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 Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	07/15/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
An impella cp device was inserted into the right femoral artery in a 77-year-old male patient presenting in acute myocardial infarction (ami) and cardiogenic shock (cgs).The patient's clinical presentation was society for cardiovascular angiography & intervention (scai) stage d shock, on multiple inotropes and vasopressors, and on a ventilator for respiratory support, prior to initiation of support.The patient's comorbidities are unknown.On day one of support, upon arrival to the intensive care unit (icu), there was a hematoma noted in bilateral groins.Manual pressure was held, which resolved the issue.The patient received brilinta 180mg for the procedure.The activated clotting time (act) was 289.The patient was hemodynamically stable with a blood pressure of 109/56.On day 3 of support, there was reported gastrointestinal (gi) bleeding, which required the device to be removed.While on support, the impella functioned as intended at performance (p) level p-6 at 2.6l/min with d5w sodium bicarbonate in the purge solution.Bleeding can be attributed to the anticoagulant and antiplatelet therapy required for the treatment of acute myocardial infarction and cardiogenic shock, including the administration of brilinta and the elevated activated clotting time (act) of 289.The reported access-site hematomas further indicate an increased bleeding risk.No device malfunction was reported.The post-procedure outcome is survived at explant.
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
• 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 ; +1(781)493-4967
• MDR Report Key: 50074709
• Report Number: 1220648-2026-11022
• Device Sequence Number: 10219418
• Product Code: OZD
• UDI-Device Identifier: 00813502011876
• UDI-Public: (01)00813502011876(17)270731(10)2026761604
• 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: 2026
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/29/2026

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 Catalogue Number: 0048-0045
• Device Lot Number: 2026761604
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2026
• Supplement Date Received by Manufacturer: 09/11/2026
• Initial Report FDA Received Date: 07/29/2026
• Supplement Report FDA Received Date: 09/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/26/2025
• 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: Male
• Patient Weight: 169 LB
• Patient Race: Asian