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	Stroke/CVA (1770); Low Blood Pressure/ Hypotension (1914)
Date of Event	03/21/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A1, a4, and a6 are 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
An impella cp was inserted via the femoral artery to support a 77 year old female with a known cardiac history.She was known to be a heavy tobacco smoker, have hyperlipidemia, cardiogenic shock, and coronary artery disease.She was transferred to the tertiary medical center for care.She presented in scai stage d shock at admission.The cp was placed and allowed for the treatment of the acute myocardial infarction and cardiogenic shock.The pump provided support for the angioplasty and was explanted.Afterwards in the hospital stay she was found to have signs of a stroke/cva.There was arm weakness that prompted imaging and diagnosis made of an acute infarct with cerebral occlusion.The team performed thrombectomy and medically managed with vasopressin and levophed.She was followed by neurology and was noted to be stable.The harm post explant was thought to have a possible relationship to the use of the impella, but to date no imaging or other clinical details have been shared.The harm and intervention will be conservatively reported.
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.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: 25217132
• Report Number: 1220648-2026-08001
• Device Sequence Number: 21282379
• Product Code: OZD
• UDI-Device Identifier: 00813502011876
• UDI-Public: (01)00813502011876(17)261231(10)2026636321
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P140003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• 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

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 Catalogue Number: 0048-0045
• Device Lot Number: 2026636321
• 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: 05/12/2026
• Supplement Date Received by Manufacturer: 06/08/2026
• Initial Report FDA Received Date: 05/19/2026
• Supplement Report FDA Received Date: 06/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/13/2025
• 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: Female
• Patient Ethnicity: Hispanic