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

Catalog Number	1000080
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hemolysis (1886); Renal Failure (2041); Hematuria (2558)
Date of Event	09/21/2026
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 68-year-old male patient (weight 120 kilograms and height 185 cm) for acute myocardial infarction/ cardiogenic shock.The patient¿s comorbidities were prior cardiopulmonary resuscitation (cpr).The patient¿s clinical state prior to initiation of support was society for cardiovascular angiography intervention (scai) shock stage e identified as the body fails to respond to maximal lifesaving therapies.Device course & treatment: during impella support, the patient developed suspected hemolysis manifested by red/tinged urine.Hemolysis began while on support and was diagnosed based on urine discoloration; however, no laboratory values, including plasma free hemoglobin, were provided.Imaging and echocardiography confirmed appropriate pump position during the event, with no evidence of pump contact with the mitral apparatus and no reported suction events.The patient remained on p-9 support and was unable to be weaned.Additional clinical findings included renal failure requiring continuous renal replacement therapy (crrt), shock liver, cardiogenic shock, absent urine output, and elevated central venous pressure of 23 mmhg.Activated clotting time (act) and plasma free hemoglobin values were not reported.Elevated cvp may indicate impaired forward flow and inadequate preload transfer to the left ventricle, conditions that can contribute to increased red blood cell shear stress and hemolysis.The device was not removed due to the event.Additional factors: the patient was reported to be coagulopathic; however, associated coagulation laboratory values were not provided.Additional contributing clinical factors included advanced critical illness with scai shock stage e cardiogenic shock, ongoing vasopressor therapy, systemic anticoagulation, renal failure requiring crrt, shock liver and elevated cvp.The patient's severe underlying cardiac condition, vasopressor-dependent shock state, and reported coagulopathy may also have influenced thrombus formation, hemolysis, and the subsequent need for renal replacement therapy.Device contribution; the reported hemolysis is being associated with the impella cp.Although the device remained properly positioned, generated no alarms, and was reported to be functioning within expected operating parameters.However, the contribution of concomitant systemic anticoagulation, vasopressor therapy, severe cardiogenic shock, and the patient's underlying critical illness cannot be excluded as contributing factors to the reported hemolysis and renal failure.At the time of reporting, the patient remained alive.
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 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: 50932629
• Report Number: 1220648-2026-13468
• Device Sequence Number: 9525915
• Product Code: OZD
• UDI-Device Identifier: 00813502012279
• UDI-Public: (01)00813502012279(17)280531(10)2027938181
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,Followup

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 1000080
• Device Lot Number: 2027938181
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/21/2026
• Supplement Date Received by Manufacturer: 09/28/2026
• Initial Report FDA Received Date: 09/29/2026
• Supplement Report FDA Received Date: 10/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/21/2026
• 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
• Concomitant Medical Products and Therapy/Usage Dates: continuous renal replacement therapy (CRRT),
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Weight: 264 LB
• Patient Race: White