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

Catalog Number	1000323
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Codes	Bradycardia (1751); Cardiac Arrest (1762); Low Blood Pressure/ Hypotension (1914); Pericardial Effusion (3271)
Date of Event	09/14/2026
Type of Reportable Event	Death
Event or Problem Description
An impella rp flex with smartassist was attempted via the right internal jugular vein in a 66 year-old female patient presenting post-cardiac arrest with right ventricular failure secondary to pulmonary embolism.The society for cardiovascular angiography and interventions (scai) shock stage was not reported.No significant past medical history was reported.The patient underwent thrombectomy for pulmonary embolism.A left heart catheterization was performed via radial access, and the left anterior descending (lad) artery was stented.A right heart catheterization was then performed, and a decision was made to implant an impella rp flex device for right ventricular support.A swan-ganz catheter was advanced without difficulty, and a guidewire was successfully positioned within the right pulmonary artery.After removal of the swan-ganz catheter, the impella rp flex was advanced over the guidewire.However, the device was unable to track across the pulmonary valve.Multiple attempts were made to advance the device beyond the valve.During troubleshooting, the physician removed slack from the guidewire and attempted advancement again.Subsequently, the guidewire dropped below the pulmonary valve, and the decision was made to remove the impella rp flex and re-establish access over a swan-ganz catheter.Shortly after removal of the impella rp flex, the patient developed sinus bradycardia accompanied by significant drop in blood pressure.A code was initiated, and emergent echocardiographic imaging demonstrated a large pericardial effusion.Pericardiocentesis was subsequently performed.Despite resuscitative efforts, the patient expired in the catheterization laboratory procedure area.No pump performance metrics or purge solution information were available, as support was never successfully established with the impella rp flex.The patient's outcome of death cannot be dissociated from the reported event, as the patient became hemodynamically unstable shortly after device removal, developed a large pericardial effusion from the insertion attempt requiring pericardiocentesis, and subsequently experienced cardiac arrest and expired despite resuscitative efforts.
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 dr.; danvers, MA 01923 ; +1(781)493-4967
• MDR Report Key: 50845898
• Report Number: 1220648-2026-13140
• Device Sequence Number: 16018101
• Product Code: PYX
• UDI-Device Identifier: 00813502012811
• UDI-Public: (01)00813502012811(17)270531(10)2026719736
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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
• Report Date (Section B): 09/21/2026

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: 2026719736
• 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: 09/14/2026
• Initial Report FDA Received Date: 09/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/15/2025
• 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: 66 YR
• Patient Sex: Female
• Patient Weight: 169 LB
• Patient Race: White