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 Code	Hematuria (2558)
Date of Event	09/24/2026
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 53-year-old male patient (weight 89 kilograms) for acute myocardial infarction/ cardiogenic shock.The patient¿s comorbidities were coronary artery disease (cad).The patient¿s clinical state prior to initiation of support was society for cardiovascular angiography intervention (scai) shock stage c identified as clinical evidence of hypoperfusion that initially requires pharmacological or mechanical support.The patient was on inotropes, vasopressors and respiratory support.Device course & treatment: on day 2 of support, the patient developed pink-tinged urine, which was reported as hematuria.Imaging confirmed appropriate pump position and no anatomical abnormalities of the heart were reported.The pump was repositioned in response to the event, after which the pink-tinged urine resolved.There was no reported infusion of blood products, no reported contact of the pump with the mitral apparatus, and no reported organ damage.On day 3 of support, the device was explanted following successful weaning.The patient survived to explant and was reported to be stable.Additional factors: central venous pressure (cvp) of 14 mmhg (normal range 2 to 8 mmhg).Elevated central venous pressures (cvp) suggest impaired forward flow and inadequate preload transfer to the left ventricle.These conditions may increase red blood cell shear stress and contribute to hemolysis.Device contribution: a report of hematuria, manifested by pink-tinged urine, occurred during impella cp support.Following pump repositioning, the reported hematuria resolved.The patient was successfully weaned from support, survived to explant, and remained stable.The relationship between hematuria and the device cannot be excluded.
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: 50946618
• Report Number: 1220648-2026-13495
• Device Sequence Number: 18753606
• Product Code: OZD
• UDI-Device Identifier: 00813502012279
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 09/30/2026

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 1000080
• Device Lot Number: 2027949726
• 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: 09/24/2026
• Initial Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/07/2026
• 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: 53 YR
• Patient Sex: Male
• Patient Weight: 195 LB
• Patient Race: Black Or African American