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

Catalog Number	0052-3005
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/13/2026
Type of Reportable Event	Malfunction
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 left femoral artery in a 74-year-old male patient for acute myocardial infarction complicated by cardiogenic shock (ami/cgs), presenting in society for cardiovascular angiography and interventions (scai) stage e shock.During implantation, difficulty crossing a transcatheter aortic valve replacement (tavr) valve with the pigtail and 0.018-inch guidewire was reported.Despite this, the impella cp was successfully advanced over the wire without issue, and the pump initially functioned without concerns.During a subsequent peel-away sheath exchange performed by the physician and scrub team, the pump was observed to be pulled backwards.Attempts to re-advance the device into the left ventricle (lv) were unsuccessful due to a kink identified in the cannula just below the motor housing.At that time, flows were reduced to approximately 2.1 l/min.Based on these findings, the clinical team elected to remove the affected impella cp and replace it with a new impella cp.No adverse events were reported with the second impella cp.The patient ultimately expired.The survival outcome was death, which is being conservatively reported and coded to the first impella cp.However, based on the available clinical information, the death is more likely attributable to the patient¿s underlying critical condition, including severe ami/cgs and scai stage e cardiogenic shock.
Additional Manufacturer Narrative
E4 was inadvertently omitted on the initial manufacturer device report.
Additional Manufacturer Narrative
Added d3 manufacturer fax was omitted during initial report.H6 investigation: type, findings, and conclusion codes and h6 component codes were updated accordingly based on the completed investigation.The cause of the guidewire delivery issue was most likely related to patient condition due to presence of tavr causing interaction with guidewire.

• 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): ABIOMED, INC.; 22 cherry hill drive; danvers MA 01923
• Manufacturer Contact: derek sammarco ; 22 cherry hill dr.; danvers, MA 01923 ; 7814934967
• MDR Report Key: 24889791
• Report Number: 1220648-2026-06843
• Device Sequence Number: 18765460
• Product Code: OZD
• UDI-Device Identifier: 04260113630303
• UDI-Public: (01)04260113630303(17)280430(10)9464337
• Combination Product (Y/N): N
• Initial Reporter State: NH
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/15/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 0052-3005
• Device Lot Number: 9464337
• 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: 04/13/2026
• Supplement Date Received by Manufacturer: 05/04/2026; 06/10/2026
• Initial Report FDA Received Date: 04/15/2026
• Supplement Report FDA Received Date: 05/08/2026; 06/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/19/2025
• 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
• Patient Age: 74 YR
• Patient Sex: Male
• Patient Weight: 90 KG
• Patient Race: White