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

Catalog Number	1000100
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/20/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Clinical narrative: product/patient demographics/indication/baseline presentation: an impella 5.5 with smartassist was planned for insertion via a right-sided arterial approach in a 28-year-old male patient presenting with acute-on-chronic decompensated cardiomyopathy.Specific artery was not reported.The patient's society for cardiovascular angiography and interventions (scai) shock stage was not reported.The patient's medical history was significant for coronary artery disease (cad).Height and weight were not reported.Device course & treatment: during the implantation, the impella 5.5 was advanced through to the right innominate artery.Despite multiple attempts over approximately one hour, the device could not be delivered to the intended position.Imaging was utilized during the procedure to assess device advancement and positioning.Due to the inability to successfully deliver the device, the procedure was ultimately aborted.No adverse events were reported.Additional factors: the treating team reported significant curvature of the patient's anatomy in the region of the graft attachment, which was considered a contributing factor to the inability to advance and deliver the device.No pump performance data, purge parameters, alarms, or patient injuries were reported because support was never established.Device contribution: the reported delivery failure cannot be ruled out as associated with the challenging anatomy encountered during the procedure, including the curvature of the graft and vascular pathway.
Additional Manufacturer Narrative
A4 weight is 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: 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 drive; danvers, MA 01923 ; +1(781)493-4967
• MDR Report Key: 50930909
• Report Number: 1220648-2026-13450
• Device Sequence Number: 9525838
• Product Code: OZD
• UDI-Device Identifier: 00813502012828
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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

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: 1000100
• Device Lot Number: 2027930846
• 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: 09/20/2026
• Initial Report FDA Received Date: 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/08/2026
• 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: 28 YR
• Patient Sex: Male
• Patient Race: White