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

Catalog Number	1000080
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Hematuria (2558)
Date of Event	09/22/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Product/patient demographics/indication/baseline presentation: an impella cp smartassist was inserted percutaneously via right femoral access site in 47-year-old male patient (weight 106 kilograms and height 182 cm) for acute myocardial infarction/ cardiogenic shock.The patient¿s comorbidities were not reported.The patient¿s clinical state prior to initiation of support was society for cardiovascular angiography intervention (scai) shock stage b identified as clinical evidence of hemodynamic instability, including but not limited to, hypotension, tachycardia, or abnormal systemic hemodynamics without hypoperfusion.Device course & treatment: during impella support, the patient developed hematuria with laboratory findings consistent with hemolysis, including plasma free hemoglobin of 298 mg/dl and ldh of 2085 u/l.Urine was noted to be pink/red-tinged.Imaging assessment was performed and demonstrated that the pump was positioned too deep within the ventricle.The device was repositioned, after which both the hemolysis and hematuria resolved and the urine cleared.No anatomic abnormalities of the heart were reported, and the pump was not reported to be in contact with the mitral valve apparatus, papillary muscles, or chordae tendineae.The impella cp was explanted the next day and the patient survived.Additional factors: the pump was positioned too deep within the ventricle.Elevated ldh and plasm free hemoglobin contribute to increased red blood cell shear stress and hemolysis.Device contribution: based on the available information, the reported hemolysis and hematuria was most likely associated with the suboptimal impella position.Device malposition is a recognized contributor to increased shear stress on red blood cells and may have contributed to the hematuria and hemolyzed laboratory specimens observed during support.
Additional Manufacturer Narrative
Product complaint # (b)(4).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 Left 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: 50932960
• Report Number: 1220648-2026-13467
• Device Sequence Number: 9563652
• Product Code: OZD
• UDI-Device Identifier: 00813502012279
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P140003
• 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
• Report Date (Section B): 09/29/2026

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: 1000080
• Device Lot Number: 2027942710
• 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: 09/22/2026
• Initial Report FDA Received Date: 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/29/2026
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 47 YR
• Patient Sex: Male
• Patient Weight: 233 LB
• Patient Race: Black Or African American