MAUDE Adverse Event Report: ABIOMED, INC. - 1220648 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 Codes	Arrhythmia (1721); Ischemia (1942); Renal Failure (2041); Tachycardia (2095); Respiratory Failure (2484); Thromboembolism (2654)
Date of Event	11/09/2024
Type of Reportable Event	Death
Additional Manufacturer Narrative
H6: updated codes based on the results of the investigation.H11: updated based on the results of the investigation and added clinical review.Corrected information has been provided in d10(concomitant med products) the root cause of the injury was not determined due to insufficient clinical details.
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.
Event or Problem Description
An impella device was inserted in a 53-year-old male with a past medical history of coronary artery disease (cad) and renal insufficiency.The impella was inserted for ventricular support during a protected percutaneous coronary intervention (pci) on (b)(6) 2024.After the impella was inserted, the patient experienced atrial flutter and was cardioverted to sinus tachycardia.The patient was placed on intravenous (iv) amiodarone for preventative care until on (b)(6) 2024, when he was cleared and put on oral amiodarone for prophylaxis.Atrial flutter was determined to have a probable relationship to the impella device.The event is considered recovered with no sequelae.On (b)(6) 2024, the intra-aortic balloon pump (iabp) was removed.The patient had a cold right lower extremity on exam on (b)(6) 2024.There were slightly improved doppler pulses on (b)(6) 2024 but on (b)(6) 2024, an angiogram showed blood clot in the superficial femoral artery.Aspirin and plavix were given.A thrombectomy was scheduled, but the patient expired before the procedure could be performed.Right lower extremity ischemia was determined to have a probable relationship to the impella device.The event is considered not recovered/not resolved.On (b)(6) 2024, the patient showed signs of worsening kidney function, and was monitored by nephrology due to the patient's history of kidney disease.The patient was diagnosed with acute kidney injury (aki) and was placed on dialysis starting on (b)(6) 2024, which significantly improved his kidney function, but the patient expired before the aki was completely resolved.Acute kidney injury was determined to have a possible relationship to the impella device.The event is considered not recovered/not resolved.On (b)(6) 2024, the patient was noted to have worsening hypoxia and placed on a venti-mask.The patient was upgraded to the intensive care unit (icu) and placed on a high-flow nasal cannula, then was re-intubated on (b)(6) 2024 with worsening status.He remained intubated until the family withdrew care, and the patient expired on (b)(6) 2024.Worsening acute hypoxic respiratory failure was determined to have a probable relationship to the impella device.The event is considered not recovered/not resolved.

• 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 dr.; danvers, MA 01923 ; 7814934967
• MDR Report Key: 25380395
• Report Number: 1220648-2026-08445
• Device Sequence Number: 10568873
• Product Code: OZD
• UDI-Device Identifier: 00813502011876
• UDI-Public: (01)00813502011876(17)260731(10)2025559303
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 06/03/2026

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: 07/31/2026
• Device Catalogue Number: 0048-0045
• Device Lot Number: 2025559303
• 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: 05/28/2026
• Supplement Date Received by Manufacturer: 06/17/2026
• Initial Report FDA Received Date: 06/03/2026
• Supplement Report FDA Received Date: 06/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/06/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: INTRA-AORTIC BALLOON PUMP (IABP)
• Outcome Attributed to Adverse Event: Death
• Patient Age: 53 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American