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	Difficult to Insert (1316); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Anemia (1706)
Date of Event	04/30/2026
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 40-year-old male with acute myocardial infarction complicated by cardiogenic shock was supported with an impella cp (sn (b)(6)) implanted percutaneously via the right femoral artery on (b)(6) 2026 at 16:00.During support, the patient experienced a drop in hemoglobin to 6.4 g/dl on the night prior to explant, for which one unit of packed red blood cells was administered.The patient was successfully weaned from mechanical circulatory support.Following removal of the impella cp, angiography of the right common femoral artery demonstrated the impella access site was located above an anatomically low epigastric artery.Due to concern for potential bleeding and posterior hematoma, contralateral access was obtained, the perclose sutures were tightened, and a 6f angio-seal closure device was deployed.Final angiography from the contralateral access site was unremarkable with no evidence of active bleeding.Based on the available information, this complaint involves a report of anemia requiring transfusion in a patient supported with an impella cp for ami with cardiogenic shock, with the patient injury attributed to impella per reporter assessment.Review of the information provided did not identify evidence of device malfunction, failure, or damage, and the device functioned as intended during use.Vascular anatomy, including a low epigastric artery, was noted as a contributing factor managed per standard interventional techniques.The device was not removed due to a failure mode, and the event is considered a patient injury without device involvement.Bleeding is consistent with access site complications as a result of large bore femoral procedures and the anticoagulation and purge requirements associated with impella support.It is unknown whether recommended best practices for access management were followed to mitigate the risk of bleeding.
Event or Problem Description
Additional information received on 05may2026 the anemia resolved with blood given.A 40-year-old male with acute myocardial infarction complicated by cardiogenic shock was supported with an impella cp (sn (b)(6)) implanted percutaneously via the right femoral artery on (b)(6) 2026 at 16:00.During support, the patient experienced a drop in hemoglobin to 6.4 g/dl on the night prior to explant, for which one unit of packed red blood cells was administered.The patient was successfully weaned from mechanical circulatory support.Following removal of the impella cp, angiography of the right common femoral artery demonstrated the impella access site was located above an anatomically low epigastric artery.Due to concern for potential bleeding and posterior hematoma, contralateral access was obtained, the perclose sutures were tightened, and a 6f angio-seal closure device was deployed.Final angiography from the contralateral access site was unremarkable with no evidence of active bleeding based on the available information, this complaint involves a report of anemia requiring transfusion in a patient supported with an impella cp for ami with cardiogenic shock, with the patient injury attributed to impella per reporter assessment.Review of the information provided did not identify evidence of device malfunction, failure, or damage, and the device functioned as intended during use.Vascular anatomy, including a low epigastric artery, was noted as a contributing factor managed per standard interventional techniques.The device was not removed due to a failure mode, and the event is considered a patient injury without device involvement.Bleeding is consistent with access site complications as a result of large bore femoral procedures and the anticoagulation and purge requirements associated with impella support.It is unknown whether recommended best practices for access management were followed to mitigate the risk of bleeding.
Additional Manufacturer Narrative
The investigation of the reported failure mode has been completed.No product was received for evaluation.Patient-device interaction (anemia ): the root cause of the injury was not determined due to insufficient clinical details.B1 product problem omitted.H6 medical device problem code difficult/unable to insert through other device was omitted.

• 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: 25095336
• Report Number: 1220648-2026-07567
• Device Sequence Number: 13205949
• Product Code: OZD
• UDI-Device Identifier: 00813502011876
• UDI-Public: (01)00813502011876(17)260630(10)2025547853
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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

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 Expiration Date: 06/30/2026
• Device Catalogue Number: 0048-0045
• Device Lot Number: 2025547853
• 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: 05/01/2026
• Supplement Date Received by Manufacturer: 05/05/2026
• Initial Report FDA Received Date: 05/06/2026
• Supplement Report FDA Received Date: 05/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/12/2024
• 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: 40 YR
• Patient Sex: Male
• Patient Weight: 57 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White