MAUDE Adverse Event Report: ABIOMED, INC. - 1220648 KIT, 23FR INTRODUCER, 11CM, STERILE; TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP

Catalog Number	2000342
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	11/25/2025
Type of Reportable Event	Death
Additional Manufacturer Narrative
Product complaint # (b)(4).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
On (b)(6) 2025, a 77-year-old woman was admitted with a type two aortic dissection.She underwent a bentall procedure with placement of a mechanical aortic valve and coronary artery bypass grafts to the left main coronary artery, which was dissected, as well as to the left circumflex coronary artery and the right coronary artery, which were also dissected.Following surgery, the patient was supported with an intra-aortic balloon pump due to difficulty separating from cardiopulmonary bypass and continued need for pharmacologic circulatory support.The patient experienced recurrent hypotension, and the decision was made to provide additional right ventricular support.During attempted device placement, the patient required defibrillation and direct cardiac massage by the surgeon on three occasions prior to successful pulmonary artery access and rp flex placement.During insertion of the sheath, a dissection of the iliac vein occurred.A surgical cutdown was performed, and the iliac vein injury was repaired successfully.On (b)(6) 2025, care was withdrawn.The event is being conservatively reported as a patient death; however, the outcome is believed to be related to the patient¿s underlying critical condition and the decision to withdraw life-sustaining therapy.

• Brand Name: KIT, 23FR INTRODUCER, 11CM, STERILE
• 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): ABIOMED, INC.; 22 cherry hill drive; danvers MA 01923
• Manufacturer Contact: derek sammarco ; 22 cherry hill drive; danvers, MA 01923 ; 7814934967
• MDR Report Key: 24640651
• Report Number: 1220648-2026-05654
• Device Sequence Number: 9876787
• Product Code: OZD
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• 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: 2000342
• Device Lot Number: S9653263
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/25/2025
• Supplement Date Received by Manufacturer: 09/22/2026
• Initial Report FDA Received Date: 03/19/2026
• Supplement Report FDA Received Date: 09/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/14/2025
• 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: Death; Required Intervention
• Patient Age: 79 YR
• Patient Sex: Female
• Patient Weight: 105 LB
• Patient Race: White