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

Catalog Number	0052-0002-EU
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Perforation of Vessels (2135); Hypovolemia (2243)
Date of Event	09/11/2026
Type of Reportable Event	Death
Event or Problem Description
An impella rp was inserted percutaneously via the right femoral vein in a 72-year-old female patient with coronary artery disease.The patient was classified as scai shock stage a prior to support initiation, indicating a hemodynamically stable patient at risk for developing cardiogenic shock.During the procedure, the impella rp became dislodged and migrated into the right ventricle during removal of the peel-away sheath.The device was subsequently removed due to the event.During an attempt to insert a new sheath, perforation of the femoral vein occurred, resulting in significant vascular injury and bleeding from the groin/femoral vein.The patient required vascular repair and transfusion of six units of red blood cells; however, bleeding could not be controlled.The patient subsequently developed hemorrhagic/hypovolemic shock and expired on the same day as implant and explant.Due to the significant blood loss from the venous perforation during the sheath reinsertion the device is considered to have contributed to the patient outcome of death.Additional information received on 16sep2026 indicated: the reason for inserting the second sheath was, to limit the bleeding of the vein and save access which is not a recommended use, the patient was on full anticoagulation (a 23 fr ¿hole¿ in the vein) and sheath was there for possible implant of a second rp if possible.The patient did not have a backup rp at that time.The transfer of a second rp from another hospital was organized in parallel.Therefore, an attempt was made to insert a non-jnj sheath (not one of our products).
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.

• Brand Name: Impella
• Common Device Name: Introducer, Catheter
• 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: 50913432
• Report Number: 1220648-2026-13351
• Device Sequence Number: 5393497
• Product Code: DYB
• UDI-Device Identifier: 00813502011319
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K201116
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/28/2026

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: 0052-0002-EU
• 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: 09/11/2026
• Initial Report FDA Received Date: 09/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 72 YR
• Patient Sex: Female
• Patient Weight: 187 LB