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	Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Ischemia (1942); Ventricular Fibrillation (2130)
Date of Event	03/04/2026
Type of Reportable Event	Serious Injury
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
Clinical review/rationale: an impella cp was inserted via the femoral artery to support the 51-year-old female patient who had been admitted in with coronary artery disease, and a plan for a protected percutaneous coronary intervention (pci).The introducer was not the abiomed provided, but rather access was made with a cook 14fr introducer sheath.The patient's underlying medical history was not shared.The.018 guidewire was inserted to the left ventricle and the patient suffered from ventricular fibrillation.Cpr was begun and the cp pump was advanced to the ventricle.The cpr was ongoing for 55 minutes and they added extra corporeal membrane oxygenation (ecmo) and proceeded with the angioplasty of the 2 coronary arteries.The patient was given 2 units of blood.The leg accessed by the cp pump was ischemic and they used the ecmo circuit to allow for leg reperfusion.Of note the legs were bilaterally showing signs of ischemia, inclusive of pallor/color change.After 3 days the pump was explanted and escalated to the axillary accessed 5.5 pump.The patient survived the harms and of note the cook sheath and ecmo could have caused/contributed to the harm.Ischemia may be influenced by patient-specific factors such as severe peripheral vascular disease, underlying critical illness, hemodynamic instability, and vascular access characteristics.
Additional Manufacturer Narrative
Corrected information was provided in d3, g1 (manufacturer fax).Upon review, it was identified that it was inadvertently omitted from the initial report.Corrected information was provided in e3 (initial reporter occupation).Upon review, it was identified that it was inadvertently submitted in error in the initial report.H6: updated codes based on the results of the investigation.H11: updated based on the results of the investigation.The cause of the injury was unable to be determined due to insufficient clinical details.The cause of the patient device interaction was not determined due to insufficient clinical details.
Additional Manufacturer Narrative
B5.Additional event description added d1.Brand name updated h6.Health effect - impact code added according to updated clinical review.H6.Medical device problem code added according to updated clinical review.
Event or Problem Description
Additional clinical information reports an impella cp was inserted via the femoral artery to support the 51 year old female patient who had been admitted in with coronary artery disease, and a plan for a protected percutaneous coronary intervention (pci).The patient's underlying medical history was not shared.The.018 guidewire was inserted to the left ventricle and the patient suffered from ventricular fibrillation.Cpr was begun and the cp pump was advanced to the ventricle.The cpr was ongoing for 55 minutes and they added extra corporeal membrane oxygenation (ecmo) and proceeded with the angioplasty of the 2 coronary arteries.The patient was given 2 units of blood likely due to preexisting conditions.The legs were bilaterally showing signs of ischemia, inclusive of pallor/color change.Contributing factors listed were ecmo and use of a cook sheath.After 3 days the pump was explanted and escalated to the axillary accessed 5.5 pump.The patient survived.

• 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 ; 7814934967
• MDR Report Key: 24587300
• Report Number: 1220648-2026-05181
• Device Sequence Number: 14884178
• Product Code: OZD
• UDI-Device Identifier: 04260113630303
• UDI-Public: (01)04260113630303(17)271231(10)9464321
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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

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: 0052-3005
• Device Lot Number: 9464321
• 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: 03/04/2026
• Supplement Date Received by Manufacturer: 04/20/2026; 04/28/2026
• Initial Report FDA Received Date: 03/12/2026
• Supplement Report FDA Received Date: 04/24/2026; 04/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/03/2025
• 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: 51 YR
• Patient Sex: Female
• Patient Weight: 106 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White