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

Catalog Number	1000323
Medical Device Problem Codes	Failure to Advance (2524); Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/31/2026
Type of Reportable Event	Death
Event or Problem Description
An impella rp flex was inserted percutaneously via right internal jugular vein access site in a 71-year-old female patient for post operative cardiothoracic surgery.The patient¿s comorbidities were coronary artery disease, diabetes.The patient¿s clinical state prior to support was society for cardiovascular angiography intervention (scai) shock stage was not reported.During the procedure, a guidewire was utilized and serial pre-dilation was performed.While advancing the impella rp flex through the superior vena cava/right atrial junction, resistance was encountered and the catheter continued to kink.The approximate insertion angle was reported as 30 degrees, and excessive force was applied in an attempt to advance the device.The location of resistance was reported as the inferior vena cava.Additional contributing factors included the patient's status as a surgical patient on cardiopulmonary bypass.The device was explanted 8 minutes after insertion and support was aborted.The patient subsequently expired.The patient subsequently expired.Based on the limited clinical information available, the patient's death is most likely attributable to the underlying cardiac condition and the inability to successfully establish impella rp flex support.Due to the limited details provided regarding the patient's clinical course, hemodynamic status, and cause of death, a causal relationship between the device event and the patient outcome cannot be definitively excluded.No additional intervention following device explant was reported.
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.

• 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 Contact: derek sammarco ; 22 cherry hill drive; danvers, MA 01923 ; +1(781)493-4967
• MDR Report Key: 50689735
• Report Number: 1220648-2026-12618
• Device Sequence Number: 20327584
• Product Code: PYX
• UDI-Device Identifier: 00813502012811
• UDI-Public: (01)00813502012811(17)270131(10)2026671837
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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: 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 Catalogue Number: 1000323
• Device Lot Number: 2026671837
• 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: 08/31/2026
• Initial Report FDA Received Date: 09/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/21/2025
• 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: Death; Required Intervention
• Patient Age: 71 YR
• Patient Sex: Female
• Patient Weight: 158 LB
• Patient Race: White