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

Model Number	IMPELLA CP C7 W V3 GWRU SET, US
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hematoma (1884); Hemolysis (1886); Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	04/29/2021
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.Instructions for use for the related event are as follows: 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 that a patient with known coronary artery disease (cad) was presented to the medical facility with increasing chest pains and st elevation myocardial infarction (stemi).A chest x-ray (cxr) revealed a pulmonary edema and severe left anterior descending artery (lad) lesion between two (2) separate aneurysmal areas.The decision was made to implant the impella device.Groin site bleeding was identified.The site was dressed, and angle matching technique was utilized to resolve this issue.It was reported that the patient¿s urine was dark red in color and a large hematoma was observed at the right radial angio access point.It was reported that the impella device was repositioned to manage hemolysis and manual pressure was held at access site to manage these access site bleeding.Heparin was held as the patient suffered from a gastrointestinal (gi) bleed and restarted as the gi bleed improved.Weaning was successful, and the device was explanted.The procedural outcome is the patient survived surgery.

• 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 ; 22 cherry hill dr.; danvers, MA 01923
• MDR Report Key: 20012437
• Report Number: 1220648-2024-15552
• Device Sequence Number: 7123639
• Product Code: OZD
• UDI-Device Identifier: 00813502011388
• UDI-Public: (01)00813502011388(10)1486611(17)220630
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 08/17/2024

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: 06/30/2022
• Device Model Number: IMPELLA CP C7 W V3 GWRU SET, US
• Device Catalogue Number: 0048-0032
• Device Lot Number: 1486611
• 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: 04/29/2021
• Initial Report FDA Received Date: 08/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/27/2020
• 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: Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White