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	Increase in Pressure (1491)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/13/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation into the reported issue has been completed.Data logs of the incorrect pump were sent.Additionally, only the cannula with the motor housing was returned for investigation; the remainder of the impella was cut off at the catheter.A small amount of biomaterial was observed around part of the purge gap; otherwise, no damage or abnormalities were found on the returned product.However, the nature of the returned product was insufficient to definitively determine the root cause.Therefore, the cause of the high purge pressure was unable to be determined.This report is being filed as part of a retrospective review of historical records.
Event or Problem Description
The complainant reported a patient was implanted with an impella device for mechanical circulatory support.The clinical team reported that recurrent "high purge pressure" alarms with low purge flow occurred during impella support.Attempting to troubleshoot the issue, the team decreased the pump speed to p-0 and then immediately returned it to p-7, which successfully improved the purge flow.However, the purge flow rate trended downwards over the next 24 hours, which led to the use of the same intervention again.It was noted that the purge flow never exceeded 5 ml/hr throughout support.Activated clotting time (act) was asserted to be in normal therapeutic range.No patient harm was reported.

• 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.
• MDR Report Key: 20931303
• Report Number: 1220648-2024-24777
• Device Sequence Number: 12039109
• Product Code: OZD
• UDI-Device Identifier: 00813502011180
• UDI-Public: (01)00813502011180(10)2022052315(17)230131
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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): 12/13/2024

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: 01/31/2023
• Device Model Number: IMPELLA 5.0
• Device Catalogue Number: 005062
• Device Lot Number: 2022052315
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/13/2024
• Initial Report FDA Received Date: 12/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/24/2021
• 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: 62 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White