MAUDE Adverse Event Report: ABIOMED, INC. AXILLARY INSERTION KIT; INTRODUCER, CATHETER

Catalog Number	0052-3009
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	02/26/2026
Type of Reportable Event	Death
Additional Manufacturer Narrative
The impella device has not been received from the customer.Therefore, investigation of the device is not possible.Should the device or any new information be received, a supplemental mdr will be filed.
Event or Problem Description
An impella 5.5 device was inserted via the right axillary artery in a 64 year-old male patient presenting with acute myocardial infarction complicated by cardiogenic shock (ami/cgs), scai shock stage d, with a history of known coronary artery disease (cad) and renal insufficiency.The patient underwent impella 5.5 placement in the operating room, and a jp drain was placed, which demonstrated ongoing drainage.The patient received 1 unit of packed red blood cells (prbcs).The anticoagulation level was found to be high, prompting the care team to stop heparin, after which the bleeding stopped.Heparin was later restarted at a lower dose.The patient remained on support.The reported major bleed requiring blood transfusion and hemostasis is consistent with access-site complications and the anticoagulation/purge requirements associated with impella support.The bleeding was resolved with standard intervention.
Additional Manufacturer Narrative
Updated information: b2 selected death and added date of death.H1 changed to death.H6 impact code added f02.
Additional Manufacturer Narrative
Explant date was provided therefore d6b was updated.
Additional Manufacturer Narrative
Major bleed/access site adverse event: the cause of major bleed/access site adverse event was most likely use related since the clinical team confirmed the bleeding was resolved after stopping heparin.

• Brand Name: AXILLARY INSERTION KIT
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): ABIOMED, INC.; 22 cherry hill drive; danvers MA 01923
• Manufacturer Contact: derek sammarco ; 22 cherry hill drive; danvers, MA 01923 ; 7814934967
• MDR Report Key: 24542076
• Report Number: 1220648-2026-04692
• Device Sequence Number: 20249387
• Product Code: DYB
• UDI-Device Identifier: 00813502010015
• UDI-Public: (01)00813502010015(11)251015(10)2019340
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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,Followup,Followup
• Report Date (Section B): 03/26/2026

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: 0052-3009
• Device Lot Number: 2019340
• 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: 02/27/2026
• Supplement Date Received by Manufacturer: 03/18/2026; 03/25/2026; 04/28/2026
• Initial Report FDA Received Date: 03/08/2026
• Supplement Report FDA Received Date: 03/24/2026; 03/30/2026; 04/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/15/2025
• 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; Death
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Weight: 65 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White