MAUDE Adverse Event Report: Abiomed, Inc. - 1220648 Impella; Temporary Non-Roller Type Left Heart Support Blood Pump

Catalog Number	1000080
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/23/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Demographics/indication/baseline presentation: an impella cp smartassist was inserted percutaneously via left femoral access site in 70-year-old, female patient height 152 cm, weight 86 kilograms for acute myocardial infarction/ cardiogenic shock.The patient¿s comorbidities were coronary artery disease and diabetes mellitus.The patient¿s clinical state prior to initiation of support was society for cardiovascular angiography intervention (scai) shock stage a identified as hemodynamically stable patient who is not experiencing signs or symptoms of cardiogenic shock but is a risk for its development.The patient was on inotropes, vasopressors and respiratory support.Device course & treatment: on the day of implantation, the patient became restless and moved extensively in bed without knee immobilization in place.The impella cpsa became entangled in the patient's feet and was inadvertently pulled back into the descending aorta.The physician on call was notified and, due to the patient's stable hemodynamic status, advised delaying intervention until the following morning.Upon evaluation, the anti-contamination sleeve was noted to have been pulled loose from the repositioning sheath; however, the touhy-borst connector remained tightened and the repositioning sheath remained sutured to the leg.The patient was transferred to the cardiac catheterization laboratory for attempted re-advancement or replacement of the device.The initial impella cp was removed the next day and replaced with a second impella cp via the same left femoral arterial access.The patient survived the event.Additional factors: patient movement while no leg immobilization was in place.Device contribution: the event was associated with patient movement and loss of device position rather than a device malfunction.However, since device was replaced the device and event can not be conclusively dissociated.
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: 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): Danvers
• Manufacturer Contact: derek sammarco ; 22 cherry hill dr.; danvers, MA 01923 ; +1(781)493-4967
• MDR Report Key: 50922824
• Report Number: 1220648-2026-13439
• Device Sequence Number: 5803948
• Product Code: OZD
• UDI-Device Identifier: 00813502012279
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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: Other Health Care Professional
• 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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 1000080
• Device Lot Number: 2027941638
• 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: 09/23/2026
• Initial Report FDA Received Date: 09/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/28/2026
• 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: 70 YR
• Patient Sex: Female
• Patient Weight: 189 LB
• Patient Race: White