MAUDE Adverse Event Report: ABIOMED, INC. - 1220648 IMPELLA; TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP

Catalog Number	0048-0024-JP
Medical Device Problem Codes	Use of Device Problem (1670); Malposition of Device (2616)
Health Effect - Clinical Code	Hemodynamic instability (4868)
Date of Event	03/29/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A3a.Sex/a3b.Gender is unknown.A4.Weight of the patient 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.
Event or Problem Description
Clinical narrative: an impella cp device was inserted via the femoral artery in a 75-year-old patient presenting with acute myocardial infarction complicated by cardiogenic shock (ami/cgs), scai shock stage e.The patient¿s comorbidities were unknown.After impella cp insertion, an alarm indicating that the pump position was within the aorta occurred while the patient was being repositioned in bed for transport back to the room.Fluoroscopic imaging confirmed that the device had been pulled into the aorta.A dryseal sheath was in use, and the valve was confirmed to be closed.The fixation wings were checked for tension.It was believed that a loose fixing ring, due to insufficient verification of securement, allowed tension to be transmitted during movement, resulting in device migration.The patient was subsequently managed with ecmo and an intra-aortic balloon pump (iabp), and the impella¿cp device was removed.The reported events are device in the wrong position, use against labeling, medical device removal, and hemodynamic instability.The device will be conservatively reported for serious injury due to temporary hemodynamic support interruption during device removal; however, the removal was performed with no consequence to the patient.
Additional Manufacturer Narrative
During the investigation process it was determined that h6 code a23 should not have been reported and therefore should be removed.B5 was also updated to align.The investigation is still underway once completed a supplemental report will be sent.
Event or Problem Description
Clinical narrative an impella cp device was inserted via the femoral artery in a 75-year-old patient presenting with acute myocardial infarction complicated by cardiogenic shock (ami/cgs), scai shock stage e.The patient¿s comorbidities were unknown.After impella cp insertion, an alarm indicating that the pump position was within the aorta occurred while the patient was being repositioned in bed for transport back to the room.Fluoroscopic imaging confirmed that the device had been pulled into the aorta.A dryseal sheath was in use, and the valve was confirmed to be closed.The fixation wings were checked for tension.It was believed that a loose fixing ring, due to insufficient verification of securement, allowed tension to be transmitted during movement, resulting in device migration.It was noted that the blue butterfly was accidentally not tightened all the way down, causing a positioning issue.The patient was subsequently managed with ecmo and an intra-aortic balloon pump (iabp), and the impella cp device was removed.The device will be conservatively reported for serious injury due to temporary hemodynamic support interruption during device removal; however, the removal was performed with no consequence to the patient, and support was managed with ecmo and an intra-aortic balloon pump (iabp) without any known adverse events.The patient survived to explant.
Additional Manufacturer Narrative
D4: serial.H6: investigation: type, findings, conclusion codes and h6 component codes were updated accordingly based on the completed investigation.The device was not returned; therefore, an evaluation/analysis of the device was not possible.Hemodynamic instability: the cause of the injury was not determined due to insufficient clinical details.Device in wrong position: the cause of position issue was most likely use related due to patient movement to return to his room and loose fixing ring due to insufficient checking.

• 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 ; 7814934967
• MDR Report Key: 24780719
• Report Number: 1220648-2026-06359
• Device Sequence Number: 18651207
• Product Code: OZD
• UDI-Device Identifier: 00813502011609
• UDI-Public: (01)00813502011609(17)270630(10)2026735848
• 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: 2026
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup

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: 0048-0024-JP
• Device Lot Number: 2026735848
• 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: 03/30/2026
• Supplement Date Received by Manufacturer: 04/21/2026; 06/17/2026
• Initial Report FDA Received Date: 04/03/2026
• Supplement Report FDA Received Date: 04/22/2026; 06/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/13/2025
• 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: Other
• Patient Age: 75 YR
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian