MAUDE Adverse Event Report: Abiomed, Inc. - 1220648 Impella; Temporary Non-Roller Type Left Heart Support Blood Pump

Catalog Number	1000100
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Stroke/CVA (1770); Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	09/02/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Product/patient demographics/indication/baseline presentation: an impella 5.5 with smartassist was inserted via the right axillary artery in a 47 year-old male patient with cardiomyopathy presenting in society for cardiovascular angiography and interventions (scai) shock stage c.Scai stage c is defined as clinical evidence of cardiogenic shock that initially requires pharmacological or mechanical circulatory support.Prior to initiation of support, the patient was receiving vasopressor and inotropic therapy.The patient's medical history was not reported.The patient measured 185 cm in height and weighed 90 kg.Device course & treatment: on day 5 of support, a small hematoma was reported at the right axillary impella 5.5 insertion site.No suction alarms, interruption of support, or blood product replacement were reported.The hematoma resolved without intervention and no additional treatment was required.After 24 days of support, beyond the 14-day duration per the instructions for use (ifu), the patient underwent heart transplantation with explant of the impella 5.5 and peripheral va-ecmo.Peripheral va-ecmo had been initiated three days prior to transplant.Ecmo is the primary hemodynamic support device with the impella being utilized for left ventricular venting.No biomaterial was observed in the device upon explant.Following arrival to the intensive care unit after the transplant procedure and upon awakening, the patient was noted to have left-sided weakness.A code stroke was initiated and computed tomography demonstrated an infarct that rapidly converted to a hemorrhagic stroke.The patient subsequently underwent craniotomy performed by neurosurgery.The outcome was reported a survival post craniotomy.Additional factors: peripheral va-ecmo was being utilized in addition to impella support around the time of the reported stroke.No biomaterial was observed in the outflow at explant.Anticoagulation was monitored using partial thromboplastin time (ptt), which was reported at 73 seconds on the day prior to the event.However, it is uncertain how the reported ptt correlates with abiomed's recommended activated clotting time (act) range of 160 to 180 seconds during support.Pump metrics reported the day prior to the event demonstrated that the impella 5.5 was functioning as intended at performance level 5 with expected flows of approximately 3.3 l/min while utilizing a purge solution containing 25 meq/l sodium bicarbonate.Device contribution: the reported hematoma cannot be ruled out as associated with the vascular access site utilized for impella 5.5 support.The reported hemorrhagic stroke cannot be dissociated from impella 5.5 support, as it occurred following device explant.However, contributing factors are, prolonged impella support, concurrent peripheral va-ecmo support and, heart transplantation.
Event or Problem Description
Updated clinical narrative: (additional information received by the field representative).Following the reported hemorrhagic stroke, additional information indicated the patient developed disseminated intravascular coagulation (dic) with diffuse bleeding from multiple sites.The family subsequently elected to withdraw care, and the patient expired.However, the timing of death relative to the hemorrhagic stroke was not reported.Based on the available information, the reported hemorrhagic stroke cannot be ruled out as being associated with impella 5.5 support, as it occurred following explant of the device.Additional contributing factors include multiple mechanical circulatory devices utilized, heart transplantation procedure, and the reported development of dic with diffuse bleeding.Prior clinical narrative: product/patient demographics/indication/baseline presentation: an impella 5.5 with smartassist was inserted via the right axillary artery in a 47 year-old male patient measuring 185 cm in height and weighed 90 kg with cardiomyopathy presenting in society for cardiovascular angiography and interventions (scai) shock stage c.Scai stage c is defined as clinical evidence of cardiogenic shock that initially requires pharmacological or mechanical circulatory support.Prior to initiation of support, the patient was receiving vasopressor and inotropic therapy.The patient's medical history was not reported.The patient measured 185 cm in height and weighed 90 kg.Device course & treatment: on day 5 of support, a small hematoma was reported at the right axillary impella 5.5 insertion site.No suction alarms, interruption of support, or blood product replacement were reported.The hematoma resolved without intervention and no additional treatment was required.After 24 days of support, beyond the 14-day duration per the instructions for use (ifu), the patient underwent heart transplantation with explant of the impella 5.5 and peripheral va-ecmo.Peripheral va-ecmo had been initiated three days prior to transplant.Ecmo is the primary hemodynamic support device with the impella being utilized for left ventricular venting.No biomaterial was observed in the device upon explant.Following arrival to the intensive care unit after the transplant procedure and upon awakening, the patient was noted to have left-sided weakness.A code stroke was initiated and computed tomography demonstrated an infarct that rapidly converted to a hemorrhagic stroke.The patient subsequently underwent craniotomy performed by neurosurgery.The outcome was reported a survival post craniotomy.Additional factors: peripheral va-ecmo was being utilized in addition to impella support around the time of the reported stroke.No biomaterial was observed in the outflow at explant.Anticoagulation was monitored using partial thromboplastin time (ptt), which was reported at 73 seconds on the day prior to the event.However, it is uncertain how the reported ptt correlates with abiomed's recommended activated clotting time (act) range of 160 to 180 seconds during support.Pump metrics reported the day prior to the event demonstrated that the impella 5.5 was functioning as intended at performance level 5 with expected flows of approximately 3.3 l/min while utilizing a purge solution containing 25 meq/l sodium bicarbonate.Device contribution: the reported hematoma cannot be ruled out as associated with the vascular access site utilized for impella 5.5 support.The reported hemorrhagic stroke cannot be dissociated from impella 5.5 support, as it occurred following device explant.However, contributing factors are, prolonged impella support, concurrent peripheral va-ecmo support and, heart transplantation.
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.
Additional Manufacturer Narrative
Updated information: b2 selected death and added date of death.B5 narrative updated.H1 changed to death.

• 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 ; +1(781)493-4967
• MDR Report Key: 50933221
• Report Number: 1220648-2026-13470
• Device Sequence Number: 13443104
• Product Code: OZD
• UDI-Device Identifier: 00813502012828
• UDI-Public: (01)00813502012828(17)280531(10)2027926594
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/01/2026

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 1000100
• Device Lot Number: 2027926594
• 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: 09/03/2026
• Supplement Date Received by Manufacturer: 09/30/2026
• Initial Report FDA Received Date: 09/29/2026
• Supplement Report FDA Received Date: 10/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/29/2026
• 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: Death; Required Intervention
• Patient Age: 47 YR
• Patient Sex: Male
• Patient Weight: 198 LB
• Patient Race: White