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	08/20/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Impella rp flex was inserted via the left femoral vein in a 60-year-old male patient for acute myocardial infarction/cardiogenic shock (ami/cgs).The patient's comorbidities were not reported.The patient's clinical state prior to initiation of support was society for cardiovascular angiography and interventions (scai) shock stage d, deteriorating, identified as worsening despite initial therapy with evidence of ongoing hemodynamic compromise.Therapies provided prior to support included inotropes, vasopressors, and respiratory support.Impella rp flex introducer insertion was initially attempted via the right internal jugular vein using serial dilation insertion best practices.Following unsuccessful advancement of the introducer, a small skin incision was made at the access site in attempt to facilitate sheath passage, however, remained unsuccessful.The healthcare provider attributed the patient's thick skin to the inability to advance the introducer.The left femoral vein was subsequently prepared as alternate access.During preparation for the alternate access site, score marks were observed on the distal end of the sheath dilator, presumed to have resulted from contact with the scalpel used during the skin incision.A new impella rp flex introducer kit was obtained and access was successful.On day three of support, following removal of a temporary pacemaker and pulmonary artery catheter from the right femoral vein, the patient experienced a decrease in hemoglobin from 9.2 g/dl to 7.5 g/dl and a decrease in platelet count from 75 to 44.Activated clotting time (act) at the time of the event was 164 seconds.No bleeding, bruising, or hematoma was reported at the impella access site.Blood products were administered in response to the reported hematologic changes.The provider reported concern that the back wall of the common femoral vein may have been perforated during insertion of the temporary pacemaker and pulmonary artery catheter, however, elected to explant the impella rp flex out of an abundance of caution.At the time of the event, the impella rp flex was providing hemodynamic support within the expected range at performance level p5 with flows of 2.4 l/min.The purge solution consisted of 5% dextrose in water with 25 meq/l sodium bicarbonate.The device was subsequently explanted, and the patient survived to device explant.Although the healthcare provider did not attribute the reported bleeding event to the impella rp flex, the event is being reported due to the anatomical proximity of the bilateral femoral venous access sites and the inability to conclusively dissociate device involvement based on the available information.
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.

• 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: 50569136
• Report Number: 1220648-2026-12425
• Device Sequence Number: 10507361
• Product Code: PYX
• UDI-Device Identifier: 00813502012811
• UDI-Public: (01)00813502012811(17)280127(10)2027884355
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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,Followup
• Report Date (Section B): 09/17/2026

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: 2027884355
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/23/2026
• Supplement Date Received by Manufacturer: 09/16/2026
• Initial Report FDA Received Date: 09/02/2026
• Supplement Report FDA Received Date: 09/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/14/2026
• 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
• Concomitant Medical Products and Therapy/Usage Dates: PA Catheter; Temporary Pacemaker
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 60 YR
• Patient Sex: Male
• Patient Weight: 138 LB
• Patient Race: Black Or African American