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	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/06/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation for the reported delivery issue has been completed.The impella device was not received from the customer and therefore, an evaluation of the device was not possible.However, clinical details provided were sufficient to determine a root cause.The cause of the delivery issue was patient condition related due to the stenosis in iliac.
Event or Problem Description
The complainant reported a patient in acute myocardial infarction/cardiogenic shock was being implanted with an impella 2.5 device for mechanical circulatory support.It was reported the complainant reported that impella met resistance in the stenosed area of the iliac artery.After multiple attempts to pass the stenosis the case was aborted and the 2.5 was explanted through the peel away sheath.

• 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: 20749986
• Report Number: 1220648-2024-23817
• Device Sequence Number: 15544336
• Product Code: OZD
• UDI-Device Identifier: 00813502011081
• UDI-Public: (01)00813502011081(10)2023196793(17)231130
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: P140003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• 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): 11/21/2024

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: 11/30/2023
• Device Model Number: IMPELLA 2.5
• Device Catalogue Number: 005042-RO
• Device Lot Number: 2023196793
• 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: 10/06/2023
• Initial Report FDA Received Date: 11/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/22/2022
• 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: 78 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White