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

Catalog Number	0048-0024-JP
Medical Device Problem Codes	Malposition of Device (2616); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Hemolysis (1886)
Date of Event	07/25/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Us updated clinical narrative: additional information provided on 31jul2026 the device was explanted on (b)(6)2026 prior us clinical narrative: impella cp was percutaneously inserted via left femoral artery access site in a 77-year-old male patient presenting with cardiomyopathy and suspected myocarditis.The patient¿s comorbidities were not reported.The patient¿s clinical state prior to initiation of support was society for cardiovascular angiography and interventions (scai) shock stage d.The patient was medically supported by inotropes, vasopressors and was concurrently on ecmo.During impella support, there were concerns of hemolysis identified by hematuria.Imaging was utilized to assess pump position, and improper device positioning was initially suspected; however, despite position adjustment, hemolysis persisted without immediate improvement.No anatomical cardiac abnormalities were reported, and there was no reported contact between the pump and mitral valve structures.Haptoglobin therapy was administered, and following ecmo weaning and reduction of impella support level from performance (p) level p-7 to p-4, the hemolysis showed signs of improvement.The hemolysis was most likely contributed to the patient being on multiple mechanical circulatory support devices which can have an increase on shear stress of the red blood cells due resulting in hemolysis.
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 (Section G): Danvers
• Manufacturer Contact: derek sammarco ; 22 cherry hill drive; danvers, MA 01923 ; +1(781)493-4967
• MDR Report Key: 50114548
• Report Number: 1220648-2026-11177
• Device Sequence Number: 5305067
• Product Code: OZD
• UDI-Device Identifier: 00813502011609
• UDI-Public: (01)00813502011609(17)271231(10)2027858007
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• 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: 0048-0024-JP
• Device Lot Number: 2027858007
• 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: 07/26/2026
• Initial Report FDA Received Date: 08/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/09/2026
• 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: 77 YR
• Patient Sex: Male
• Patient Race: Asian