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	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/22/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The complainant reported that an impella rp was unable to pass through the right ventricle due to the patient¿s anatomy.The impella rp was exchanged for an impella rp flex successfully.
Additional Manufacturer Narrative
The impella device was discarded by the customer and therefore, an evaluation of the device was not possible.Should any new information be received, a supplemental manufacturer device report will be filed.As noted in the impella instructions for use: impella rp smart assist system with automated impella controller section: warnings & cautions: cautions.¿dilators and catheters should be removed slowly from the sheath.Rapid removal may damage the valve, resulting in blood flow through the valve.¿ section: warnings & cautions: warnings.¿to reduce the risk of cardiac or vascular injury (including perforation) when manipulating the heart during cardiac surgery, evaluate the position of the pump using imaging guidance prior to manipulating the heart, and monitor position.¿ ¿to reduce the risk of cardiac or vascular injury (including perforation) when manipulating the heart during cardiac surgery, evaluate the position of the pump using imaging guidance.¿ section: potential adverse events (united states).¿arrhythmia, atrial fibrillation, bleeding, cardiac tamponade, cardiogenic shock, death, device malfunction, hemolysis, hepatic failure, insertion site infection, perforation, phlegmasia cerulea dolens (a severe form of deep venous thrombosis), pulmonary valve insufficiency, respiratory dysfunction, sepsis, thrombocytopenia, thrombotic vascular (non-central nervous system complication, tricuspid valve injury, cardiac or vascular injury (including ventricular perforation), venous thrombosis, ventricular fibrillation and/or tachycardia.¿.
Additional Manufacturer Narrative
The investigation was completed and there was no product returned.The root cause of delivery issue is determined to be patient condition because the pump was unable to pas through rv due to difficult patient anatomy and later rp flex was inserted successfully.

• 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
• MDR Report Key: 22841164
• Report Number: 1220648-2025-31168
• Device Sequence Number: 4822863
• Product Code: PYX
• UDI-Device Identifier: 00813502011869
• UDI-Public: (01)00813502011869(10)2025523511(17)260531
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P170011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• 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): 09/11/2025

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: 05/31/2026
• Device Model Number: IMPELLA RP
• Device Catalogue Number: 0046-0035
• Device Lot Number: 2025523511
• 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: 07/22/2025
• Supplement Date Received by Manufacturer: 08/29/2025
• Initial Report FDA Received Date: 08/19/2025
• Supplement Report FDA Received Date: 09/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/20/2024
• 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: 76 YR
• Patient Sex: Male
• Patient Weight: 120 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American