MAUDE Adverse Event Report: ABIOMED. INC. IMPELLA RP; TEMPORARY NON-ROLLER TYPE RIGHT HEART SUPPORT BLOOD PUMP

Model Number	IMPELLA RP
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/10/2021
Type of Reportable Event	Death
Additional Manufacturer Narrative
The impella device was not received from the customer, therefore, investigation of the device was not possible.Should the device or any new information be received, a supplemental mdr will be filed.Impella rp system with automated impella controller instructions for use for the related event are as follows: section: warnings, cautions and precautions: warnings "to reduce the risk of cardiac or vascular injury (including perforation) when manipulating the heart during cardiac surgery, evaluate the position of the pump using imaging guidance prior to manipulating the heart, and monitor position." "physicians should exercise special care when inserting the impella catheter during active cardiopulmonary resuscitation (cpr).In addition, active cpr maneuvers may change the position of the impella device, introducing the risk of cardiac or vascular injury (including ventricular perforation).Check that the pump is positioned correctly after cpr with chest x-ray guidance.".
Event or Problem Description
The complainant reported a patient with cardiomyopathy was implanted with an impella rp for mechanical circulatory support.It was reported that the patient was rolled while attempting to place hypothermia cooling pads on the patient early this morning.The patient was rolled and the impella rp was subsequently pulled from the (pa) pulmonary artery.A chest x-ray showed the outlet of the impella rp in the ra (right atrium).The physician decided that with the patient's condition, they would rather not move them to replace the pump.The rp was pulled and a mattress suture was placed on the access site.It was noted that the patient was withdrawn from care and expired.
Additional Manufacturer Narrative
This complaint has been identified as part of a retrospective review.Due to the limited clinical information and lack of available data/product the root cause of this investigation is not determined.

• Brand Name: IMPELLA RP
• Common Device Name: TEMPORARY NON-ROLLER TYPE RIGHT HEART SUPPORT BLOOD PUMP
• Manufacturer (Section D): ABIOMED. INC.; 22 cherry hill dr.; danvers MA 01923
• Manufacturer (Section G): ABIOMED, INC.; 22 cherry hill dr.; danvers MA 01923
• Manufacturer Contact: derek sammarco ; 22 cherry hill dr.; danvers, MA 01923
• MDR Report Key: 20759990
• Report Number: 1220648-2024-23942
• Device Sequence Number: 15768937
• Product Code: PYX
• UDI-Device Identifier: 00813502011029
• UDI-Public: (01)00813502011029(10)2022056133(17)230228
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: P170011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• 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): 05/27/2025

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 Expiration Date: 02/28/2023
• Device Model Number: IMPELLA RP
• Device Catalogue Number: 004334
• Device Lot Number: 2022056133
• 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: 05/10/2021
• Supplement Date Received by Manufacturer: 02/17/2025
• Initial Report FDA Received Date: 11/22/2024
• Supplement Report FDA Received Date: 05/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/02/2021
• 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: 74 YR
• Patient Sex: Male
• Patient Race: Black Or African American