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

Catalog Number	0052-3046
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	09/17/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
An impella cp with smartassist was inserted via the right femoral artery in an 81 year-old male patient presenting with acute myocardial infarction complicated by cardiogenic shock (ami/cgs).The patient's clinical state prior to initiation of support was society for cardiovascular angiography and interventions (scai) shock stage d.Scai stage d is defined as evidence of shock that worsens or fails to improve despite escalation therapies.Prior to impella support, the patient was receiving vasopressor, inotropic, and respiratory support.Medical history was significant for cardiac arrest requiring extracorporeal cardiopulmonary resuscitation (ecpr).Height was not reported, and the patient weighed 98 kg.During implantation, the impella cp was initially inserted via the right femoral artery.Following placement of the repositioning sheath, a large hematoma developed at the access site.The physician elected to remove the impella device and place a 14 french x 25 cm sheath, after which the impella was reinserted and restarted.Due to ongoing bleeding, angiography was performed and a vascular surgeon was consulted.The surgeon accessed the vasculature from the left femoral artery access site to tamponade the right groin bleeding.Attempts to close the right femoral access site using perclose devices were unsuccessful.Manual pressure was then maintained while the vascular surgeon worked to achieve hemostasis.Upon resolution of the bleeding, a 14 french x 13 cm sheath was advanced via the left femoral artery and the impella cp was successfully reinserted.It is not recommended by abiomed to reinsert a device once it had entered the patient's body on the following day of support, hemolysis was reported, evidenced by merlot-colored urine.No laboratory values were reported to confirm the reported hemolysis.Imaging was performed to assess device position and demonstrated contact between the pump and the mitral apparatus.It was reported as being unknown if repositioning corrected the hemolysis.Despite ongoing support, the patient's condition deteriorated, progressing to society for cardiovascular angiography and interventions (scai) shock stage e.Scai stage e is defined as refractory shock or actual/impending circulatory collapse in which the body fails to respond to maximal lifesaving therapies, leading to full organ shutdown.Lactate increased from 4.9 mmol/l prior to support to 13 mmol/l, and the patient continued to require vasoactive medications.After approximately 25 hours of support, the family elected to withdraw care and the patient subsequently expired.The explant was not reported to be related to the hemolysis.Throughout support, the impella cp functioned as intended at performance level 7 providing expected flows of 2.9 liters per minute.The reported access-site hematoma and subsequent hemolysis can be associated with impella cp support.The hematoma occurred during implantation and required vascular intervention, removal of the initial device, and reimplantation through the contralateral femoral artery.Hemolysis was subsequently reported during support with merlot-colored urine and imaging demonstrating contact between the pump and the mitral apparatus.The impella cp functioned as intended throughout support and there is no indication that the hemolysis or the hematoma contributed to the patient's outcome of death, therefor the device is dissociated from the patient outcome.
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.

• Brand Name: Impella
• Common Device Name: Introducer, Catheter (Introducer)
• Manufacturer (Section D): Abiomed, Inc. - 1220648; 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: 50914291
• Report Number: 1220648-2026-13399
• Device Sequence Number: 5394547
• Product Code: DYB
• UDI-Device Identifier: 00813502013474
• UDI-Public: (01)00813502013474(17)280630(10)S9998673
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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

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: S9998673
• 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: 09/17/2026
• Initial Report FDA Received Date: 09/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/24/2025
• 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: 81 YR
• Patient Sex: Male
• Patient Weight: 215 LB
• Patient Race: White