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

Catalog Number	0052-3005
Medical Device Problem Codes	Deformation Due to Compressive Stress (2889); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/16/2026
Type of Reportable Event	Death
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.
Event or Problem Description
Clinical rationale: an impella cp device was inserted in a 69-year-old male patient presenting in acute myocardial infarction (ami) and cardiogenic shock (cgs) prior to initiation of support.While in the cardiac catheterization lab (ccl), the patient expired.The physician mentioned a suspected material defect in the impella device.No further information regarding the case was provided.The post-procedure outcome was expired at explant.The device is unlikely to have contributed to the patient's death which was most likely due to the clinical condition of a critically ill patient with ami complicated by cgs.
Additional Manufacturer Narrative
Added b5 event description.
Event or Problem Description
Additional information has been provided: according to the physicians, there was no suspected causal relationship between the patient's death and the guidewire.The patient was described as hemodynamically highly unstable prior to the procedure and suffered from significant comorbidities.The impella cp device was successfully implanted, and the intended intervention could be performed.The physicians indicated that the clinical course and outcome were driven by the patient's critical baseline condition, rather than by the observed guidewire damage.At this stage, no indications were reported that the guidewire issue contributed to the patient¿s death.
Additional Manufacturer Narrative
Device information has been updated.The h6 (medical device problem code) has been revised.A04 is no longer applicable to this report.
Additional Manufacturer Narrative
Added b5 event description.
Event or Problem Description
Additional information has been provided: the death is conservatively being reported on the cp pump's guidewire due to the inability to conclusively dissociate the product from the patient outcome.An impella cp device was inserted in a 69-year-old male patient presenting with acute myocardial infarction complicated by cardiogenic shock.The society for cardiovascular angiography and interventions (scai) shock stage was not reported.While in the cardiac catheterization laboratory, the patient expired.The treating physician reported an issue involving the introducer wire, which appeared twisted or frayed.Per the treating physicians, the concern was limited to the introducer wire, and it was relayed that the impella cp pump itself was functioning properly.The post-procedure outcome was death at explant.The field representative responded that the reported issue involving the introducer wire was not considered to be the cause of death.Based on the available information, the death is unlikely to be device-related and is most likely attributable to the patient¿s underlying critical illness, including acute myocardial infarction complicated by cardiogenic shock and a highly complex clinical course.
Additional Manufacturer Narrative
Additional information/updated b5.H6 investigation: type, findings, and conclusion codes and h6 component codes were updated accordingly based on the completed investigation.
Event or Problem Description
Additional information has been provided upon request: the damage was identified during the implantation procedure.However, the impella could be advanced without any difficulties and was successfully positioned.Yes, both calcifications and vessel kinking were present.No, i do not have any additional information available at this time.
Additional Manufacturer Narrative
B5 updated.The investigation is ongoing.
Event or Problem Description
Additional information has been provided upon request: "1.Yes, according to the treating physicians, the issue was related to the introducer wire, which appeared to be twisted/frayed.The impella cp pump itself was functioning properly without any technical malfunction.2.The pump itself was not considered to be the cause of death.This was a highly complex clinical case involving multi-organ failure.".
Additional Manufacturer Narrative
Added: d3, g1.The cause of the guidewire damage was not determined due to insufficient clinical details and no product return.

• 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): ABIOMED, INC.; 22 cherry hill drive; danvers MA 01923
• Manufacturer Contact: derek sammarco ; 22 cherry hill drive; danvers, MA 01923 ; 7814934967
• MDR Report Key: 24456933
• Report Number: 1220648-2026-04125
• Device Sequence Number: 9969305
• Product Code: OZD
• UDI-Device Identifier: 04260113630303
• UDI-Public: (01)04260113630303(11)250203(10)8854091
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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,Followup,Followup
• Report Date (Section B): 03/05/2026

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 Catalogue Number: 0052-3005
• Device Lot Number: 8854091
• 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: 02/19/2026
• Supplement Date Received by Manufacturer: 02/26/2026; 04/27/2026; 05/20/2026; 05/29/2026; 06/08/2026; 06/16/2026
• Initial Report FDA Received Date: 02/26/2026
• Supplement Report FDA Received Date: 03/05/2026; 04/30/2026; 05/21/2026; 06/01/2026; 06/09/2026; 06/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/03/2025
• 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: Death
• Patient Age: 69 YR
• Patient Sex: Male