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 Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fever (1858); Unspecified Infection (1930)
Date of Event	05/22/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A4 is unknown.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
A 12 year old female patient with a history of cardiomyopathy and a pre support clinical status consistent with scai shock stage c was hospitalized on (b)(6) 2024 with circulatory failure secondary to acute myocarditis.On hospital day 9, the patient developed low grade fever (37°c).Multiple cultures were obtained and were unremarkable, and empiric antibiotic therapy did not result in clinical improvement.Va ecmo and transvenous pacing were discontinued on hospital day 10.While the patient¿s body temperature was initially controlled through chd circuit temperature management, discontinuation of chd on hospital day 14 was followed by a rapid temperature increase to 40°c, associated with worsening cardiac function.Antipyretic therapies, including acetaminophen and flurbiprofen axetil, were ineffective, and chd was resumed on hospital day 15 for temperature control.Following explant of the impella cp on (b)(6) 2024 at 5:04 am, the patient¿s fever pattern improved.Based on the available information, this complaint documents a febrile event occurring during impella cp support in a pediatric patient with acute myocarditis and multisystem critical illness.Extensive infectious workup did not reveal a definitive source, and the temporal improvement in fever following device explant was noted; however, the contribution of multiple confounding factors¿including underlying myocarditis, prior va ecmo, and chd¿precludes determination of a clear causal relationship between the impella device and the fever.No device failure or malfunction was identified, and patient outcome was survival with successful weaning.The relationship between the patient¿s fever and the impella device remains not clear.
Additional Manufacturer Narrative
Corrected information was provided in d3 (manufacturer fax).Upon review, it was identified that it was inadvertently omitted from the initial report.H6: updated codes based on the results of the investigation.H11: updated based on the results of the investigation.The root cause of the injury was unable to be determined due to insufficient clinical details.

• 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 ; 7814934967
• MDR Report Key: 24764859
• Report Number: 1220648-2026-06287
• Device Sequence Number: 9267488
• Product Code: OZD
• UDI-Device Identifier: 00813502011609
• UDI-Public: (01)00813502011609(17)250531(10)2024350516
• 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: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup

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: 05/31/2025
• Device Catalogue Number: 0048-0024-JP
• Device Lot Number: 2024350516
• 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: 03/25/2026
• Supplement Date Received by Manufacturer: 04/24/2026
• Initial Report FDA Received Date: 04/02/2026
• Supplement Report FDA Received Date: 04/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/15/2023
• 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: 12 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian