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	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Ischemia (1942)
Date of Event	07/28/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Clinical narrative impella cp was inserted via left femoral artery in a 80-year-old male patient presenting with acute myocardial infarction and cardiogenic shock.The patient¿s comorbidities were known peripheral arterial disease at the superficial femoral artery.The patient¿s clinical state prior to initiation of support was society for cardiovascular angiography and interventions (scai) shock stage e.Prior to the impella cp placement the patient was supported by extra corporeal membrane oxygenation (ecmo).While on support the the device functioned as expected, performance level p-8 with 3.1l/min flow with 5% dextrose in water with sodium bicarbonate in the purge solution.While on support the team did add inotropes and vasopressors due to patient condition.The impella accessed limb showed signs of ischemia.The leg had become pale and discolored.This prompted the explant of the pump after just 1 day of support.The physician placed a new second impella cp at the right subclavian artery and performed endovascular thrombectomy (evt) to restore limb flow.The patient's limb ischemia occurred after the pump delivery to the femoral artery which was noted to be narrow.The underlying peripheral disease may have contributed.Additionally, limb ischemia has an increased risk of occurrence in patients in scai shock stage c,d, and e since there is potential for the patient to concurrently be on vasopressors for medical treatment.
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 (Section G): Danvers
• Manufacturer Contact: derek sammarco ; 22 cherry hill drive; danvers, MA 01923 ; +1(781)739-0590
• MDR Report Key: 50122855
• Report Number: 1220648-2026-11217
• Device Sequence Number: 21464532
• Product Code: OZD
• UDI-Device Identifier: 00813502011609
• UDI-Public: (01)00813502011609(17)271231(10)2027858043
• Combination Product (Y/N): N
• 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): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,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: 0048-0024-JP
• Device Lot Number: 2027858043
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/28/2026
• Supplement Date Received by Manufacturer: 09/04/2026
• Initial Report FDA Received Date: 08/03/2026
• Supplement Report FDA Received Date: 09/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/09/2026
• 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: Other
• Patient Age: 80 YR
• Patient Sex: Male
• Patient Race: Asian