MAUDE Adverse Event Report: ABIOMED, INC. IMPELLA; TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP

Catalog Number	0048-0045
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Hemolysis (1886)
Date of Event	11/01/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Clinical narrative: an impella cp was inserted to support the 83 year old female cardiac patient, with medical history not shared.The pump was explanted a day after the support was placed due to concerns of hemolysis.The patient's plasma free hemoglobin level had risen from 1.7mg/dl to 95.3mg/dl.The patient had the pump explanted and replaced by an intra-aortic balloon pump.The patient survived the hemolysis.Hemolysis may be influenced by patient-specific factors such as critical illness, underlying cardiac dysfunction, hemodynamic instability, renal function, anticoagulation status, and potential device position.
Additional Manufacturer Narrative
The impella device has not been received from the customer.Therefore, investigation of the device is not possible.Should the device or any new information be received, a supplemental mdr will be filed.
Additional Manufacturer Narrative
The investigation for patient device interaction (hemolysis) has been completed.The root cause of the hemolysis was not determined due to lack of sufficient clinical details, inconclusive evidence from data log analysis, and unreturned product for further investigation.

• Brand Name: IMPELLA
• Common Device Name: TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP
• Manufacturer (Section D): ABIOMED, INC.; 22 cherry hill drive; danvers MA 01923
• Manufacturer Contact: derek sammarco ; 22 cherry hill drive; danvers, MA 01923 ; 7814934967
• MDR Report Key: 25045790
• Report Number: 1220648-2026-07290
• Device Sequence Number: 15847945
• Product Code: OZD
• UDI-Device Identifier: 00813502011876
• UDI-Public: (01)00813502011876(17)260630(10)2025563931
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P140003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/04/2026

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 Expiration Date: 06/30/2026
• Device Catalogue Number: 0048-0045
• Device Lot Number: 2025563931
• 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: 11/01/2024
• Supplement Date Received by Manufacturer: 05/01/2026
• Initial Report FDA Received Date: 04/30/2026
• Supplement Report FDA Received Date: 05/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/16/2024
• 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: 83 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian