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

Catalog Number	1000323
Medical Device Problem Codes	Pumping Stopped (1503); Device Damaged by Another Device (2915)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/17/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Updated clinical narrative: an impella rp flex with smartassist was inserted via the right femoral vein in a 70-year-old female patient presenting with acute myocardial infarction complicated by cardiogenic shock (ami/cgs) classified as society for cardiovascular angiography and interventions (scai) shock stage e.Scai stage e is defined as refractory shock or actual/impending circulatory collapse in which the body fails to respond to maximal lifesaving therapies, leading to full organ shutdown.Prior to impella support, the patient was receiving inotropic, vasopressor, respiratory support as well as an impella cp that was placed approximately 15 minutes prior to the rp implant.A history of cardiopulmonary resuscitation (cpr) was also reported.Following implantation of the impella rp flex, a venous access line was being placed for swan-ganz catheter insertion.During sheath placement, the treating provider reportedly released control of a microcatheter wire, allowing the wire to migrate intravascularly and become entrained within the impella rp flex.It was reported that the wire was not near the pump inlet at the time of the event.The impella rp flex was operating as intended at performance level 9 with flows of approximately 4.2 liters per minute when the event occurred.It was then reported that the impella device experienced a pump stop resulting in the device removal.Following removal a second impella rp flex was successfully implanted through the same access site.No adverse events or clinical consequences to the patient were reported following device exchange.No additional pump performance metrics or purge solution information were reported.
Additional Manufacturer Narrative
A4 weight is unknown 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.Related medical device reports: this impella rp device report is one of two devices associated with the event.Refer to the related manufacturer report number as noted in section h10 for the medical device report on the impella cp.

• 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 (Section G): Danvers
• Manufacturer Contact: derek sammarco ; 22 cherry hill drive; danvers, MA 01923 ; +1(781)493-4967
• MDR Report Key: 50896078
• Report Number: 1220648-2026-13344
• Device Sequence Number: 16142725
• Product Code: PYX
• UDI-Device Identifier: 00813502012811
• UDI-Public: (01)00813502012811(17)280127(10)2027884198
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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: 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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 1000323
• Device Lot Number: 2027884198
• 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: 09/17/2026
• Initial Report FDA Received Date: 09/25/2026
• 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: SWAN
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR
• Patient Sex: Female
• Patient Race: White