MAUDE Adverse Event Report: ABIOMED, INC. - 1220648 IMPELLA; TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP

Catalog Number	0048-0045
Medical Device Problem Codes	Increase in Pressure (1491); Deformation Due to Compressive Stress (2889); Device Sensing Problem (2917); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Hemolysis (1886)
Date of Event	04/17/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by abiomed inc, or its employees that the report constitutes an admission that the product, abiomed inc, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
Clinical narrative: a 77-year-old male with acute myocardial infarction and cardiogenic shock (pre-support clinical state consistent with scai shock stage d) was supported with an impella cp inserted percutaneously via the right femoral artery on (b)(6) 2026 at 10:48 am.During support, a discrepancy was noted with the aortic placement signal reading approximately 20¿30 mmhg below the concurrently measured arterial line pressure.The bedside nurse reported a sudden change in device performance characterized by a decrease in pump flow to approximately 3 ml/hr and an increase in purge pressure to greater than 800 mmhg.The bedside nurse reported a sudden change in device performance characterized by a decrease in pump flow to approximately 3 ml/hr and an increase in purge pressure to greater than 800 mmhg.Line tracing identified the purge tubing wrapped around the patient¿s foot, and the tubing was subsequently freed; however, after approximately 15 minutes, there was minimal improvement in purge pressure or pump flow.Concurrently, the local clinical team reported laboratory findings concerning for hemolysis, including acute anuria, elevated ldh, rising creatinine, and increased total bilirubin.The impella cp was electively explanted on (b)(6) 2026 at 12:30 pm, with manual pressure held to achieve hemostasis.Based on the available information, this complaint documents decreased impella cp performance associated with high purge pressure and low placement signal in the setting of observed purge tubing kinking and subsequent laboratory findings concerning for hemolysis.The patient survived.Hemolysis may be influenced by patient specific factors such as critical illness, underlying cardiac dysfunction, hemodynamic instability, renal function, anticoagulation status, and potential device position.
Additional Manufacturer Narrative
This follow-up report is being submitted to document that the device has been returned to the manufacturer for investigation.Section d9 has been updated to reflect that the product was returned for investigation.
Additional Manufacturer Narrative
This follow up mdr is being submitted to document that the device involved in the reported event has been identified as available for return.At the time of this submission, the device has not yet been returned to the manufacturer and therefore has not been evaluated.A subsequent follow up mdr will be submitted if additional information becomes available following device receipt and evaluation.

• Brand Name: IMPELLA
• Common Device Name: TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP
• Manufacturer (Section D): ABIOMED, INC. - 1220648; 22 cherry hill drive; danvers MA 01923
• Manufacturer (Section G): DANVERS
• Manufacturer Contact: derek sammarco ; 22 cherry hill drive; danvers, MA 01923 ; 7814934967
• MDR Report Key: 24967249
• Report Number: 1220648-2026-07069
• Device Sequence Number: 18732877
• Product Code: OZD
• UDI-Device Identifier: 00813502011876
• UDI-Public: (01)00813502011876(17)270731(10)2026744792
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: P140003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup

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 Catalogue Number: 0048-0045
• Device Lot Number: 2026744792
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/17/2026
• Supplement Date Received by Manufacturer: 04/21/2026; 04/27/2026
• Initial Report FDA Received Date: 04/23/2026
• Supplement Report FDA Received Date: 04/27/2026; 04/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/02/2025
• 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: Other
• Patient Age: 77 YR
• Patient Sex: Male
• Patient Weight: 91 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White