MAUDE Adverse Event Report: Abiomed, Inc. - 1220648 Impella; Temporary Non-Roller Type Left Heart Support Blood Pump

Catalog Number	0048-0045
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	10/19/2022
Type of Reportable Event	Serious Injury
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 via the right femoral artery in a 79 year-old male patient undergoing a protected percutaneous coronary intervention (ppci).The patient's clinical state prior to initiation of support was unknown for society for cardiovascular angiography and interventions (scai) shock stage.The patient's medical history was notable for coronary artery disease (cad).During the procedure, single-access technique was utilized, and the patient remained on impella support for approximately 2 hours.After the ppci the device was successfully weaned and explanted.The activated clotting time (act) was reported at 306 seconds at the time of device removal.Post-procedure, a gradual decline in hemoglobin was observed, which the treating providers felt was likely related to the impella.Hemoglobin decreased to 7.8 g/dl.Transfusion of 1 unit of packed red blood cells (prbc) was given, with improvement to 9.3 g/dl was reported.No overt source of bleeding was identified.However, minor bleeding from an internal jugular (ij) sheath was reported and managed with local epinephrine and lidocaine administration.Two days following the procedure, the patient experienced an asystolic cardiac arrest and required transfusion of an additional 2 units of packed red blood cells.Further details regarding the relationship between the subsequent cardiac arrest and the prior hemoglobin decline were not reported.The patient outcome was reported as survived with no additional adverse events reported.No pump metrics or purge solution was reported.Based on the available information, the bleeding and subsequent decline in hemoglobin requiring a blood transfusion cannot be dissociated, as the bleeding occurred post procedure.The subsequent cardiac arrest two days later and the impella cannot be dissociated, as a drop in hemoglobin may be a contributing factor to cardiac arrest.

• 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 ; +1(781)493-4967
• MDR Report Key: 50300721
• Report Number: 1220648-2026-11705
• Device Sequence Number: 21507401
• Product Code: OZD
• UDI-Device Identifier: 00813502011876
• UDI-Public: (01)00813502011876(11)220930(17)240731(10)2023254643
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P140003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial

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 Expiration Date: 07/31/2024
• Device Catalogue Number: 0048-0045
• Device Lot Number: 2023254643
• 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: 08/07/2026
• Initial Report FDA Received Date: 08/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/30/2022
• 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 Age: 79 YR
• Patient Sex: Male
• Patient Race: White