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

Catalog Number	2000342
Medical Device Problem Codes	Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Thrombosis/Thrombus (4440)
Date of Event	03/26/2026
Type of Reportable Event	Serious Injury
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
It was reported that a patient implanted with an impella rp experienced access site oozing.The physician decided to leave the peel away sheath in place.The patient was in stable condition.
Additional Manufacturer Narrative
Additional information received for d6 explant.
Event or Problem Description
Additional information was received indicating that the impella device was explanted.
Additional Manufacturer Narrative
B5 clinical narrative updated.Section d4 catalog number was corrected.
Event or Problem Description
Clinical narrative: an impella rp flex was inserted via the axillary/subclavian vein, with the 23 fr introducer sheath, to support the 70 year old male patient who had been admitted in with indication of acute myocardial infarction and cardiogenic shock, presenting in scai stage e shock.The underlying medical history was not shared.Prior to the rp flex placement the team did have the patient on support with inotropes, vasopressors, and a vent for respiratory needs.The medical team did not follow the instructions for use (ifu), and did not remove the 23fr sheath, but rather retained it within the vein.The physician was aware of this being against the ifu.The day after implant there was minor bleeding at the access site observed.The hemoglobin remained stable and so no infusion of blood product was done.The pump remains on for support despite this blood loss around the sheath.Anticoagulation necessary for the pump placement and support can contribute to bleeding.
Additional Manufacturer Narrative
Access site adverse event / minor bleed / use against labeling: the cause of the issue was most likely related to reasonably foreseeable misuse of the device, as the physician elected not to remove the peel-away sheath.As per the ifu, the peel-away sheath should be removed prior to patient transfer to prevent potential failure.Thrombosis: the cause of the injury was not determined due to insufficient clinical details.
Event or Problem Description
An impella rp flex device was inserted via the axillary/subclavian vein using a 23 fr introducer sheath to support a 70-year-old male patient admitted with acute myocardial infarction complicated by cardiogenic shock, presenting in scai shock stage e.The patient¿s underlying medical history was not provided.Prior to impella rp flex placement, the patient was supported with inotropes, vasopressors, and mechanical ventilation for respiratory support.The medical team elected not to remove the 23 fr peel-away sheath as specified in the instructions for use (ifu) and instead retained the sheath within the vein.The physician was aware that this approach was outside ifu recommendations.On the day following implantation, minor bleeding was observed at the access site.After a dressing change, no further bleeding was noted.Hemoglobin levels remained stable, and no blood product transfusions were required.The provider acknowledged and accepted the potential risks associated with leaving the peel-away sheath in place.Upon subsequent removal of the sheath, the patient was found to have a deep vein thrombosis (dvt) in the left subclavian vein.The medical care team planned to initiate dvt management per protocol.The patient survived to explant.The reported thrombosis may be related to prolonged venous instrumentation and retained large-bore sheath placement in the setting of critical illness and cardiogenic shock.
Additional Manufacturer Narrative
B1 and h1: added serious injury.B5: added updated clinical review.H6: added e0514.Additional information: the following information was received: the bleeding was mild oozing from initial placement, once dressing was changed, patient no longer experience any bleeding.Unfortunately, the introducer was discarded by staff.The sheath was inspected prior to use and no issues were noted.

• Brand Name: IMPELLA
• Common Device Name: INTRODUCER, CATHETER (INTRODUCER)
• Manufacturer (Section D): ABIOMED, INC. - 1220648; 22 cherry hill drive; danvers MA 01923
• Manufacturer (Section G): ABIOMED, INC.; 22 cherry hill drive; danvers MA 01923
• Manufacturer Contact: derek sammarco ; 22 cherry hill drive; danvers, MA 01923 ; 7814934967
• MDR Report Key: 24775504
• Report Number: 1220648-2026-06335
• Device Sequence Number: 6134196
• Product Code: OZD
• UDI-Device Identifier: 00813502012910
• UDI-Public: (01)00813502012910(17)271130(10)S9512215
• 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,Followup,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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 2000342
• Device Lot Number: S9512215
• 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: 03/26/2026
• Supplement Date Received by Manufacturer: 04/04/2026; 04/02/2026; 04/14/2026; 05/21/2026
• Initial Report FDA Received Date: 04/03/2026
• Supplement Report FDA Received Date: 04/07/2026; 04/08/2026; 04/17/2026; 05/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/03/2025
• 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
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 70 KG
• Patient Ethnicity: Hispanic
• Patient Race: White