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
Event or Problem Description
The complainant reported that an impella rp pump was implanted to support a patient post-op to cardiothoracic surgery.It was reported that there was an unreliable placement signal sensor during use of the device.Support continued despite this issue.As there was no concern from the team.No further information was provided.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 confirm the negative cvp as well as the placement signal not reliable alarms.The alarm code specified that the optical sensor was out of range during the time period this alarm was triggered.It is also noted that there are multiple suction alarms during this time.The suction alarms and the placement signal unreliable alarms resolve at the same time.All of the 5s parameters show that the sensor is functioning, the signal is just dampened by an increase in noise as a result of the suction conditions.The root cause of the optical signal issue was most likely patient condition as the pump was experiencing suction the time of the event.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: ralph barisano ; 22 cherry hill dr.; danvers, MA 01923
• MDR Report Key: 23097546
• Report Number: 1220648-2025-31588
• Device Sequence Number: 9225849
• Product Code: PYX
• UDI-Device Identifier: 00813502011869
• UDI-Public: (01)00813502011869(10)2023193945(17)230930
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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: 09/30/2023
• Device Model Number: IMPELLA RP
• Device Catalogue Number: 0046-0035
• Device Lot Number: 2023193945
• 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: 04/13/2022
• 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
• Outcome Attributed to Adverse Event: Death
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White