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

Catalog Number	1000323
Medical Device Problem Codes	Increase in Pressure (1491); Device Sensing Problem (2917)
Health Effect - Clinical Code	Thromboembolism (2654)
Date of Event	08/31/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
An impella rp flex with smartassist was inserted via the right femoral vein in a 76-year-old male patient presenting with pulmonary embolism.The patient's clinical state prior to initiation of support was society for cardiovascular angiography and interventions (scai) shock stage e.Scai stage e is identified as refractory shock or actual/impending circulatory collapse when the body fails to respond to maximal lifesaving therapies, leading to full organ shutdown.The patient was additionally noted to be receiving vasopressor, inotropic, and respiratory support prior to impella implantation.The patient's medical history was notable for coronary artery disease deep vein thrombosis (dvt).On day 2 of support, a persistent placement signal not reliable alarm was reported on the automated impella controller (aic).Echocardiographic imaging confirmed appropriate pump position, and motor current was reported as appropriate for the performance level.Activated clotting time (act) management was reported to be maintained throughout support.However, no act values were provided during the event.No troubleshooting measures were reported, and device performance metrics were not available on the day of the event.On day 3 of support, the patient was transferred to a secondary hospital.During transport, damage to the tubing was identified with a small pinhole leak noted.Upon arrival, the tubing was replaced and the leak resolved.However, purge flow was noted to have decreased from a previously reported 11 ml/hr to 4 ml/hr, which remained within abiomed's expected range of 2-30 ml/hr.Troubleshooting included a de-air procedure and removal and reinsertion of the purge cassette.However, neither intervention resolved the condition.The patient was reported to have a history or presence of mural thrombus within the right atrium or vena cava.This along with the reported dvt is a contraindication to the placement of the rp flex device.Following arrival at the receiving facility, purge flows were initially reported at 6 ml/hr and subsequently declined to below 1 ml/hr.A high purge pressure/purge system blocked alarm was displayed on the aic.Troubleshooting included replacement of the purge cassette.However, the condition did not resolve.Anticoagulation monitoring was reported using partial thromboplastin time (ptt), which was 70 seconds.It is uncertain how the reported ptt correlates to abiomed's recommended act range of 160-180 seconds during support.It was reported that tissue plasminogen activator (tpa) was administered for the high purge pressure as an off-label use to mitigate impact of biomaterial within the motor.However, the issue did not resolve.Due to the persistent purge system issue, the device was removed and the patient was subsequently a protek duo device was placed.The outcome was survival upon explant with no additional adverse events reported while on support, the impella rp flex with smartassist operated at performance level 7 with lower-than-expected flows of 0.5 liters per minute.The expected flow range at performance level 7 is approximately 2.7 to 3.4 liters per minute.The purge solution consisted of dextrose 5% in water with 25 milliequivalents per liter of sodium bicarbonate.The reported high purge pressure/purge system blocked alarm cannot be ruled out as related to the impella rp flex device, as the condition persisted despite multiple troubleshooting measures, resulting in device removal.The placement signal alarm resulted in no patient consequence in association with that event.
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: 50689968
• Report Number: 1220648-2026-12623
• Device Sequence Number: 12256003
• Product Code: PYX
• UDI-Device Identifier: 00813502012811
• UDI-Public: (01)00813502012811(17)280630(10)2027929429
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 1000323
• Device Lot Number: 2027929429
• 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: 08/31/2026
• Initial Report FDA Received Date: 09/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/06/2026
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 76 YR
• Patient Sex: Male
• Patient Weight: 198 LB
• Patient Race: White