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	Increase in Pressure (1491)
Health Effect - Clinical Code	Cardiovascular Dysfunction/Insufficiency (4445)
Date of Event	07/13/2023
Type of Reportable Event	Death
Event or Problem Description
The complainant reported that they encountered a purge pressure high/purge pressure blocked alarm during impella support.The purge cassette was replaced to initially resolve the alarms; however, the issue returned a short time after.Two mg tpa and 50 cc of water were hung as purge fluid and the alarms were again resolved.Additional information noted the patient expired.There is not enough information to exclude the impella device as an associated factor in the patient's demise.
Additional Manufacturer Narrative
The investigation into the reported issue has been completed.No device was received for evaluation.The cause of the high purge pressure issue was most likely biomaterial based on provided clinical information and data log review.As noted in the impella ifu: impella rp with smartassist system section: using the automated impella controller with the impella rp with smartassist system catheter ¿unresolved purge pressure high alarm if not resolved by the recommendations provided, high purge pressure¿which triggers the ¿purge pressure high¿ alarm message¿could be an indication of a kink in the impella rp with smartassist system catheter.In this case, the motor is no longer being purged and may eventually stop.Monitor motor current and consider replacing the impella rp with smartassist system catheter whenever a rise in motor current is seen.¿ this report is being filed as part of a retrospective review of historical records.

• 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: 20575547
• Report Number: 1220648-2024-21619
• Device Sequence Number: 20959394
• Product Code: PYX
• UDI-Device Identifier: 00813502011029
• UDI-Public: (01)00813502011029(10)2023184786(17)240229
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P140003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• 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: 02/29/2024
• Device Model Number: IMPELLA RP
• Device Catalogue Number: 004334
• Device Lot Number: 2023184786
• 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: 07/13/2023
• Initial Report FDA Received Date: 10/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/17/2022
• 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: 78 YR
• Patient Sex: Female