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	Positioning Failure (1158); Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/28/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The complainant reported a patient noted as high risk percutaneous coronary intervention was implanted with an impella 2.5 device for mechanical circulatory support.It was reported just after delivering the impella 2.5 into the left ventricle, the pump was found to have shifted back across the valve.When attempts to re-cross the valve failed, the device was removed for a complete reinsertion attempt.However, after successfully crossing the valve a second time, the guidewire was caught within the pump and the pump was once again removed.Attempts to subsequently backload the pump over a third wire resulted in damage to the peel away sheath and the decision was made to use a new pump.Insertion with the new pump was successful without further issue.There was no harm to the patient.
Additional Manufacturer Narrative
The impella device was not received from the customer, therefore, investigation of the device was not possible.The evaluation into the delivery issue has been completed.The clinical details provided were sufficient to determine the root cause.The root cause of the positioning issues was wireless re-access due to improper technique by the end user.The impella device is not indicated for wireless re-access.This report is being filed as part of a retrospective review of historical records.

• 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
• Manufacturer Contact: derek sammarco
• MDR Report Key: 20778694
• Report Number: 1220648-2024-24202
• Device Sequence Number: 18400300
• Product Code: OZD
• UDI-Device Identifier: 00813502011081
• UDI-Public: (01)00813502011081(10)1502909(17)220930
• 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: 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: 09/30/2022
• Device Model Number: IMPELLA 2.5
• Device Catalogue Number: 005042-RO
• Device Lot Number: 1502909
• 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: 09/28/2022
• Initial Report FDA Received Date: 11/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/16/2020
• 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
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White