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	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Renal Failure (2041)
Date of Event	01/12/2022
Type of Reportable Event	Death
Additional Manufacturer Narrative
The impella device has not been received from the customer, therefore, investigation of the device has not been possible.Should the device or any new information be received, a supplemental mdr will be filed.Instructions for use state the following: impella rp with smart assist system with automated impella controller.Section: warnings and cautions.¿make sure there is no bleeding at the transition from the repositioning sheath to the internal jugular vein.Close and dress the wound.¿be sure that the stopcock on the repositioning sheath is always kept in the closed position.Significant bleed back can result if the stopcock is open.¿ ¿make sure there is no bleeding at the transition from the repositioning sheath to the femoral vein.Close and dress the wound.¿.
Event or Problem Description
Us complainant reported the patient was on impella rp for hemodynamic support.While on support it was noted the patient was given lots of volume due to bleeding copious amounts from chest tubes.The patient received over 63 blood products.Hemodialysis was also successfully initiated.However, post dialysis the patient was much worse.Spouse decided to withdraw care, patient expired.

• 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: 20760464
• Report Number: 1220648-2024-23955
• Device Sequence Number: 15773689
• Product Code: PYX
• UDI-Device Identifier: 00813502011029
• UDI-Public: (01)00813502011029(10)1485188(17)220630
• Combination Product (Y/N): N
• Initial Reporter State: AR
• 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): 11/22/2024

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2022
• Device Model Number: IMPELLA RP
• Device Catalogue Number: 004334
• Device Lot Number: 1485188
• 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: 01/12/2022
• Initial Report FDA Received Date: 11/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/02/2020
• 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; Life Threatening; Death
• Patient Age: 77 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White