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	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/21/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
An impella cp was implanted via the right femoral artery in a 70-year-old male patient for pre-operative ventricular support prior to a planned ventricular septal perforation (vsp) closure.Prior to impella support, the patient was classified as society for cardiovascular angiography and intervention (scai) stage b shock, indicating hemodynamic instability.The patient was receiving ventilatory support prior to implantation.The patient's past medical history was not reported.The impella cp provided hemodynamic support and functioned within expected operating parameters at p-5 with reported flows of approximately 2.6 l/min utilizing a d5w sodium bicarbonate purge solution.After approximately four days of support, an attempt was made to surgically remove the impella cp in the intensive care unit (icu); however, significant resistance was encountered during extraction.Fluoroscopic evaluation demonstrated that the pigtail tip remained stationary, raising concern for entanglement with an intracardiac structure.The patient was transferred to a hybrid operating room, where a second removal attempt under fluoroscopic guidance was performed; however, the device remained unable to be extracted.To identify the source of resistance and facilitate device removal, a thoracotomy was performed.Direct visualization through a left ventricular approach demonstrated that the impella pigtail was entrapped within the suture line of the ventricular septal perforation (vsp) patch repair.The entanglement was successfully released, the impella shaft was transected, and the device was removed through the groin.The chest was subsequently closed, concluding the procedure.No adverse clinical consequences were reported.The post-procedure outcome is survived at explant.
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 Contact: derek sammarco ; 22 cherry hill drive; danvers, MA 01923 ; +1(781)493-4967
• MDR Report Key: 50456035
• Report Number: 1220648-2026-12094
• Device Sequence Number: 10377208
• Product Code: OZD
• UDI-Device Identifier: 00813502011609
• UDI-Public: (01)00813502011609(17)280331(10)2027919001
• 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): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/26/2026

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 Catalogue Number: 0048-0024-JP
• Device Lot Number: 2027919001
• 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: 08/21/2026
• Initial Report FDA Received Date: 08/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/15/2026
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Race: Asian