MAUDE Adverse Event Report: ABIOMED, INC. - 1220648 IMPELLA; TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP

Catalog Number	0052-3046
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hematoma (1884); Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	04/15/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
An impella cp device was inserted percutaneously via the right femoral artery in a 66-year-old male patient for high-risk percutaneous coronary intervention (hrpci) in the setting of society for cardiovascular angiography and interventions (scai) stage d cardiogenic shock.While the peel-away sheath remained in place, a hematoma developed at the right femoral access site.Following removal of the peel-away sheath and advancement of a repositioning sheath, persistent oozing was noted, and the hematoma continued to enlarge.Due to progressive access-site bleeding, dr.Harrison elected to remove the impella cp device.A 14-french gore dryseal sheath was placed, and an intra-aortic balloon pump (iabp) was inserted to support the patient¿s hemodynamic needs.The reported access-site bleeding and hematoma are consistent with known complications associated with large-bore femoral arterial access and the anticoagulation requirements of impella support, and may be influenced by patient-specific and procedural factors.
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.
Additional Manufacturer Narrative
Hematoma/major bleed/access site adverse event: the cause of the bleed at the access site was unbale to be determined due to limited 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: 24939350
• Report Number: 1220648-2026-07001
• Device Sequence Number: 13424961
• Product Code: OZD
• UDI-Device Identifier: 00813502011678
• UDI-Public: (01)00813502011678(11)250613(10)S9834192
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: P140003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: 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: 0052-3046
• Device Lot Number: S9834192
• 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: 04/15/2026
• Supplement Date Received by Manufacturer: 05/21/2026
• Initial Report FDA Received Date: 04/21/2026
• Supplement Report FDA Received Date: 05/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/13/2025
• 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: 66 YR
• Patient Sex: Male
• Patient Weight: 163 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White