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	Restricted Flow rate (1248)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/19/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The impella device was not received from the customer and therefore, an evaluation of the device was not possible.Upon investigation closure, a supplemental mdr will be filed.
Event or Problem Description
A notification was received via abiomed¿s long-term outcome and quality indicator (loqi) impella registry regarding, the complainant reported a 62-year-old male patient with right heart failure was implanted with an impella rp device for mechanical circulatory support.The impella rp was supporting for 2 weeks when the pump was explanted.The team reported low flows with possible clot entrainment.There was no noted treatment for the low flows despite explant.
Additional Manufacturer Narrative
The investigation into low pump flow has been completed.The impella device was not returned for evaluation.The cause of the low pump flow issue was most likely biomaterial, based on data log review.G1 reporting contact email was reported incorrectly on manufacturer device report 1220648-2024-22343.

• 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 ; 22 cherry hill dr.; danvers, MA 01923
• MDR Report Key: 20630876
• Report Number: 1220648-2024-22343
• Device Sequence Number: 18120005
• Product Code: PYX
• UDI-Device Identifier: 00813502011029
• UDI-Public: (01)00813502011029(10)2023204373(17)240228
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Study,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/12/2024

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: 02/28/2024
• Device Model Number: IMPELLA RP
• Device Catalogue Number: 004334
• Device Lot Number: 2023204373
• 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: 10/14/2024
• Supplement Date Received by Manufacturer: 11/25/2024
• Initial Report FDA Received Date: 11/07/2024
• Supplement Report FDA Received Date: 12/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/16/2022
• 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: 62 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White