MAUDE Adverse Event Report: ABIOMED, INC. IMPELLA 2.5; TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP

Model Number	IMPELLA 2.5
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Tachycardia (2095); Cardiovascular Dysfunction/Insufficiency (4445)
Date of Event	11/29/2021
Type of Reportable Event	Death
Additional Manufacturer Narrative
The date of patient death is unknown.The impella device was not received from the customer, therefore, investigation of the device was not possible.Should the device or any new information be received, a supplemental mdr will be filed.This report is being filed as part of a retrospective review of historical records.
Event or Problem Description
The user facility reported a patient in acute myocardial infarction/cardiogenic shock was on an impella 2.5 for mechanical circulatory support.During support, the patient was bleeding around the foley and from the mouth.Pt occasionally have runs of vt with coughing , doctor repositioned.A gastrointestinal bleed was also identified.Heparin was discontinued.Additional information noted the patient was made a do not resuscitate, care was withdrawn, and the patient expired.There is not enough information to exclude the impella device as an associated factor in the patient's demise.
Additional Manufacturer Narrative
This complaint has been identified as part of a retrospective review.Due to the limited clinical information and lack of available data/product the root cause of this investigation is not determined.Corrected information in sections a5, b2, b7, e1, g1, h1, and h2.

• Brand Name: IMPELLA 2.5
• Common Device Name: TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP
• Manufacturer (Section D): ABIOMED, INC.; 22 cherry hill dr.; danvers MA 01923
• Manufacturer (Section G): ABIOMED, INC.; 22 cherry hill dr.; danvers MA 01923
• Manufacturer Contact: derek sammarco ; 22 cherry hill dr.; danvers, MA 01923
• MDR Report Key: 20734185
• Report Number: 1220648-2024-23615
• Device Sequence Number: 21070205
• Product Code: OZD
• UDI-Device Identifier: 00813502011081
• UDI-Public: (01)00813502011081(10)2022039181(17)221130
• 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: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/22/2025

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: 11/30/2022
• Device Model Number: IMPELLA 2.5
• Device Catalogue Number: 005042
• Device Lot Number: 2022039181
• 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: 11/29/2021
• Supplement Date Received by Manufacturer: 01/28/2025
• Initial Report FDA Received Date: 11/20/2024
• Supplement Report FDA Received Date: 05/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/19/2021
• 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; Required Intervention
• Patient Age: 56 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American