MAUDE Adverse Event Report: ABIOMED, INC. IMPELLA 5.0; TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP

Model Number	IMPELLA 5.0
Medical Device Problem Code	Restricted Flow rate (1248)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	10/11/2021
Type of Reportable Event	Death
Event or Problem Description
The complainant reported a patient in post cardiotomy cardiogenic shock¿and with low cardiac output syndrome, with an open chest for a surgical ablation, mitral and aortic valve replacement, and aortic root aneurysm repair, was implanted with an impella 5.0 for mechanical circulatory support.It was reported while on impella 5.0 support, the patient experienced bleeding from the procedures that required the patient to be transfused with 7 units of blood, 2 units of platelets, and 2 units of factor vii.The patient's coagulation studies were reported as normal, however the patient continued to bleed from their chest tubes.The patient's chest was reopened to investigate the source of bleeding, but the source was unable to be located.The physician was not concerned with the impella as a contributing factor for the bleeding.The patient was transferred back to the icu on impella support, where shortly after arriving, the impella flows continued to reduce with frequent suction alarms.The patient expired while on support.Given the limited information surrounding the details the patient's condition and cause of death the impella cannot be excluded as a possible contributing factor, however, the patient's condition may be more likely have impacted the event.
Additional Manufacturer Narrative
H4 date of manufacturer 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.
Additional Manufacturer Narrative
The investigation for the reported issue has been completed.Due to the limited clinical information and lack of available data/product the root cause of this investigation is not determined.This report is being filed as part of a retrospective review of historical records.

• Brand Name: IMPELLA 5.0
• 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
• MDR Report Key: 20812305
• Report Number: 1220648-2024-24413
• Device Sequence Number: 15937807
• Product Code: OZD
• UDI-Device Identifier: 00813502011180
• UDI-Public: (01)00813502011180(10)1465640(17)220131
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/06/2025

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2022
• Device Model Number: IMPELLA 5.0
• Device Catalogue Number: 005062-RO
• Device Lot Number: 1465640
• 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: 10/11/2021
• Supplement Date Received by Manufacturer: 11/29/2024
• Initial Report FDA Received Date: 11/29/2024
• Supplement Report FDA Received Date: 10/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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; Death
• Patient Age: 63 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White