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

Model Number	IMPELLA CP
Medical Device Problem Codes	Malposition of Device (2616); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Hemolysis (1886); Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	12/29/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The impella device has not been received from the customer.Therefore, investigation of the device is not possible.Should the device or any new information be received, a supplemental mdr will be filed.
Event or Problem Description
The user facility reported a 50 year old male patient who experienced oozing around the sheath after peel-away sheath removal.Oozing continued after transfer to the intensive care unit.Manual pressure was applied, and the sheath was secured with extra gauze to maintain forward tension and angle alignment.The patient¿s abdomen was taped to reduce pressure on the sheath.Act was 255 at the time.The cardiologist, interventionalist, and intensivist were notified and did not express concern.The introducer kit was discarded, and the patient remained on device support with flows and hemodynamics within normal limits.No additional information was provided.
Additional Manufacturer Narrative
Added selection e4.As it was omitted from the initial report that was submitted.
Additional Manufacturer Narrative
H6: updated codes based on the results of the investigation.H11: updated based on the results of the investigation.Investigation summary: the pump was not returned for investigation.Data log was not provided or retrieved from the remote server.Access site adverse event (minor bleed): clinical details indicate that oozing around the sheath was noted after the peel-away sheath was removed and continued after transfer to the intensive care unit (icu).Manual pressure was applied and the sheath was secured with extra gauze to maintain forward tension and angle matching.The stick was very high, and staff taped the patient¿s abdomen to alleviate pressure on the sheath.Activated clotting time (act) was 255 at the time of the bleed.The cause of the access site bleeding was most likely use-related, associated with high act values during the time of access site bleeding.Mechanical interaction with blood (hemolysis): clinical details indicate hemolysis began after impella support, with inlet position at the mitral valve as a contributing factor.The cause of the hemolysis was not determined without returned product investigation and sufficient clinical details.Device in wrong position: clinical details indicate echo showed the inlet was on the mitral valve, and the physician did not want to reposition.The cause of the positioning issue was not determined without returned product investigation and sufficient clinical details.Device history review: the pumppassed all the post sterile inspection checks.

• Brand Name: IMPELLA CP
• Common Device Name: TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP
• Manufacturer (Section D): ABIOMED, INC.; 22 cherry hill drive; danvers MA 01923
• Manufacturer Contact: derek sammarco ; 22 cherry hill drive; danvers, MA 01923 ; 7814934967
• MDR Report Key: 23999938
• Report Number: 1220648-2026-00280
• Device Sequence Number: 21465282
• Product Code: OZD
• UDI-Device Identifier: 00813502011180
• UDI-Public: (01)00813502011180(10)1457632(17)44865
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: P140003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/06/2026

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 Model Number: IMPELLA CP
• Device Catalogue Number: 000000000001000080
• Device Lot Number: 2026775637
• 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: 12/29/2025
• Supplement Date Received by Manufacturer: 01/14/2026; 02/05/2026
• Initial Report FDA Received Date: 01/07/2026
• Supplement Report FDA Received Date: 01/16/2026; 02/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 50 YR
• Patient Sex: Male
• Patient Weight: 87 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White