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	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Stroke/CVA (1770)
Date of Event	09/25/2021
Type of Reportable Event	Death
Event or Problem Description
The user facility reported a patient in acute myocardial infarction/cardiogenic shock was implanted with an impella cp device for mechanical circulatory support.While on support, the patient experienced a stroke.Survival outcome at explant noted the patient expired.Medical safety review of the event noted there is not enough information to exclude the impella device as an associated factor in the patient's demise.
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.As noted in the impella ifu: impella cp with smart assist system 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).¿ section: warnings, cautions & precautions: ¿to reduce the possibility of fibers being drawn into the impella, customers should avoid exposing the inlet and cannula section of the impella heart pumps to any surfaces or fluid baths where the device can come into contact with loose or floating fibers.¿ this report is being filed as part of a retrospective review of historical records.

• 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: 20092068
• Report Number: 1220648-2024-17041
• Device Sequence Number: 18083724
• Product Code: OZD
• UDI-Device Identifier: 00813502011388
• UDI-Public: (01)00813502011388(10)1469923(17)220331
• Combination Product (Y/N): N
• Initial Reporter State: NM
• 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
• Report Date (Section B): 08/28/2024

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: 03/31/2021
• Device Model Number: IMPELLA CP
• Device Catalogue Number: 0048-0032
• Device Lot Number: 1469923
• 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: 09/25/2021
• Initial Report FDA Received Date: 08/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/27/2020
• 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: Death
• Patient Age: 37 YR
• Patient Sex: Male