MAUDE Adverse Event Report: ABIOMED, INC. IMPELLA RP FLEX; TEMPORARY NON-ROLLER TYPE RIGHT HEART SUPPORT BLOOD PUMP

Model Number	IMPELLA RP
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient had successful percutaneous coronary intervention to the left main/left anterior descending artery.However during the course of the procedure, it was identified that there was a need for right ventricle support.The decision for an impella rp flex was made.However, they were unable to place the impella rp flex due to anatomy concerns.
Additional Manufacturer Narrative
The impella device was not received from the customer.Therefore, the investigation of the device was not possible.Should the device or any new information be received, a supplemental report will be filed.As noted in the impella instructions for use: impella rp flex with smartassist system with automated impella controller 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.¿ section: warnings & cautions: warnings, ¿do not advance or withdraw the impella rp flex with smartassist system catheter against resistance without using fluoroscopy to determine the cause of the resistance.Doing so could result in separation of the catheter or guidewire tip, damage to the catheter or vessel, or perforation.¿.
Additional Manufacturer Narrative
The investigation of the reported failure mode has been completed.No product was received for evaluation.Unable to deliver or advance (delivery issue): the cause of the deliver issue was determined to be patient condition as the patient had difficult anatomy preventing successful delivery of impella.Device history review: the device passed all post sterile inspection checks.

• Brand Name: IMPELLA RP FLEX
• Common Device Name: TEMPORARY NON-ROLLER TYPE RIGHT HEART SUPPORT BLOOD PUMP
• Manufacturer (Section D): ABIOMED, INC.; 22 cherry hill drive; danvers MA 01923
• Manufacturer Contact: derek sammarco ; 22 cherry hill drive; danvers, MA 01923 ; 7814934967
• MDR Report Key: 23551952
• Report Number: 1220648-2025-48348
• Device Sequence Number: 9718695
• Product Code: PYX
• UDI-Device Identifier: 00813502011869
• UDI-Public: (01)00813502011869(10)2025442264(17)251130
• 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: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup

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: 11/30/2025
• Device Model Number: IMPELLA RP
• Device Catalogue Number: 0046-0035
• Device Lot Number: 2025442264
• 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: 10/17/2025
• Supplement Date Received by Manufacturer: 11/26/2025
• Initial Report FDA Received Date: 11/14/2025
• Supplement Report FDA Received Date: 12/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/11/2024
• 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 Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White