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

Catalog Number	0052-3046
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hematoma (1884); Ischemia (1942)
Date of Event	03/15/2026
Type of Reportable Event	Death
Additional Manufacturer Narrative
H6: updated codes based on the results of the investigation.H11: updated based on the results of the investigation and added clinical review.The cause of the access site adverse event was not determined due to insufficient clinical details.
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 right femoral artery in an 87-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 scai stage c shock, on multiple inotropes and vasopressors, and on a ventilator for respiratory support, prior to initiation of support.The impella was inserted for ventricular support for a protected percutaneous coronary intervention (pci).During the procedure, the peel-away sheath was left in place by the physician.A run-off angiogram was performed prior to leaving the cath lab to confirm flow to the right lower extremity.A distal perfusion catheter was placed.A stable hematoma was noted at the access site.Six days after impella insertion, the family withdrew care, and the patient expired on support.The impella functioned at p-4 at 2.6l/min as intended.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.Bleeding (hematoma) is a known risk due to the impella's anticoagulation and purge requirements.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 c shock.
Additional Manufacturer Narrative
Remove h6.Health effect - impact code f19 for surgical intervention; inadvertently reported on initial report.
Event or Problem Description
An impella cp device was inserted into the right femoral artery in a 87-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 scai stage c shock, on multiple inotropes and vasopressors, and on a ventilator for respiratory support, prior to initiation of support.The impella was inserted for ventricular support for a protected percutaneous coronary intervention (pci).During the procedure, the peel-away sheath was left in place by the physician.A run-off angiogram was performed prior to leaving the cath lab to confirm flow to the right lower extremity.The patient did not have leg ischemia as the patient had a distal perfusion catheter that was placed prophylactically to mitigate limb ischemia due to the peel-away sheath being left in place.A stable hematoma was noted at the access site.Six days after impella insertion, the family withdrew care, and the patient expired on support.The impella functioned at p-4 at 2.6l/min as intended.Bleeding (hematoma) is a known risk due to the impella's anticoagulation and purge requirements.The death is conservatively being reported; 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 c shock.
Additional Manufacturer Narrative
B2 death and date and death updated.The exact date of death is unknown but has been captured as the date of explant.If additional information becomes known, a supplemental report will be submitted.B5 updated to include additional information.H6 health effect - impact code f02 added.H6 health effect - clinical code e0509 ischemia omitted.

• 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: 24679890
• Report Number: 1220648-2026-05841
• Device Sequence Number: 13193363
• Product Code: OZD
• UDI-Device Identifier: 00813502011678
• UDI-Public: (01)00813502011678(17)280531(10)S9956351
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,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: 0052-3046
• Device Lot Number: S9956351
• 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: 03/15/2026
• Supplement Date Received by Manufacturer: 03/30/2026; 04/02/2026; 04/30/2026
• Initial Report FDA Received Date: 03/24/2026
• Supplement Report FDA Received Date: 04/03/2026; 04/13/2026; 05/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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; Required Intervention
• Patient Age: 87 YR
• Patient Sex: Female
• Patient Weight: 96 KG
• Patient Ethnicity: Hispanic
• Patient Race: White