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

Catalog Number	0048-0045
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Bradycardia (1751); Cardiac Arrest (1762)
Date of Event	12/11/2024
Type of Reportable Event	Death
Event or Problem Description
An impella cp was inserted via the right femoral artery to support the 71 year old female patient admitted in after a st- elevation myocardial infarction, presenting in scai stage e shock.The patient had arrested in the field and been given cpr by the emergency services.The cp was placed and the cardiac team performed percutaneous coronary intervention.The patient was supported by the cp pump, vasopressin, and calcium chloride.The patient was being transferred from the catheterization lab, and became bradycardic and then went into pulseless electrical activity (pea) and was returned to the lab.Acls protocols were initiated and epinephrine was given but patient was unable to be resuscitated.The patient expired in the cath lab despite all efforts.The death is conservatively being reported to the impella cp but is unlikely related and is most likely attributed to patients underlying critical condition as they presented in scai stage e shock after a community arrest with cpr/acls, and with ongoing hemodynamic instability inclusive of pea and need for ongoing acls needs/interventions.
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
Corrected information was provided in d3.Upon review, it was identified that it was inadvertently omitted from the initial report.H6 component code, type of investigation, investigation findings, and investigation conclusions codes have been updated to reflect investigation closure.The root cause of the injury was unable to be determined due to insufficient clinical details.

• 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 (Section G): DANVERS
• Manufacturer Contact: derek sammarco ; 22 cherry hill dr.; danvers, MA 01923 ; 7814934967
• MDR Report Key: 25445375
• Report Number: 1220648-2026-08634
• Device Sequence Number: 5727725
• Product Code: OZD
• UDI-Device Identifier: 00813502011876
• UDI-Public: (01)00813502011876(17)260731(10)2025572964
• 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: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/09/2026

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 Expiration Date: 07/31/2026
• Device Catalogue Number: 0048-0045
• Device Lot Number: 2025572964
• 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: 05/29/2026
• Supplement Date Received by Manufacturer: 06/22/2026
• Initial Report FDA Received Date: 06/09/2026
• Supplement Report FDA Received Date: 06/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/04/2024
• 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: Death
• Patient Age: 71 YR
• Patient Sex: Female
• Patient Ethnicity: Hispanic
• Patient Race: White