MAUDE Adverse Event Report: ABIOMED, INC. IMPELLA RP; TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP

Model Number	IMPELLA RP
Medical Device Problem Code	Device Sensing Problem (2917)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/15/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The complainant reported the device's placement signal failing after patient was rolled during a procedure.Patient expired while on support.
Additional Manufacturer Narrative
This mdr is being submitted as part of a retrospective review of optical signal issues in accordance with fda recommendation.The data logs were reviewed and a placement signal not reliable alarm triggered with ps spiking to 3000 mmhg for 1 hour and then the alarm resolved and placement signal (ps) returned to normal.Throughout the run, ps was trending up and shifting down.The cause of the issue was not determined since product was not returned.All pertinent information available to abiomed has been submitted at this time.

• Brand Name: IMPELLA RP
• 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: 23097363
• Report Number: 1220648-2025-31587
• Device Sequence Number: 21162513
• Product Code: PYX
• UDI-Device Identifier: 00813502011029
• UDI-Public: (01)00813502011029(10)2022124648(17)230731
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P170011
• 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): 09/19/2025

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: 07/31/2023
• Device Model Number: IMPELLA RP
• Device Catalogue Number: 004334
• Device Lot Number: 2022124648
• 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: 04/15/2023
• Initial Report FDA Received Date: 09/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/06/2021
• 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
• Outcome Attributed to Adverse Event: Death
• Patient Age: 71 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian