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	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Cardiovascular Dysfunction/Insufficiency (4445)
Date of Event	07/07/2021
Type of Reportable Event	Death
Event or Problem Description
The user facility reported a patient with post cardiotomy cardiogenic shock / low cardiac output syndrome was going to be on an impella 5.0 for mechanical circulatory support.It was reported that the impella 5.0 was unable to be fully utilized, the patient's axillary was too small for the delivery of the 5.0 device.The physician decided to remove the device and replace it with an impella cp.The exchange resulted in loss of mechanical circulatory support to the patient at a critical time.The patient expired the next day; care was withdrawn.Although more likely the patient expired as a result of the cardiac event, the issue with the impella 5.0 device cannot be excluded as a contributing factor in the overall outcome for this event.
Additional Manufacturer Narrative
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.

• 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 ; 22 cherry hill dr.; danvers, MA 01923
• MDR Report Key: 20813851
• Report Number: 1220648-2024-24467
• Device Sequence Number: 21317428
• Product Code: OZD
• UDI-Device Identifier: 00813502011180
• UDI-Public: (01)00813502011180(10)1499590(17)220731
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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
• Report Date (Section B): 11/30/2024

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: 07/31/2022
• Device Model Number: IMPELLA 5.0
• Device Catalogue Number: 005062-RO
• Device Lot Number: 1499590
• 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: 07/07/2021
• Initial Report FDA Received Date: 11/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/30/2020
• 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: 76 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White