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	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Perforation of Vessels (2135)
Date of Event	09/10/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Impella cp smartassist was inserted via left femoral artery access in a 33-year-old male patient presenting with idiopathic cardiomyopathy.The patient's comorbidities and society for cardiovascular angiography and interventions (scai) shock stage prior to initiation of support were not documented.The clinical course was identified through published literature; therefore, limited information regarding the duration of support and procedural details was available.The publication reported that the patient received heparin anticoagulation with an activated clotting time (act) of 160 seconds prior to the procedure and maintained act values between 160 and 200 seconds during support.Following completion of treatment and impella cp smartassist explant, bleeding was observed at the femoral access site.Evaluation identified a femoral artery dissection with an associated vessel wall defect.The treating physician performed surgical intervention, including arterial clamping and repair of the vessel defect using a 6-0 nesplen patch.Following completion of the repair, clamps were released and hemostasis was achieved.Reported operative time was 15 minutes with an estimated blood loss of 150 cc.The postoperative course was uneventful.The patient was extubated the following day, and contrast-enhanced computed tomography performed on postoperative day 7 demonstrated no abnormalities at the repair site.Sutures were removed on postoperative day 8, and the patient continued medical management without reported sequelae.No additional clinical, hemodynamic, or device performance information was provided within the publication.The femoral artery dissection and bleeding were observed following device explant and required surgical repair.Based on the available information, the contribution of access technique, anticoagulation management, underlying vascular anatomy, or other patient-specific factors cannot be determined.
Additional Manufacturer Narrative
Product complaint # (b)(4).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 Contact: derek sammarco ; 22 cherry hill drive; danvers, MA 01923 ; +1(781)493-4967
• MDR Report Key: 50866959
• Report Number: 1220648-2026-13237
• Device Sequence Number: 9425383
• Product Code: OZD
• UDI-Device Identifier: 00813502011371
• UDI-Public: (01)00813502011371(11)250614(17)270430(10)2026703779
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P140003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Literature,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial

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: 2026703779
• 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: 09/09/2026
• Initial Report FDA Received Date: 09/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/14/2025
• 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: Required Intervention
• Patient Age: 33 YR
• Patient Sex: Male
• Patient Weight: 143 LB