MAUDE Adverse Event Report: ABIOMED, INC. - 1220648 IMPELLA 2.5 AIC PUMP SET US; TEMPORARY NON-ROLLER TYPE CARDIAC SUPPORT BLOOD PUMP

Catalog Number	005042
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Codes	Arrhythmia (1721); Hemolysis (1886); Ischemia (1942); Pulmonary Edema (2020); Renal Failure (2041)
Date of Event	10/09/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A 37 yr-old female with history of cardiomyopathy, bi-v icd (biventricular implantable cardioverter-defibrillator), presented to emergency department in cgs.Coronary angiography performed revealing normal coronaries.Patient continued to decompensate and was placed on v-a ecmo the night before.Impella 2.5 was placed on (b)(6) 2021, via right femoral artery (rfa) for left ventricle unloading.Extra-corporeal fem-fem bypass placed due to small rfa and diminished flow down right leg.On (b)(6) 2021, patient has pulmonary edema and was scheduled to receive bronc treatment by pulmonary team that same day.On (b)(6) 2021, there were reports of hemolysis as plasma free hb was up from 30 to 260 on (b)(6): 315, (b)(6): 245.Additionally, an article published in 2025 related to this case indicated that ""the 2.5 was repositioned due to arrhythmia, and when there was hemolysis and renal failure, the 2.5 was explanted and replaced."" on (b)(6) 2021, impella migrated into lv (left ventricle) shortly after transport to (b)(6).Doctor pulled impella back to appropriate position using echo imaging.
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 2.5 AIC PUMP SET US
• Common Device Name: TEMPORARY NON-ROLLER TYPE CARDIAC 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 ; 7814934967
• MDR Report Key: 24524283
• Report Number: 1220648-2026-04572
• Device Sequence Number: 18268812
• Product Code: OZD
• UDI-Device Identifier: 00813502011081
• UDI-Public: (01)00813502011081(17)221231(10)2022044131
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: P140003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• 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

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 Expiration Date: 12/31/2022
• Device Catalogue Number: 005042
• Device Lot Number: 2022044131
• 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: 10/10/2025
• Initial Report FDA Received Date: 03/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/04/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 37 YR
• Patient Sex: Female
• Patient Race: Black Or African American