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 Codes	Restricted Flow rate (1248); Malposition of Device (2616); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Low Blood Pressure/ Hypotension (1914); Mitral Valve Insufficiency/ Regurgitation (4451)
Date of Event	12/01/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Clinical narrative: an impella cp was inserted via the femoral artery, of undocumented side, to support the 75-year-old male patient admitted with known coronary artery disease and plan for the off-pump coronary artery bypass (opcab) surgery.The patient did present per documentation in society for cardiovascular angiography and interventions (scai) stage c shock at the time of pump insertion.The patient had a medical history inclusive of hypertension, dyslipidemia, chronic kidney disease, and heart disease.The impella cp supported the patient for 4 days in (b)(6) of 2024, and was successfully weaned and explanted.The team in japan published upon the support.The publication was discovered by a social media post in july 2026.The publication noted the impella cp was placed pre-operatively and supported for the opcab.While in the operating suite the pump became malpositioned deeper within the left ventricle.The positioning of the pump allowed for the mitral valve leaflet to be interacted with and the team noted new mitral valve regurgitation.After 90 minutes the patient condition deteriorated and the patient was noted to be hypotensive.The team made the decision to escalate care and extra corporeal membrane oxygenation (ecmo) was added.Once ecmo was added the impella cp acted as a ventricle ventilation for the primary support device, ecmo.The heart bypass surgery continued.At the conclusion of the opcab, the ecmo was explanted.The team further evaluated the impella pump position and the team saw there was no need for mitral valve surgery and repair.The pump was explanted after 4 days of support and on day 13 the patient was discharged from the intensive care unit.The mild jet observed from the mitral valve was still present, but did not need surgical intervention.The mitral valve regurgitation was not known to the abiomed team in japan in 2024 when the harm took place.Per the publication and medical team in japan, the use of the impella is useful to surgical patients however the change in pump position caused the impella to interfere with the posterior mitral valve leaflet and led to severe mitral regurgitation.
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 drive; danvers, MA 01923 ; +1(781)493-4967
• MDR Report Key: 50054905
• Report Number: 1220648-2026-10960
• Device Sequence Number: 15825397
• Product Code: OZD
• UDI-Device Identifier: 00813502011371
• UDI-Public: (01)00813502011371(17)260430(10)2025511538
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P140003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Literature,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: 04/30/2026
• Device Catalogue Number: 0048-0024-JP
• Device Lot Number: 2025511538
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/20/2026
• Supplement Date Received by Manufacturer: 07/28/2026
• Initial Report FDA Received Date: 07/28/2026
• Supplement Report FDA Received Date: 07/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/28/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ECMO
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Weight: 125 LB
• Patient Race: Asian