MAUDE Adverse Event Report: Abiomed, Inc. - 1220648; Introducer, Catheter (Introducer)

Catalog Number	2000342
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	08/03/2026
Type of Reportable Event	Death
Event or Problem Description
Clinical narrative: an impella rp flex was inserted (site not reported) in a 75-year-old male patient presenting with acute myocardial infarction/ cardiogenic shock.The patient¿s comorbidities were coronary artery, coagulopathy, liver dysfunction, and calcification.The patient¿s clinical state prior to initiation of support was society for cardiovascular angiography and interventions (scai) shock stage d identified as clinical evidence of shock that worsens or fails to improve despite escalation therapies.The patient was on inotropes, vasopressors, and respiratory support.Baseline clinical parameters included a lactate level of 9.7 mmol/l and central venous pressure (cvp) of 5 mmhg.The impella rp flex was operating at p-8 and providing approximately 3.7 l/min of flow with a sodium bicarbonate in 5% dextrose purge solution.During support, the patient experienced bleeding at the venous access site around the sheath after insertion in the catheterization laboratory.The patient was receiving anticoagulant therapy with procedural iv heparin, had a reported act of >300 at the time of bleeding, and had contributing factors including coagulopathy, liver dysfunction, and calcification.Hemostasis was managed with a targeted lower activated clotting time (act)/p partial thromboplastin time (ptt) goal.Additionally, severe tricuspid regurgitation was reported, with possible impingement of the anterior tricuspid valve leaflet by the impella catheter.The device was not removed due to the reported events.Following continued clinical deterioration, care was withdrawn, and the patient expired six days after device implantation.The bleeding was likely due to the elevated act and anticoagulant therapies.The patient¿s complex presentation, including cardiogenic shock and significant comorbid conditions, and the possible impingement of the anterior tricuspid valve leaflet by the impella catheter, may have contributed to the reported adverse events and fatal outcome.
Additional Manufacturer Narrative
The device is not available.This is one of two related reports.This report represents the introducer and another report has been submitted to represent the impella rp flex.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.

• Common Device Name: Introducer, Catheter (Introducer)
• 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 ; +1(781)493-4967
• MDR Report Key: 50279518
• Report Number: 1220648-2026-11668
• Device Sequence Number: 15895545
• Product Code: DYB
• UDI-Device Identifier: 00813502010411
• UDI-Public: (01)00813502010411(17)280428(10)S9732171
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: P140003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• 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: 2000342
• Device Lot Number: S9732171
• 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: 08/03/2026
• Initial Report FDA Received Date: 08/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/28/2025
• 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: 75 YR
• Patient Sex: Male
• Patient Weight: 149 LB