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 Codes	Failure to Advance (2524); Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/07/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The impella device was not received from the customer, therefore, evaluation of the device was not possible.The investigation into the delivery/removal issue has been completed.The root cause of the delivery issues was determined to be patient condition per clinical detail review as the patient had calcified and stenotic vessel.Additionally, it was noted that there was a red lumen removal issue.The cause was the component.This report is being filed as part of a retrospective review of historical records.
Event or Problem Description
The user facility reported a patient with cardiomyopathy was going to be on an impella 5.0 for mechanical circulatory support.During delivery, the physician had difficulty advancing the pump once coming out of the sheath due to patient disease (calcium/stenosis).It was noted that the red lumen was reportedly sticking to the guidewire as it was advancing, and the red lumen was cut.An attempt to deliver the impella 2.5 was made but it would not advance out of the sheath due to calcification ad stenosis of the vessel.The physician decided to abort the implant.No further information is available.

• 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
• MDR Report Key: 20780785
• Report Number: 1220648-2024-24200
• Device Sequence Number: 5053044
• Product Code: OZD
• UDI-Device Identifier: 00813502011081
• UDI-Public: (01)00813502011081(10)1491150(17)220731
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P140003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• 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): 11/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/22/2022
• Device Model Number: IMPELLA 2.5
• Device Catalogue Number: 005042-RO
• Device Lot Number: 1491150
• 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: 03/07/2022
• Initial Report FDA Received Date: 11/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Patient Age: 79 YR
• Patient Sex: Female