MAUDE Adverse Event Report: ABIOMED, INC. IMPELLA; TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP

Model Number	IMPELLA CP SMART ASSIST SET, JP
Medical Device Problem Codes	Restricted Flow rate (1248); Malposition of Device (2616)
Health Effect - Clinical Code	Low Blood Pressure/ Hypotension (1914)
Date of Event	01/28/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
E4 and g2 (study) was inadvertently omitted on the initial manufacturer device report.
Additional Manufacturer Narrative
The impella device has not been received from the customer.Therefore, investigation of the device is not possible.Should the device or any new information be received, a supplemental mdr will be filed.
Event or Problem Description
A case study reported that an impella cp was inserted into the right femoral artery of a 58-year-old male who presented with exertional fatigue two weeks earlier and was diagnosed with ischemic cardiomyopathy associated with three-vessel disease.He had persistent low cardiac function (left ventricular ejection fraction 12%) and ventricular tachycardia, and was referred to our hospital for revascularization.The impella was inserted for ventricular support for an off-pump coronary artery bypass graft (opcab).During the surgery, he experienced episodes of hypotension.Transesophageal echocardiogram (tee) revealed that the impella inlet was located at the left ventricular apex, and the outlet was visualized entering and exiting the left ventricular cavity just above the aortic valve, suggesting a poorly positioned impella.Frequent positioning adjustments were required to maintain flow.Because the impella was already fixed to the thigh, adjusting its position was difficult, and circulatory management was necessary without relying on the impella.After anastomosis of the left circumflex artery and release of the device from rotation, hemodynamics remained stable, and the procedure was completed.The post-procedure outcome was survived at explant.Correct positioning of the impella cp is directly related to hemodynamics; improper placement commonly causes hypotension, low flow, or suction alarms.When the device moves too far into the left ventricle or too far out into the aorta, it cannot effectively move blood, leading to ineffective support and low blood pressure.
Additional Manufacturer Narrative
Corrected information was provided in b1 (is product problem).Upon review, it was identified that it was inadvertently omitted from the initial report.Corrected information was provided in d1 (brand name).Upon review, it was identified that the section d brand name has now been updated.H6: updated codes based on the results of the investigation.H11: updated based on the results of the investigation.The cause of the injury could not be determined due to insufficient clinical details.The cause of the low or blocked pump flow issue could not be determined without the returned product for investigation and sufficient clinical details, including data logs.The cause of the positioning issue could not be determined without the returned product for investigation and sufficient clinical details.

• Brand Name: IMPELLA
• Common Device Name: TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP
• Manufacturer (Section D): ABIOMED, INC.; 22 cherry hill drive; danvers MA 01923
• Manufacturer Contact: derek sammarco ; 22 cherry hill drive; danvers, MA 01923 ; 7814934967
• MDR Report Key: 24273339
• Report Number: 1220648-2026-02395
• Device Sequence Number: 10722758
• Product Code: OZD
• UDI-Device Identifier: 00813502011609
• UDI-Public: (01)00813502011609(10)2025575156(17)260831
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P140003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/05/2026

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 Expiration Date: 08/31/2026
• Device Model Number: IMPELLA CP SMART ASSIST SET, JP
• Device Catalogue Number: 0048-0024-JP
• Device Lot Number: 2025575156
• 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: 01/28/2026
• Supplement Date Received by Manufacturer: 02/01/2026; 03/31/2026
• Initial Report FDA Received Date: 02/05/2026
• Supplement Report FDA Received Date: 02/17/2026; 04/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/10/2024
• 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 Sex: Unknown
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian