MAUDE Adverse Event Report: ABIOMED, INC. - 1220648 IMPELLA; INTRODUCER, CATHETER (INTRODUCER)

Catalog Number	2000342
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Thromboembolism (2654)
Date of Event	05/19/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
An impella rp flex device was inserted via the right femoral venous approach in a 73-year-old male patient for the indication of right ventricular failure in the setting of post-operative left ventricular assist device placement.The patient¿s past medical history was significant for renal insufficiency requiring dialysis.The patient¿s clinical state prior to initiation of support was consistent with society for cardiovascular angiography and interventions (scai) stage e cardiogenic shock.During impella rp flex support, it was reported that the patient had low platelet levels, and a clinical decision was made to utilize a bicarbonate-based purge solution without systemic anticoagulation.The purge solution consisted of 5 percent dextrose in water with 25 milliequivalents per liter of sodium bicarbonate.Initial device flows were approximately 3.0 liters per minute.Overnight, device flows gradually decreased, accompanied by a decrease in purge flow and an increase in purge pressure.There were no reported kinks observed in the purge line tubing.The absence of systemic anticoagulation was identified as a contributing factor in this clinical context.It was noted tpa was not added.The patient was subsequently taken to the cardiac catheterization laboratory, where the impella rp flex device was removed.Upon removal, thrombus was observed on the cannula and within the introducer sheath.The introducer sheath was left in place.Following removal of the impella rp flex device, a protek duo system was placed to provide continued right ventricular mechanical circulatory support.The patient survived to device explant.
Additional Manufacturer Narrative
The root cause of the thromboembolism was unable to be determined due to insufficient clinical details.The introducer batch passed all incoming inspection checks.

• Brand Name: IMPELLA
• Common Device Name: INTRODUCER, CATHETER (INTRODUCER)
• 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: 25522149
• Report Number: 1220648-2026-08909
• Device Sequence Number: 13418567
• Product Code: DYB
• UDI-Device Identifier: 00813502010411
• UDI-Public: (01)00813502010411(17)270531(10)S9131520(11)240628
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: 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: 2000342
• Device Lot Number: S9131520
• 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: 05/19/2026
• Initial Report FDA Received Date: 06/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/28/2024
• 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: 73 YR
• Patient Sex: Male
• Patient Weight: 110 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White