MAUDE Adverse Event Report: Abiomed, Inc. - 1220648 Impella; Introducer, Catheter (Introducer)

Catalog Number	0052-3046
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Ischemia (1942)
Date of Event	07/26/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Impella cp was inserted via the right femoral artery in a 56-year-old male patient for acute myocardial infarction complicated by cardiogenic shock.The patient's comorbidities included coronary artery disease.The patient's clinical state prior to initiation of support was society for cardiovascular angiography and interventions (scai) shock stage e (extremis), indicating hypoperfusion and organ failure despite numerous interventions.Prior to impella support, the patient was reported to be receiving inotropes, vasopressors, and respiratory support.During support, while the 14f peel away was still indwelling, angiography demonstrated that the impella cp was partially occlusive.The 14 french peel-away sheath was removed outside of the body, and the repositioning sheath was advanced.Due to concerns regarding perfusion while the 14 french peel-away sheath was in place, a decision was made to place an antegrade sheath in the right superficial femoral artery and an arterial donor line from the left common femoral artery to create an external arterial bypass.Following the intervention, pulses were present in the right lower extremity on the impella access side with clear evidence of perfusion reported by the clinical staff.The impella cp was operating at p-level 7 with flows of 3.3 l/min.The purge solution contained 5% dextrose in water with sodium bicarbonate.The patient remained stable without reported harm following the intervention.The impella cp was subsequently removed after escalation of support to an impella 5.5 device.The post-procedure outcome was reported as stable without harm and survived to escalation and explant of the impella cp.Based on the available information, perfusion was restored following vascular intervention, with pulses present and no reported patient injury.Due to the limited information provided, the relationship between the reported partial occlusion was likely contributable to the large bore access of the 14 french introducer sheath.The partial occluded flow to the extremity resolved with intervention of the perfusion catheter and removal of the 14french peel away sheath, and the impella cp functioned as intended.
Additional Manufacturer Narrative
A5 and a6 are unknown.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: Introducer, Catheter (Introducer)
• 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 ; +1(781)493-4967
• MDR Report Key: 50174305
• Report Number: 1220648-2026-11365
• Device Sequence Number: 9886345
• Product Code: DYB
• UDI-Device Identifier: 00813502013474
• UDI-Public: (01)00813502013474(17)270930(10)S9299649
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: 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: 0052-3046
• Device Lot Number: S9299649
• 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: 07/26/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/07/2026
• Supplement Report FDA Received Date: 09/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/30/2024
• 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: 56 YR
• Patient Sex: Male
• Patient Weight: 171 LB