MAUDE Adverse Event Report: ABIOMED, INC. - 1220648 KIT, 14FR INTRODUCER, 13CM&25CM, STERILE; INTRODUCER, CATHETER (SHEATH)

Catalog Number	0052-3046
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Ischemia (1942)
Date of Event	06/01/2026
Type of Reportable Event	Death
Event or Problem Description
An impella cp device was inserted via the right femoral artery in an 84-year-old male patient presenting with acute myocardial infarction complicated by cardiogenic shock.The patient¿s medical history was notable for peripheral arterial disease and peripheral vascular disease.The patient¿s clinical state prior to initiation of support was society for cardiovascular angiography and interventions (scai) shock stage c.Access was obtained using micropuncture technique with ultrasound and femoral angiography guidance.Due to significant peripheral arterial disease, shockwave lithotripsy was utilized on the iliac artery and aorta.A 25 centimeter impella sheath was placed without difficulty, and the impella cp device was successfully inserted.Following percutaneous coronary intervention, the peel-away sheath was removed and a repositioning sheath was advanced.Femoral angiography demonstrated absence of distal flow beyond the impella sheath.A 6 french right femoral antegrade sheath and a 6 french left femoral retrograde sheath were placed, and the side ports were connected to establish flow to the right lower extremity.Angiography confirmed restoration of flow to both lower extremities.Weak doppler signals were noted in bilateral lower extremities upon arrival to the intensive care unit.During support, the impella cp device was operating at performance level 7 with lower than expected flows of 2.5 liters per minute.The mean arterial pressure was reported at 111 millimeters of mercury, and the patient remained on inotropes and vasopressors for hemodynamic support.The purge solution consisted of dextrose 5% in water with 25 milliequivalents per liter of sodium bicarbonate.A decision was made to withdraw care, and the patient subsequently expired.The death is conservatively being reported; however, it is most likely attributed to the patient¿s underlying critical clinical condition due to acute myocardial infarction complicated by cardiogenic shock as the patient presented in society for cardiovascular angiography and interventions (scai) shock stage c.
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
Peripheral arterial ischemia/pdi: the cause of the injury was not determined due to insufficient clinical details.

• Brand Name: KIT, 14FR INTRODUCER, 13CM&25CM, STERILE
• Common Device Name: INTRODUCER, CATHETER (SHEATH)
• 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 dr.; danvers, MA 01923 ; 7814934967
• MDR Report Key: 25445320
• Report Number: 1220648-2026-08636
• Device Sequence Number: 13150794
• Product Code: DYB
• UDI-Device Identifier: 00813502011678
• UDI-Public: (01)00813502011678(10)S9834193(17)280531(11)250613
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• 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
• Report Date (Section B): 06/09/2026

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: 0052-3046
• Device Lot Number: S9834193
• 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: 06/01/2026
• Supplement Date Received by Manufacturer: 07/16/2026
• Initial Report FDA Received Date: 06/09/2026
• Supplement Report FDA Received Date: 07/17/2026
• 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: Death; Required Intervention
• Patient Age: 84 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White