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 Codes	Restricted Flow rate (1248); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Thromboembolism (2654)
Date of Event	07/28/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Clinical narrative us: impella cp was inserted via left femoral artery in a 79-year-old male patient presenting with acute myocardial infarction and cardiogenic shock.The patient¿s comorbidities were not shared.The patient¿s clinical state prior to initiation of support was society for cardiovascular angiography and interventions (scai) shock stage was not noted, but after implant of the impella the scai shock stage is documented at stage c.The physician added extra corporeal membrane oxygenation (ecmo) to the impella cp support as during the coronary angioplasty there was slow flow when intervening upon the right coronary artery.The impella cp would vent the ventricle for the primary support ecmo.While on support the the device functions as expected, performance level p-3 with 1.9l/min flow with 5% dextrose in water with heparin in the purge solution.On the second day of support the pump flow rate had dropped to zero.Echocardiography and volume status assessments showed no abnormalities and positioning and motor waveforms appeared normal.As the patient was clinically improving the pump was weaned and explanted.The ecmo remained on to support the patient.At the impella cp explant there was an observation made of biomaterial near the pump's impeller.The operators questioned thrombus development.The patient's heparin had been temporarily discontinued due to an activated clotting time (act) earlier in the morning that had exceeded 200.There is an increased risk of biomaterial accumulation when anticoagulation is held due to the risk of the act falling below the recommended parameters of 160 seconds to 180 seconds.The patient survived the event and ecmo support continued.
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 dr.; danvers, MA 01923 ; +1(781)739-0590
• MDR Report Key: 50122705
• Report Number: 1220648-2026-11214
• Device Sequence Number: 17551916
• Product Code: OZD
• UDI-Device Identifier: 00813502011371
• UDI-Public: (01)00813502011371(17)280331(10)2027925756
• 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

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: 2027925756
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/03/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/28/2026
• Initial Report FDA Received Date: 08/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/26/2026
• 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
• Concomitant Medical Products and Therapy/Usage Dates: Extracorporeal membrane oxygenation
• Outcome Attributed to Adverse Event: Other
• Patient Age: 79 YR
• Patient Sex: Male
• Patient Race: Asian