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

Catalog Number	0048-0024-JP
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Stroke/CVA (1770); Hemorrhage/Blood Loss/Bleeding (1888); Low Blood Pressure/ Hypotension (1914)
Date of Event	05/27/2026
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
An impella cp was inserted via the right femoral artery in a 74-year-old male presenting with acute myocardial infarction (ami) and cardiogenic shock (cgs).The patient¿s comorbidities were unspecified, however, the patient required multiple vasopressors, inotropic support, and mechanical circulatory support (mcs), including an intra-aortic balloon pump (iabp) and extracorporeal mechanical circulation (ecmo).The patient was noted to be in scai stage d shock before initiation of impella cp support.It was reported that endovascular treatment was necessary prior to insertion of impella cp device due to "poor vascular characteristics of the lower extremities." it was also reported that the impella cp device was inserted through a 16f dry seal sheath.At the time of device placement, a slight difference in pupillary reflex between the left and right eyes was noted.6 days after impella insertion, a computed tomography (ct) scan of the brain was performed in response to the patient having a sudden drop in blood pressure.The scan revealed a subarachnoid hemorrhage.The impella cp device functioned as intended with a performance level of p-7 with flows at 3.0 liters per minute and purge solution of 5% dextrose in water with 20 units/ml of heparin added and no device-related issues were identified that impacted performance or patient management.Bleeding is a known risk associated with large-bore arterial access and anticoagulation in critically ill patients.After 7 days of support, the impella cp device was removed, as mechanical circulatory support was deemed no longer necessary based on improved cardiac function.The patient survived at explant.
Additional Manufacturer Narrative
Corrected information was provided in d3 (manufacturer fax), d10 (concomitant).Upon review, it was identified that it was inadvertently omitted from the initial report.Corrected information was provided in h6 (health effect - clinical code, impact code).Upon review, it was identified that surgical intervention and major bleed codes were updated to hypotension and serious injury.B5 is being updated to include new and corrected information that was not included in the initial report.The revised b5 provides a complete event narrative.H6: updated codes based on the results of the investigation.H11: updated based on the results of the investigation.The root cause of the injury was unable to be determined due to insufficient clinical details.
Event or Problem Description
It was reported that the purge solution was changed to sodium bicarbonate in the 5% dextrose in water after diagnosis of subarachnoid hemorrhage.An impella cp was inserted via the right femoral artery in a 74-year-old male presenting with acute myocardial infarction (ami) and cardiogenic shock (cgs).The patient¿s comorbidities were unspecified, however, the patient required multiple vasopressors, inotropic support, and mechanical circulatory support (mcs), including an intra-aortic balloon pump (iabp) and extracorporeal mechanical circulation (ecmo).The patient was noted to be in scai stage d shock before initiation of impella cp support.It was reported that endovascular treatment was necessary prior to insertion of impella cp device due to "poor vascular characteristics of the lower extremities." it was also reported that the impella cp device was inserted through a 16f dry seal sheath.At the time of device placement, a slight difference in pupillary reflex between the left and right eyes was noted.6 days after impella insertion, a computed tomography (ct) scan of the brain was performed in response to the patient having a sudden drop in blood pressure.The scan revealed a subarachnoid hemorrhage.The impella cp device functioned as intended with a performance level of p-7 with flows at 3.0 liters per minute and purge solution of 5% dextrose in water with 20 units/ml of heparin added and no device-related issues were identified that impacted performance or patient management.Bleeding is a known risk associated with large-bore arterial access and anticoagulation in critically ill patients.After 7 days of support, the impella cp device was removed, as mechanical circulatory support was deemed no longer necessary based on improved cardiac function.The patient survived at explant.

• 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 dr.; danvers, MA 01923 ; 7814934967
• MDR Report Key: 25390724
• Report Number: 1220648-2026-08459
• Device Sequence Number: 10700065
• Product Code: OZD
• UDI-Device Identifier: 00813502011371
• UDI-Public: (01)00813502011371(17)271111(10)2027825161
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/04/2026

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 0048-0024-JP
• Device Lot Number: 2027825161
• 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: 05/28/2026
• Supplement Date Received by Manufacturer: 06/04/2026
• Initial Report FDA Received Date: 06/04/2026
• Supplement Report FDA Received Date: 06/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/16/2026
• 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
• Concomitant Medical Products and Therapy/Usage Dates: EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO); INTRA-AORTIC BALLOON PUMP (IABP)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 74 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian