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	Device Sensing Problem (2917)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/12/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The complainant reported that an impella 5.5 and impella rp pump were implanted as bipella support in a patient for circulatory support.While on bipella support, after a coughing event and a turn; a patient signal not reliable alarm on the impella rp occurred.Flow stayed the same with no change in patient or pump performance.There was no reported harm or injury to the patient.
Additional Manufacturer Narrative
This report is being submitted as part of a retrospective review of optical signal issues, per fda recommendation.The investigation of the optical signal issue has been completed.The cause of the optical signal issue was not determined since the product was not returned and sufficient clinical information was not provided.All pertinent information available to abiomed has been submitted at this time.

• 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 MA 01923
• Manufacturer Contact: derek sammarco ; 22 cherry hill dr.; danvers, MA 01923
• MDR Report Key: 23092681
• Report Number: 1220648-2025-31572
• Device Sequence Number: 9681178
• Product Code: PYX
• UDI-Device Identifier: 00813502011869
• UDI-Public: (01)00813502011869(10)2023199492(17)230930
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 09/18/2025

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: 09/30/2023
• Device Model Number: IMPELLA RP
• Device Catalogue Number: 0046-0035
• Device Lot Number: 2023199492
• 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: 09/12/2023
• Initial Report FDA Received Date: 09/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/24/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: AUTOMATED IMPELLA CONTROLLER.
• Patient Age: 47 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White