MAUDE Adverse Event Report: Abiomed, Inc. - 1220648 Impella; Temporary Non-Roller Type Right Heart Support Blood Pump

Catalog Number	1000323
Medical Device Problem Code	Device Sensing Problem (2917)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/08/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Clinical narrative: impella rp flex smartassist was inserted via right internal jugular vein in a 65-year-old male patient presenting with acute decompensated chronic cardiomyopathy.The patient¿s comorbidities were not documented.The patient¿s clinical state prior to initiation of support was society for cardiovascular angiography and interventions (scai) shock stage was not documented.The scai stage at pump insertion was stage e.Stage e patients have hypoperfusion and organ failure despite numerous interventions according to the scai shock algorithm; associated with high mortality.After 2 days of support, the hospital team reported a placement signal not reliable (psnr) alarm.No intervention was performed in response to the alarm, and the pump remained and provided hemodynamic support.The psnr alarm did not result in interruption of support, loss of flow, or other reported adverse clinical consequences.During support, the impella rp flex smartassist functioned at performance level p-7 with flow of 4.2 l/min utilizing 5% dextrose in water with heparin in the purge solution, which is a higher flow than expected.On day 4 of support, a decision was made to withdraw care and the patient expired.The mean arterial pressure documented on the day of the psnr event was 63 mmhg.No additional hemodynamic parameters or pump performance data were reported for days 3 and 4 of support.Based on the available clinical information, the patient's death was likely attributable to progression of the underlying cardiogenic shock.The patient presented at pump insertion in scai stage e shock.The device provided the intended hemodynamic support and there was no interruption of therapy.Therefore, the device is not considered a contributing factor to the patient outcome.
Additional Manufacturer Narrative
A4.Weight is unknown.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.

• Brand Name: Impella
• 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 (Section G): Danvers
• Manufacturer Contact: derek sammarco ; 22 cherry hill drive; danvers, MA 01923 ; +1(781)493-4967
• MDR Report Key: 50773125
• Report Number: 1220648-2026-12885
• Device Sequence Number: 13367655
• Product Code: PYX
• UDI-Device Identifier: 00813502012811
• UDI-Public: (01)00813502012811(17)280531(10)2027918019
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: P170011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

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 Catalogue Number: 1000323
• Device Lot Number: 2027918019
• 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: 09/08/2026
• Initial Report FDA Received Date: 09/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/12/2026
• 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: 65 YR
• Patient Sex: Male
• Patient Race: White