MAUDE Adverse Event Report: ABIOMED, INC. - 1220648 RP W SMART ASSIST SET, US; TEMPORARY NON-ROLLER TYPE RIGHT HEART SUPPORT BLOOD PUMP

Catalog Number	0046-0035
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	Heart Failure/Congestive Heart Failure (4446)
Date of Event	11/26/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by abiomed inc, or its employees that the report constitutes an admission that the product, abiomed inc, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
A 48-year-old male with a history of heart failure and cardiogenic shock underwent implantation of an impella 5.5 for left-sided mechanical circulatory support.Given the extent of cardiogenic shock and concerns for right ventricular failure, the heart team proceeded with an attempt to implant an impella rp with smartassist (rpsa) via the femoral vein to provide right-sided mechanical circulatory support.During the procedure, the team was unable to advance the impella rpsa catheter across the right heart and into the pulmonary artery.The attempt was unsuccessful due to: significant vessel tortuosity, preventing advancement to appropriate pulmonary artery position.Given the inability to safely advance the device, the impella rp was removed.The heart team planned to proceed with placement of an impella rp flex via an alternative access site better suited for the patient¿s anatomy remained supported by impella 5.5 after unsuccessful rp implant.Plans made to pursue rp flex placement for right-sided mechanical circulatory support via alternative access.No hemodynamic instability or adverse events reported from the unsuccessful rpsa attempt.

• Brand Name: RP W SMART ASSIST SET, US
• Common Device Name: TEMPORARY NON-ROLLER TYPE RIGHT HEART SUPPORT BLOOD PUMP
• Manufacturer (Section D): ABIOMED, INC. - 1220648; 22 cherry hill drive; danvers MA 01923
• Manufacturer Contact: derek sammarco ; 22 cherry hill drive; danvers, MA 01923 ; 7814934967
• MDR Report Key: 24547535
• Report Number: 1220648-2026-04789
• Device Sequence Number: 13071371
• Product Code: PYX
• UDI-Device Identifier: 00813502011869
• UDI-Public: (01)00813502011869(17)260131(10)2025462425
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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

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: 01/31/2026
• Device Catalogue Number: 0046-0035
• Device Lot Number: 2025462425
• 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: 11/26/2025
• Initial Report FDA Received Date: 03/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/21/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 48 YR
• Patient Sex: Male
• Patient Weight: 98 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White