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

Catalog Number	1000323
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	09/10/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
An impella rp flex was inserted percutaneously via right femoral vein access site in 78-year-old female patient for pulmonary embolism.The patient¿s comorbidities were coronary artery disease.The patient¿s clinical state prior to initiation of support was society for cardiovascular angiography intervention (scai) shock stage e identified as the body fails to respond to maximal lifesaving therapies.The patient was on inotropes and vasopressors.The patient was receiving anticoagulation therapy with a heparin infusion, monitored by ptt, and the anticoagulation level at the time of the event was reported as supra-therapeutic.On day 1 of support and after transfer to the intensive care unit (icu), bleeding occurred at the access site around the sheath.The bleeding was managed with manual pressure and placement of a surgical stitch, resulting in resolution of the event.The patient received two units of blood products.The impella rp flex remained in place and was not removed due to the reported bleeding event.On day 2 of support, the device was successfully weaned and explanted.The patient survived and was reported as stable.The impella system was operating as intended at performance (p) level p-6, providing approximately 2.3 l/min flow with a 5% dextrose in water sodium bicarbonate purge solution.The reported access site bleeding occurred in the setting of anticoagulation therapy with supra-therapeutic coagulation parameters and was managed successfully with manual pressure, surgical suturing, and blood transfusion support.The reported access site bleeding is a known procedural complication associated with large-bore vascular access and anticoagulation therapy.
Additional Manufacturer Narrative
Product complaint # (b)(4).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.

• Brand Name: Impella
• Common Device Name: Temporary Non-Roller Type Right 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: 50803734
• Report Number: 1220648-2026-13023
• Device Sequence Number: 20993516
• Product Code: PYX
• UDI-Device Identifier: 00813502012811
• UDI-Public: (01)00813502012811(17)270131(10)2026687381
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P170011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: 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 Catalogue Number: 1000323
• Device Lot Number: 2026687381
• 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: 09/10/2026
• Initial Report FDA Received Date: 09/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/16/2025
• 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: Required Intervention
• Patient Age: 78 YR
• Patient Sex: Female
• Patient Weight: 193 LB
• Patient Race: White