MAUDE Adverse Event Report: ABIOMED, INC. IMPELLA CP; TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP

Model Number	IMPELLA CP
Medical Device Problem Code	Restricted Flow rate (1248)
Health Effect - Clinical Codes	Arrhythmia (1721); Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	05/13/2021
Type of Reportable Event	Serious Injury
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.This report is being filed as part of a retrospective review of historical records.As noted in the impella ifu: impella cp with smart assist system.Section: general patient care considerations: ¿assess access site for bleeding and hematoma.¿ section: entering cardiac output: use of the repositioning sheath and peel-away introducer.¿remove the peel-away introducer completely from the artery over the catheter shaft to prevent trauma and significant bleeding and apply manual pressure above the puncture site.¿ section: potential adverse events (united states): ¿acute renal dysfunction, aortic valve injury, bleeding, cardiogenic shock, cerebral vascular accident/stroke, death, hemolysis, limb ischemia, myocardial infarction, renal failure, thrombocytopenia and cardiac or vascular injury (including ventricular perforation).¿.
Event or Problem Description
The complainant reported a patient in acute myocardial infarction/cardiogenic shock was implanted with an impella cp device for mechanical circulatory support.Hemostasis was achieved.While on support the patient experienced continuous suction alarms.Echo had been obtained prior to that and per cardiologist impella was in ¿ok position.¿ the patient started having runs of wide complex tachycardia with a pulse after arriving.The provider agreed to get another echo given new persistent suction alarms now on p2 and arrhythmias.Impella noted at 4cm from av annulus, repositioned and measured 3.6 cm from av annulus.New cm marking at 90.5.P level increased to p4, but the patient continues to have suction.The patient has known mitral regurgitation (mr), difficult to assess at this time with color doppler.Suction alarms disabled, notified provider and nurse at bedside to monitor closely for signs of hemolysis.The patient also had hemostasis which had been achieved with the two per close sutures that had been placed at time of insertion.The patient was successfully weaned from the impella and the device explanted.
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 CP
• Common Device Name: TEMPORARY NON-ROLLER TYPE LEFT 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: 20092828
• Report Number: 1220648-2024-17086
• Device Sequence Number: 7838060
• Product Code: OZD
• UDI-Device Identifier: 00813502011388
• UDI-Public: (01)00813502011388(10)1428321(17)210831
• 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: 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): 05/23/2025

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: 08/31/2021
• Device Model Number: IMPELLA CP
• Device Catalogue Number: 0048-0032
• Device Lot Number: 1428321
• 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: 05/13/2021
• Supplement Date Received by Manufacturer: 02/14/2025
• Initial Report FDA Received Date: 08/28/2024
• Supplement Report FDA Received Date: 05/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/13/2019
• 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: Life Threatening; Required Intervention
• Patient Age: 54 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White