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	Positioning Failure (1158)
Health Effect - Clinical Code	Cardiovascular Dysfunction/Insufficiency (4445)
Date of Event	06/10/2022
Type of Reportable Event	Death
Additional Manufacturer Narrative
The investigation for the reported positioning issue has been completed.The impella device was not received from the customer and therefore, an evaluation of the device was not possible.However, information provided was sufficient to determine a root cause.The root cause of the delivery issues was patient movement.This report is being filed as part of a retrospective review of historical records.
Event or Problem Description
The complainant reported a patient in acute myocardial infarction/cardiogenic shock was implanted with an impella rp device for mechanical circulatory support.While on support the device lost optimal position.After multiple attempts were made to reposition the device, the decision was made to replace the device with another impella rp device.Additional information was provided that noted care was withdrawn and the patient expired.There is not enough information to exclude the impella device as an associated factor in the patient's demise.

• 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
• MDR Report Key: 20575365
• Report Number: 1220648-2024-21609
• Device Sequence Number: 8575336
• Product Code: PYX
• UDI-Device Identifier: 00813502011029
• UDI-Public: (01)00813502011029(10)2023204616(17)240331
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: P170011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• 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
• Report Date (Section B): 10/30/2024

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: 03/31/2024
• Device Model Number: IMPELLA RP
• Device Catalogue Number: 004334
• Device Lot Number: 2023204616
• 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: 06/10/2022
• Initial Report FDA Received Date: 10/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/16/2022
• Is the Device Labeled for Single Use? (Y/N): No
• 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: 79 YR
• Patient Sex: Male
• Patient Ethnicity: Hispanic