MAUDE Adverse Event Report: ABIOMED, INC. - 1220648 IMPELLA; TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP

Catalog Number	0052-3046
Medical Device Problem Codes	Fluid/Blood Leak (1250); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	03/25/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
An impella cp device was inserted into the right femoral artery in a 56-year-old male patient 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 bailout of a protected percutaneous coronary intervention (pci).During the procedure, there was bleeding at the diaphragm of the 14fr sheath.It is unknown if treatment was required.While the patient was in the intensive care unit (icu), there was a drop in hemoglobin requiring blood transfusions.The patient received multiple blood products and albumin to assist with volume resuscitation.It was reported that the physician did not attribute the event to the impella.Two days after impella insertion, the device was successfully removed.The post-procedure outcome is survived at explant.The impella functioned at p-3 at 1.8l/min as intended.Bleeding is a known risk due to the impella's anticoagulation and purge requirements.
Additional Manufacturer Narrative
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 Manufacturer Narrative
Removed a24 from h6 and added a050401 to h6.The investigation is still ongoing.
Additional Manufacturer Narrative
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.Fluid leak/major bleed: since insufficient clinical details were provided and product wasn't returned for investigation, the cause of the fluid leak could not be determined.

• Brand Name: IMPELLA
• Common Device Name: TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP
• Manufacturer (Section D): ABIOMED, INC. - 1220648; 22 cherry hill drive; danvers MA 01923
• Manufacturer Contact: derek sammarco ; 22 cherry hill drive; danvers, MA 01923 ; 7814934967
• MDR Report Key: 24775630
• Report Number: 1220648-2026-06339
• Device Sequence Number: 12295567
• Product Code: OZD
• UDI-Device Identifier: 00813502011678
• UDI-Public: (01)00813502011678(17)280630(10)S10020641
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P140003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/22/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 0052-3046
• Device Lot Number: S10020641
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/25/2026
• Supplement Date Received by Manufacturer: 04/20/2026; 05/21/2026
• Initial Report FDA Received Date: 04/03/2026
• Supplement Report FDA Received Date: 04/22/2026; 05/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/04/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 56 YR
• Patient Sex: Male
• Patient Weight: 106 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White