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	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemolysis (1886)
Date of Event	09/17/2026
Type of Reportable Event	Death
Event or Problem Description
Clinical narrative updated 2026-9-25: since the original reporting and clinical review, additional information regarding patient outcome has been received.The previously reported hemolysis did not resolve despite ongoing support and management.The patient remained on impella support for more than 3 days following onset of the hemolysis.At the time of the patient's clinical deterioration, the impella device continued to function as intended at performance level p-4, providing 2.4 l/min of flow with 5% dextrose in water and meylon/sodium bicarbonate purge solution.No device malfunction, interruption in support, or loss of pump performance was reported.Subsequently, the patient expired while on support.Although the device continued to operate as expected, the unresolved hemolysis persisted until the time of death and there was prior thoracic bleeding which contributed to the patient's clinical state.The contribution of the impella support to the patient's outcome cannot be excluded, despite the absence of any identified device malfunction and continued delivery of expected hemodynamic support parameters.Prior clinical narrative: impella cp smartassist was inserted via femoral artery access of undocumented side in a male patient of undocumented age presenting with acute myocardial infarction and cardiogenic shock.The patient's comorbidity was prior cardiopulmonary resuscitation (cpr).The patient's clinical condition prior to initiation of support was society for cardiovascular angiography and interventions (scai) shock stage c.Stage c patients present with hypoperfusion, are generally hypotensive, and require intervention beyond volume resuscitation.Prior to impella insertion, the patient was supported with inotropes, vasopressors, and respiratory support.The impella cp smartassist was inserted following return of spontaneous circulation (rosc).Prior to device insertion, the patient underwent cardiac massage and was noted to have intrathoracic bleeding, which was treated with placement of a drainage catheter.During support, the medical team observed hematuria and suspected hemolysis.To manage, the patient received transfusions of red blood cells and fresh frozen plasma.The quantity of blood products administered was not reported.Information regarding pump position and anticoagulation management was not provided, no activated clotting time (act) values before or during support were available for review.While on support, the device functioned as expected at performance level p-4 with reported flow of 2.4 l/min utilizing 5% dextrose in water with sodium bicarbonate purge solution.At the time of reporting, the impella cp smartassist remained in use and support was ongoing.No additional information regarding the reported hematuria, hemolysis, laboratory findings, pump position, or further interventions had been provided.The reported hemolysis is considered multifactorial and may be associated with the patient's critical clinical condition and the use of mechanical circulatory support, which is recognized to increase red blood cell shear stress.Due to limited clinical information, including unavailable anticoagulation parameters, absence of act values, undocumented pump position, and limited information regarding the patient's underlying medical history and comorbidities, the contribution of these factors cannot be fully assessed.The patient remained on impella support at the time of reporting.
Event or Problem Description
Clinical narrative updated 2026-10-6: since prior review the medical center has relayed clinical details regarding the patient outcome.It was reported that the resolution of the hemolysis prior to the death was not confirmed.The death occurred after the do not resuscitate decision was made due to brain damage.The cause of the neurological damage was not reported.Prior clinical narrative updated 2026-9-25: since the original reporting and clinical review, additional information regarding patient outcome has been received.The previously reported hemolysis did not resolve despite ongoing support and management.The patient remained on impella support for more than 3 days following onset of the hemolysis.At the time of the patient's clinical deterioration, the impella device continued to function as intended at performance level p-4, providing 2.4 l/min of flow with 5% dextrose in water and meylon/sodium bicarbonate purge solution.No device malfunction, interruption in support, or loss of pump performance was reported.Subsequently, the patient expired while on support.Although the device continued to operate as expected, the unresolved hemolysis persisted until the time of death and there was prior thoracic bleeding which contributed to the patient's clinical state.The contribution of the impella support to the patient's outcome cannot be excluded, despite the absence of any identified device malfunction and continued delivery of expected hemodynamic support parameters.Prior clinical narrative: impella cp smartassist was inserted via femoral artery access of undocumented side in a male patient of undocumented age presenting with acute myocardial infarction and cardiogenic shock.The patient's comorbidity was prior cardiopulmonary resuscitation (cpr).The patient's clinical condition prior to initiation of support was society for cardiovascular angiography and interventions (scai) shock stage c.Stage c patients present with hypoperfusion, are generally hypotensive, and require intervention beyond volume resuscitation.Prior to impella insertion, the patient was supported with inotropes, vasopressors, and respiratory support.The impella cp smartassist was inserted following return of spontaneous circulation (rosc).Prior to device insertion, the patient underwent cardiac massage and was noted to have intrathoracic bleeding, which was treated with placement of a drainage catheter.During support, the medical team observed hematuria and suspected hemolysis.To manage, the patient received transfusions of red blood cells and fresh frozen plasma.The quantity of blood products administered was not reported.Information regarding pump position and anticoagulation management was not provided, no activated clotting time (act) values before or during support were available for review.While on support, the device functioned as expected at performance level p-4 with reported flow of 2.4 l/min utilizing 5% dextrose in water with sodium bicarbonate purge solution.At the time of reporting, the impella cp smartassist remained in use and support was ongoing.No additional information regarding the reported hematuria, hemolysis, laboratory findings, pump position, or further interventions had been provided.The reported hemolysis is considered multifactorial and may be associated with the patient's critical clinical condition and the use of mechanical circulatory support, which is recognized to increase red blood cell shear stress.Due to limited clinical information, including unavailable anticoagulation parameters, absence of act values, undocumented pump position, and limited information regarding the patient's underlying medical history and comorbidities, the contribution of these factors cannot be fully assessed.The patient remained on impella support at the time of reporting.
Additional Manufacturer Narrative
A4 weight is unknown 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
Additional information was added to the b5 narrative.B2 date of death updated.

• 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)493-4967
• MDR Report Key: 50930886
• Report Number: 1220648-2026-13449
• Device Sequence Number: 9498602
• Product Code: OZD
• UDI-Device Identifier: 00813502011371
• 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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 0048-0024-JP
• Device Lot Number: 2027919003
• 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: 09/18/2026
• Initial Report FDA Received Date: 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/15/2026
• 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: Required Intervention; Death
• Patient Sex: Male
• Patient Race: Asian