MAUDE Adverse Event Report: ABIOMED, INC. - 1220648 IMPELLA; INTRODUCER, CATHETER (INTRODUCER)

Catalog Number	2000342
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	04/08/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
An impella rp flex device was inserted via the right femoral vein in a 51-year-old male patient with a history of diabetes mellitus and renal insufficiency.The patient¿s clinical state prior to initiation of support was identified as scai shock stage d.During the procedure, bleeding was noted from the hemostatic valve of the rp flex peel-away sheath, requiring the opening of a new insertion kit.The team was called to discuss low flows, with elevated placement signal (ps) and low anticoagulation levels.Heparin was started earlier.It was discussed that flows may be falsely low due to elevated ps.No hemolysis changes were observed, but monitoring for hemolysis was ongoing.On rounds, ps remained elevated (137/84[103]) and flows were much lower than expected (2.1/0.5 [1.5] at p8).Motor current (mc) was 390/342 (365), consistent with the selected p level of p8.Heparin initiation was delayed.Possible clot, sensor drift, or need for device replacement were discussed after echocardiography showed a decompressed right ventricle, suggesting actual flows were higher than calculated.Physicians were consulted about possible clot in the device, and further echo revealed a severely dilated right ventricle and ivc, with color doppler confirming flow at the outflow.The team decided to leave the flex in place while considering escalation to a cp 5.5 for higher mechanical support.Trend screen at 24 hours showed a spike in motor current and placement signal with an immediate drop in flows.Coagulation was found to be subtherapeutic.Replacement of the rp flex was discussed, but the physician declined due to the patient¿s status.The patient expired on support.Bleeding, thrombosis, and hemolysis may occur due to anticoagulation and purge requirements associated with impella support, and can be attributed to patient-specific factors such as critical illness, delayed anticoagulation and low-flow states during mechanical circulatory support.The device will be conservatively reported for death; however, the death is most likely attributed to the patient's underlying critical clinical condition as the patient presented in scai shock stage d.
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
Updated clinical narrative: an impella rp flex device was inserted via the right femoral vein in a 51-year-old male patient with a history of diabetes mellitus and renal insufficiency.The patient¿s clinical state prior to initiation of support was identified as scai shock stage¿d.During the procedure, bleeding was noted from the hemostatic valve of the rp flex peel-away sheath, requiring the opening of a new insertion kit.There was no blood product given due to the hemostatic valve issue.The team was called to discuss low flows, with elevated placement signal (ps) and low anticoagulation levels.Heparin was started earlier.It was discussed that flows may be falsely low due to elevated ps.No hemolysis changes were reported to be observed, but monitoring for hemolysis was ongoing.It was later reported that the labs were hemolyzed according to the rn.On rounds, ps remained elevated (137/84[103]) and flows were much lower than expected (2.1/0.5 [1.5] at p8).Motor current (mc) was 390/342 (365), consistent with the selected p level of p8.Heparin initiation was delayed.Possible clot, sensor drift, or need for device replacement were discussed after echocardiography showed a decompressed right ventricle, suggesting actual flows were higher than calculated.Physicians were consulted about possible clot in the device, and further echo revealed a severely dilated right ventricle and ivc, with color doppler confirming flow at the outflow.The team decided to leave the flex in place while considering escalation to a cp 5.5 for higher mechanical support.Trend screen at 24 hours showed a spike in motor current and placement signal with an immediate drop in flows.Coagulation was found to be subtherapeutic.During the night critical care doc made the decision to stop heparin due to a high inr.Replacement of the rp flex was discussed, but the physician declined due to the patient¿s status.The patient expired on support.Bleeding, thrombosis, and hemolysis may occur due to anticoagulation and purge requirements associated with impella support, and can be attributed to patient-specific factors such as critical illness, delayed anticoagulation and low-flow states during mechanical circulatory support.The device will be conservatively reported for death; however, the death is most likely attributed to the patient's underlying critical clinical condition as the patient presented in scai shock stage d.
Additional Manufacturer Narrative
Updated information: b5 clinical narrative updated.D4 catalog number updated.
Additional Manufacturer Narrative
Fluid leak/ major bleed: the cause of the bleed was not determined due to lack of clinical details, no product returned for analysis.

• Brand Name: IMPELLA
• Common Device Name: INTRODUCER, CATHETER (INTRODUCER)
• 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: 24884547
• Report Number: 1220648-2026-06806
• Device Sequence Number: 16034902
• Product Code: DYB
• UDI-Device Identifier: 00813502010411
• UDI-Public: (01)00813502010411(17)270831(10)S9241388
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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
• Report Date (Section B): 05/04/2026

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: 2000342
• Device Lot Number: S9241388
• 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: 04/08/2026
• Supplement Date Received by Manufacturer: 04/23/2026; 06/04/2026
• Initial Report FDA Received Date: 04/15/2026
• Supplement Report FDA Received Date: 05/04/2026; 06/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/11/2024
• 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: Male
• Patient Weight: 127 KG
• Patient Race: Black Or African American