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 Codes	Hemorrhage/Blood Loss/Bleeding (1888); Ischemia (1942)
Date of Event	06/14/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D.6b the exact date of explant is unknown.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 manufacturer device report will be filed.As noted in the impella instructions for use: 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).¿ 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 cp device for mechanical circulatory support.While on support, the right foot well perfused despite no pulses.Two days later, the patient had significant bleeding overnight at the impella/groin site.The patient is getting transfused.The patient was found to have the venous sheath almost out and kinked clearly causing the bleed.The physician refloated the sheath which sealed the groin and the impella was explanted.The patient survived the procedure.

• 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: 20005632
• Report Number: 1220648-2024-15480
• Device Sequence Number: 7123417
• Product Code: OZD
• UDI-Device Identifier: 00813502011388
• UDI-Public: (01)00813502011388(10)1469291(17)220331
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P140003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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): 08/17/2024

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: 03/31/2022
• Device Model Number: IMPELLA CP
• Device Catalogue Number: 0048-0032
• Device Lot Number: 1469291
• 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: 06/14/2021
• Initial Report FDA Received Date: 08/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/24/2020
• 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
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White