABIOMED, INC. - 1220648
- Product Code
- OZD
- UDI-DI
- 00813502012279
- PMA / PMN Number
- P140003
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
MAJOR BLEED WAS INITIALLY CODED AGAINST THE PUMP WHILE AWAITING ADDITIONAL INFORMATION REGARDING INTRODUCER. PER ADDITIONAL INFORMATION RECEIVED AND DOCUMENTED IN 1220648-2026-07208-2, THE SHEATH WAS LEFT IN. HENCE, THE BLEED WILL NOW BE CODED AGAINST THE INTRODUCER. SEE 1220648-2026-08276 FOR INVESTIGATION OF THE INTRODUCER.
CORRECTED INFORMATION WAS PROVIDED IN D3 (MANUFACTURER FAX). UPON REVIEW, IT WAS IDENTIFIED THAT IT WAS INADVERTENTLY OMITTED FROM THE INITIAL REPORT. CORRECTED INFORMATION WAS PROVIDED IN D4 (PRIMARY UDI NUMBER). UPON REVIEW, THE SECTION D PRIMARY UDI NUMBER HAS NOW BEEN UPDATED. H6: UPDATED CODES BASED ON THE RESULTS OF THE INVESTIGATION. H11: UPDATED BASED ON THE RESULTS OF THE INVESTIGATION. THE ROOT CAUSE OF THE INJURY WAS UNABLE TO BE DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS. THE CAUSE OF THE BLEEDING AT THE ACCESS SITE WAS NOT DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS.
D4. CATALOG AND SERIAL CORRECTED. H6. MEDICAL DEVICE PROBLEM CODE A24 ADVERSE EVENT WITHOUT IDENTIFIED DEVICE OR USE PROBLEM REMOVED AND REPLACED WITH A01 PATIENT DEVICE INTERACTION PROBLEM.,
B5 UPDATED WITH ADDITIONAL INFORMATION.
A4 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.
ADDITIONAL INFORMATION RECEIVED STATING THAT THE PEEL-AWAY INTRODUCER WAS STILL IN PLACE AND WAS UNAWARE OF AN INTERVENTIONS PERFORMED. THE ITEMS ARE NOT AVAILABLE FOR RETURN.
AN IMPELLA CP DEVICE WAS INSERTED INTO THE RIGHT FEMORAL ARTERY IN A 49-YEAR-OLD MALE PATIENT WITH A PAST MEDICAL HISTORY OF DIABETES, PRESENTING IN ACUTE MYOCARDIAL INFARCTION (AMI) AND CARDIOGENIC SHOCK (CGS), IN AN OUT-OF-HOSPITAL CARDIAC ARREST REQUIRING CARDIOPULMONARY RESUSCITATION (CPR), IN SCAI STAGE E SHOCK, ON MULTIPLE INOTROPES AND VASOPRESSORS, AND ON A VENTILATOR FOR RESPIRATORY SUPPORT, PRIOR TO INITIATION OF SUPPORT. THE IMPELLA WAS INSERTED FOR VENTRICULAR SUPPORT FOR A PROTECTED PERCUTANEOUS CORONARY INTERVENTION (PCI). DURING THE PROCEDURE, THERE WAS OOZING AROUND THE SHEATH AND OTHER ACCESS SITES. THE PHYSICIAN WAS AWARE, NO INTERVENTION ORDERS GIVEN. WHILE THE PATIENT WAS IN THE INTENSIVE CARE UNIT (ICU), THE PATIENT EXPERIENCED VENTRICULAR TACHYCARDIA (VT), WITH A DROPPING BLOOD PRESSURE AND HEART RATE. LIDOCAINE IV AND ALBUMIN 250 ML'S WERE GIVEN, WHICH RESOLVED THE ISSUE. THE PATIENT WAS TRANSFERRED TO ANOTHER HOSPITAL FOR A HIGHER LEVEL OF CARE. AFTER THREE DAYS AND 21 HOURS ON SUPPORT, THE DEVICE WAS SUCCESSFULLY WEANED. THE POST-PROCEDURE OUTCOME IS SURVIVED AT EXPLANT. THE IMPELLA FUNCTIONED AT P-2 AT 1.7 L/MIN AS INTENDED. BLEEDING IS A KNOWN RISK DUE TO THE IMPELLA'S ANTICOAGULATION AND PURGE REQUIREMENTS. ARRYTHMIAS MAY BE INFLUENCED BY PATIENT-SPECIFIC FACTORS SUCH AS CRITICAL ILLNESS, UNDERLYING CARDIAC DYSFUNCTION, AND HEMODYNAMIC INSTABILITY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 557689 | IMPELLA | TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP | OZD | ABIOMED, INC. - 1220648 | 2026808674 | 00813502012279 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |