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	Device Sensing Problem (2917); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Stroke/CVA (1770)
Date of Event	07/18/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Impella cp was inserted percutaneously via right femoral artery access site in an 73-year-old female patient presenting with high-risk percutaneous coronary intervention (hrpci).The patient¿s comorbidities included known coronary artery disease (cad) and diabetes mellitus.The patient¿s clinical state prior to initiation of support was society for cardiovascular angiography and interventions (scai) shock stage c.The patient was medically supported by inotropes, vasopressors.During support, the ao placement signal was observed at 98/70 mmhg and suddenly increased to 223/99 mmhg with a corresponding left ventricular placement signal increase to 235/38 mmhg.No changes were noted in pump performance, motor current, purge flow, purge pressure, or flow rate, which remained at 3.3 l/min at performance(p) p8.The clinical support center (csc) was contacted and recommended echocardiographic evaluation to confirm device position and indicated suspicion of an optical sensor failure.Subsequently, the patient developed acute right-sided weakness and slurred speech, prompting a stroke alert.Neurological evaluation documented an national institutes of health (nih) stroke scale score of 9 (classified as a moderate stroke) with diffuse but right-sided predominant weakness and dysarthria.Computed tomography of the head was negative for hemorrhage, while ct angiography demonstrated multivessel stenosis without large vessel occlusion.The treating team reported the event appeared embolic in nature and most likely cardioembolic in the setting of non-st segment elevation myocardial infarction (nstemi), with possible infarction of the left pyramidal tract pending mri evaluation.The patient remained on maximum medical therapy including heparin, aspirin, and ticagrelor.Pump position was subsequently confirmed by echocardiography, and no device replacement or removal due to the reported signal issue was required.The patient was successfully weaned from support, the device was explanted without complication, and the patient survived.A causal relationship between the impella device and the patient¿s stroke could not be dissociated based on the information provided.
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.

• 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 ; +1(781)493-4967
• MDR Report Key: 50099145
• Report Number: 1220648-2026-11104
• Device Sequence Number: 10006020
• Product Code: OZD
• UDI-Device Identifier: 00813502011876
• UDI-Public: (01)00813502011876(17)260930(10)2025599084
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/31/2026

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 Expiration Date: 09/30/2026
• Device Catalogue Number: 0048-0045
• Device Lot Number: 2025599084
• 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: 07/18/2026
• Initial Report FDA Received Date: 07/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/02/2024
• 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: 73 YR
• Patient Sex: Female
• Patient Weight: 165 LB
• Patient Race: White