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

Catalog Number	0048-3092-JP
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Cardiac Perforation (2513)
Date of Event	08/13/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
An impella cp was inserted via femoral artery access of unspecified side in an 80-year-old female patient presenting with post-cardiotomy cardiogenic shock and low cardiac output syndrome following mitral valve repair.The patient's medical history was significant for mitral valve regurgitation.The society for cardiovascular angiography and interventions (scai) shock stage prior to initiation of support was not reported.The impella cp was implanted after the patient failed to wean from cardiopulmonary bypass in the operating room.Device placement was performed using transesophageal echocardiography (tee) and fluoroscopic guidance.Visualization of the left ventricular apex was reported to be limited due to the presence of mitral valve surgical devices, necessitating repeated echocardiographic assessments to guide device positioning.During positioning of the impella cp, a left ventricular perforation was observed.The perforation was surgically repaired, and the impella cp was subsequently explanted.Extracorporeal membrane oxygenation (ecmo) was then initiated to provide ongoing hemodynamic support.The duration of impella support was approximately two hours.No pump performance metrics, hemodynamic parameters, or laboratory values were reported during support.The patient survived the ventricular perforation and surgical repair.No additional patient outcome information was provided.Due to limited information on device depth during the surgery the device cannot be dissociated from the event.It is important to note that ventricular size and wall integrity should be taken into account when placing an impella device in a patient per optimal device performance (odp) odp-010 guidance on impella device implantation in small anatomies.It is important to note the decrease in ventricular cavity when a patient is on cardiopulmonary bypass and the heart is empty.
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.

• 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 Contact: derek sammarco ; 22 cherry hill drive; danvers, MA 01923 ; +1(781)493-4967
• MDR Report Key: 50451270
• Report Number: 1220648-2026-12063
• Device Sequence Number: 9780839
• Product Code: OZD
• UDI-Device Identifier: 00813502011371
• UDI-Public: (01)00813502011371(17)280131(10)2027927027
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/26/2026

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: 0048-3092-JP
• Device Lot Number: 2027927027
• 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: 08/18/2026
• Initial Report FDA Received Date: 08/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/30/2026
• 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: 80 YR
• Patient Sex: Female
• Patient Weight: 101 LB
• Patient Race: Asian