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

Model Number	IMPELLA RP
Medical Device Problem Code	Failure to Sense (1559)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/30/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The complainant reported a patient in right ventricular failure was implanted with an impella rp device for mechanical circulatory support.The patient had a previous impella cp implanted and escalated to an impella 5.5 for increased support on (b)(6) 2022.The patient was then bridged to a durable left ventricular assist device on (b)(6) 2022.The patient was later found to be in right ventricular failure and the decision was made to place the impella rp.It was reported that during impella rp placement, there was an alarm for ¿flow calculation disabled¿ and failed a manual zero attempted.The insertion was aborted and a new impella rp was successfully placed.There was no patient harm reported.
Additional Manufacturer Narrative
The returned data logs indicate a raw placement signal (ps) of around 100 mmhg, and a displayed ps fluctuating around -200 mmhg and out of range.Since the raw ps appeared in range, the logs did not indicate any mechanical or electrical issues with the sensor voltage reading itself.Since the displayed ps was unreliable, it indicates a communication issue between the raw signal input and the readout from the epm.Thus, the root cause of the dp sensor failure is due to a communication issue.However, the exact communication issue cannot be pinpointed without the pump returned.This report is being filed as part of a retrospective review of historical records.
Additional Manufacturer Narrative
D4: udi information and expiration date was provided.H4: device manufacture date was provided.

• Brand Name: IMPELLA RP
• Common Device Name: TEMPORARY NON-ROLLER TYPE RIGHT 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 NY 01923
• Manufacturer Contact: derek sammarco
• MDR Report Key: 20956396
• Report Number: 1220648-2024-24871
• Device Sequence Number: 12658588
• Product Code: PYX
• UDI-Device Identifier: 00813502011029
• UDI-Public: (01)00813502011029(10)1484873(17)210831
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P170011
• 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,Followup
• Report Date (Section B): 09/16/2025

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: 08/31/2021
• Device Model Number: IMPELLA RP
• Device Catalogue Number: 004334
• Device Lot Number: 1484873
• 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: 03/30/2022
• Supplement Date Received by Manufacturer: 05/12/2022
• Initial Report FDA Received Date: 12/17/2024
• Supplement Report FDA Received Date: 09/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/30/2019
• 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: 63 YR
• Patient Sex: Male
• Patient Race: White