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

Catalog Number	0052-3005
Medical Device Problem Codes	Difficult to Remove (1528); Difficult to Advance (2920); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Cardiac Perforation (2513)
Date of Event	03/31/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Clinical narrative: an impella cp was inserted via the femoral artery to support the 85-year-old male patient who had been admitted in with known coronary artery disease and a plan for a protected percutaneous coronary intervention (pci).The patient's underlying medical history was not shared.The team placed the cp into the left ventricle via the.018 guidewire as standard practice but, had difficulty removing the wire.The team had a "stuck" feeling.The team did proceed with the support but, found there was suction and low flows despite all standard troubleshooting by giving volume.Upon investigation by the physician the team observed there was a perforation of the left ventricle.The team emergently repaired the ventricle and replaced the aortic valve.The team relayed that the team had some difficulty crossing the valve, but beyond that gave no details on how/when the perforation occurred.The patient survived the unplanned surgery and pump explant.
Additional Manufacturer Narrative
This is one of two related reports.This report represent the guide wire and another report was submitted to represent the pump.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.
Additional Manufacturer Narrative
Updated information: h6 med dev prob code added a01.
Additional Manufacturer Narrative
H6: updated codes based on the results of the investigation.H11: updated based on the results of the investigation.Investigation summary: cardiac perforation/patient-device interaction: the cause of cardiac perforation/patient-device interaction was unable to be determined as limited clinical details were provided and no product was returned for review.Difficult/unable to remove through other device: the cause of difficult/unable to remove through other device was unable to be determined as limited clinical details were provided and no product was returned for review.Difficult to advance: the cause of difficult to advance was unable to be determined as limited clinical details were provided and no product was returned for review.

• 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 drive; danvers, MA 01923 ; 7814934967
• MDR Report Key: 24818588
• Report Number: 1220648-2026-06529
• Device Sequence Number: 20336379
• Product Code: OZD
• UDI-Device Identifier: 04260113630303
• UDI-Public: (01)04260113630303(11)250305(10)9464325
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/22/2026

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: 0052-3005
• Device Lot Number: 9464325
• 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: 03/31/2026
• Supplement Date Received by Manufacturer: 04/15/2026; 05/26/2026
• Initial Report FDA Received Date: 04/08/2026
• Supplement Report FDA Received Date: 04/22/2026; 05/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/05/2025
• 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: 85 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White