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	12/05/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The complainant reported that an impella rp pump was implanted in a patient admitted for mitral valve and right ventricle failure.The rp had lost optical signal within hours of placement.The patient was additionally implanted with an impella 5.5 pump.The rp remained on for patient support until explantation.
Additional Manufacturer Narrative
This mdr is being submitted as part of a retrospective review of optical signal issues in accordance with fda recommendation.Pump was not returned for investigation.The data log shows several #1053 and #1055 placement signal not reliable (snr) alarms at the start of the case run, with low snr and contrast observed in the optical signal parameters.As per the clinical details, the pump had intermittent psnr alarms at the start of the case.Some blood was given to the patient.The cause of the optical signal issue was most likely patient condition related based on data log review.A review of the device history record (dhr) for the suspect device, applicable quality notifications, and historical complaint data was conducted.This review revealed that the product met all manufacturing release criteria, and no product deficiencies were identified at the time product was manufactured and released to the customer.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: 23059326
• Report Number: 1220648-2025-31470
• Device Sequence Number: 9503820
• Product Code: PYX
• UDI-Device Identifier: 00813502011869
• UDI-Public: (01)00813502011869(10)2024395779(17)250131
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/15/2025

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: 01/31/2025
• Device Model Number: IMPELLA RP
• Device Catalogue Number: 0046-0035
• Device Lot Number: 2024395779
• 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: 12/05/2023
• Initial Report FDA Received Date: 09/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/02/2023
• Is the Device Labeled for Single Use? (Y/N): No
• 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: 66 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White