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	Unspecified Vascular Problem (4441)
Date of Event	07/25/2025
Type of Reportable Event	Death
Additional Manufacturer Narrative
This mdr is being submitted as part of a retrospective review of optical signal issues in accordance with fda recommendation.Product was not returned for investigation.Data logs were investigated.When the pump is started, the cvp/ optical sensor readings drops and goes into negative.The snr dropped at the same time.This suggests that the pump's strut (optical sensor area) was against the patient's anatomy which creates a local suction.This cannot be confirmed sine the product has not been returned for investigation.Therefore, the root cause of the optical signal issue was not determined since product was not returned to conclude anything.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.
Event or Problem Description
The complainant reported that an impella rp pump was implanted in a patient presented with heart failure for circulatory support.During support the pump triggered intermittent 'placement signal not reliable' alarms.At the time of the noted call, the displayed placement signal was within normal limits and positioning was confirmed via chest x-ray.The staff was advised that the signal was not required for support and the alarm was silenced.The family made the decision to withdraw care and the patient expired.

• 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: ralph barisano ; 22 cherry hill dr.; danvers, MA 01923
• MDR Report Key: 23102599
• Report Number: 1220648-2025-31600
• Device Sequence Number: 20768811
• Product Code: PYX
• UDI-Device Identifier: 00813502011869
• UDI-Public: (01)00813502011869(10)2024385433(17)250731
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: P170011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• 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: 07/31/2025
• Device Model Number: IMPELLA RP
• Device Catalogue Number: 0046-0035
• Device Lot Number: 2024385433
• 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: 07/25/2025
• Initial Report FDA Received Date: 09/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/11/2023
• 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: 54 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic