MAUDE Adverse Event Report: ABIOMED, INC. - 1220648 AXILLARY INSERTION- GRAFT LOCK; INTRODUCER, CATHETER

Catalog Number	0052-0500
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	10/17/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
An impella 5.5 device was inserted surgically into the right axillary/subclavian artery in a 58-year-old female patient presenting in heart failure/cardiogenic shock, cardiomyopathy, in scai stage c shock, on multiple inotropes and vasopressors, prior to initiation of support.During the procedure, there was blood leaking around the graft locks.While the patient was in the intensive care unit (icu), the patient had renal failure requiring dialysis.Two months after impella insertion, the device was removed with a bridge to a heart transplant.The post-procedure outcome is survived at explant.The impella functioned at p-6 at 3.3l/min as intended.Renal failure is a known adverse event associated with impella's mechanical support.
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
After further review the impacted product updated to graft lock from introducer d1 and d4 revised.

• Brand Name: AXILLARY INSERTION- GRAFT LOCK
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): ABIOMED, INC. - 1220648; 22 cherry hill drive; danvers MA 01923
• Manufacturer (Section G): ABIOMED, INC.; 22 cherry hill drive; danvers MA 01923
• Manufacturer Contact: derek sammarco ; 22 cherry hill drive; danvers, MA 01923 ; 7814934967
• MDR Report Key: 24658301
• Report Number: 1220648-2026-05753
• Device Sequence Number: 9289818
• Product Code: DYB
• UDI-Device Identifier: 00885672009755
• UDI-Public: (01)00885672009755(17)280131(10)S9408541
• 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: 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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 0052-0500
• Device Lot Number: S9408541
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/17/2025
• Supplement Date Received by Manufacturer: 07/13/2026
• Initial Report FDA Received Date: 03/22/2026
• Supplement Report FDA Received Date: 07/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/27/2025
• 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: 58 YR
• Patient Sex: Female
• Patient Weight: 81 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian