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	Pumping Stopped (1503)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/22/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation for pump stop has been completed.The root cause of the high motor current pump was most likely ingested biomaterial.As noted in the impella instructions for use: impella rp with smartassist system section: using the automated impella controller with the impella catheter ¿achieving an act = 250 seconds prior to removing the dilator will help prevent a thrombus from entering the catheter and causing a sudden stop on startup.¿ section: using the automated impella controller with the impella rp with smartassist system catheter ¿unresolved purge pressure high alarm if not resolved by the recommendations provided, high purge pressure¿which triggers the ¿purge pressure high¿ alarm message¿could be an indication of a kink in the impella rp with smartassist system catheter.In this case, the motor is no longer being purged and may eventually stop.Monitor motor current and consider replacing impella rp with smartassist system catheter whenever a rise in motor current is seen.¿ impella rp smart assist system with automated impella controller section: warnings, cautions, and precautions ¿to reduce the possibility of fibers being drawn into the impella, customers should avoid exposing the inlet and cannula section of the impella heart pumps to any surfaces or fluid baths where the device can come into contact with loose or floating fibers.¿ impella rp smart assist system with automated impella controller section: troubleshooting the purge system ¿unresolved purge pressure high alarm if not resolved by the recommendations provided, high purge pressure¿which triggers the ¿purge pressure high¿ alarm message¿could be an indication of a kink in the impella rp with smartassist system catheter.In this case, the motor is no longer being purged and may eventually stop.Monitor motor current and consider replacing the impella rp with smartassist system catheter whenever a rise in motor current is seen.¿ section: warnings & cautions: warnings: ¿to reduce the possibility of fibers being drawn into the impella, customers should avoid exposing the inlet and cannula section of the impella heart pumps to any surfaces or fluid baths where the device can come into contact with loose or floating fibers.This report is being filed as part of a retrospective review of historical records.
Event or Problem Description
The complainant reported a patient in acute myocardial infarction/cardiogenic shock was implanted with an impella rp for mechanical circulatory support.It was reported the pump there were high purge pressure alarms and the pump stopped and was restarted multiple times.The case wrap up indicates the patient remained on impella support and was successfully weaned.

• 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: 20570754
• Report Number: 1220648-2024-21554
• Device Sequence Number: 12905246
• Product Code: PYX
• UDI-Device Identifier: 00813502011029
• UDI-Public: (01)00813502011029(10)2023182494(17)240229
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 10/30/2024

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: 02/29/2024
• Device Model Number: IMPELLA RP
• Device Catalogue Number: 004334
• Device Lot Number: 2023182494
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/22/2023
• Initial Report FDA Received Date: 10/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/10/2022
• 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: 56 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White