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

Catalog Number	1000080
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hematoma (1884); Hemorrhage/Blood Loss/Bleeding (1888); Ischemia (1942)
Date of Event	03/20/2026
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
An impella cp device was inserted into the left femoral artery in a 73-year-old female patient with a past medical history of coronary artery disease (cad), presenting in acute myocardial infarction (ami) and cardiogenic shock (cgs), in an out-of-hospital cardiac arrest requiring cardiopulmonary resuscitation (cpr), in scai stage e shock, and on a ventilator for respiratory support, prior to initiation of support.While the patient was in the intensive care unit (icu), there were no pedal pulses.No hematoma to the groin noted; however, there was oozing from the left forward angle suture.The patient had a suspected retroperitoneal bleed from the right femoral sheath site (non-impella site).The physician stated that the right side was a previous sheath site and a femstop was placed there.The left impella groin site was soft, clean, dry, and intact.Three hours after impella support, the family withdrew care, and the patient expired on support.The impella functioned at p-3 at 3.0l/min as intended.Bleeding is a known risk due to the impella's anticoagulation and purge requirements.Limb ischemia can be influenced by patient-specific factors such as peripheral vascular disease, underlying critical illness, hemodynamic instability, anticoagulation status, vasopressor support, and vascular access characteristics.The impella is conservatively being reported for death; however, is unlikely to have contributed to the patient's death, which was most likely due to the clinical condition of a critically ill patient in acute myocardial infarction and cardiogenic shock, complicated by stage e shock.
Additional Manufacturer Narrative
Section d4 catalog number was corrected.H6 codes have been updated and e0505 is no longer applicable.
Additional Manufacturer Narrative
D4 serial and primary udi number were revised.H6 component code, type of investigation, investigation findings, and investigation conclusions were updated accordingly based on investigation findings.H11 the impella device was not returned, and the investigation has been completed.Investigation summary - ischemia: the root cause of the injury was unable to be determined due to insufficient clinical details.Major bleed/access site adverse event: the cause of major bleed/access site adverse event was unable to be determined as limited clinical details were provided and no product was returned for review.

• 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 Contact: derek sammarco ; 22 cherry hill drive; danvers, MA 01923 ; 7814934967
• MDR Report Key: 24741067
• Report Number: 1220648-2026-06155
• Device Sequence Number: 8704246
• Product Code: OZD
• UDI-Device Identifier: 00813502012279
• UDI-Public: (01)00813502012279(17)280131(10)2027840695
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• 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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 1000080
• Device Lot Number: 2027840695
• 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: 03/20/2026
• Supplement Date Received by Manufacturer: 04/14/2026; 05/15/2026
• Initial Report FDA Received Date: 03/31/2026
• Supplement Report FDA Received Date: 04/17/2026; 05/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/11/2026
• 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: Death
• Patient Age: 73 YR
• Patient Sex: Female
• Patient Weight: 61 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White