MAUDE Adverse Event Report: ABIOMED, INC. - 1220648 IMPELLA; TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP

Model Number	RP FLEX W SMART ASSIST SET, US
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	02/19/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
An impella cp was inserted in a 65 year old male admitted for acute myocardial infarction with cardiogenic shock.The patient¿s comorbidities were unknown.The patient's clinical state prior to initiation of support was scai stage e.The patient was bridged to 5.5 for aortic valvuloplasty.On day 7 of 5.5 support, an attempt was made to escalate the patient to bipella support.An impella rp flex was attempted via right femoral vein.The device was unable to pass due to the patient's vasculature, which appeared to cause the wire to prolapse and possible dissection of the vein.It was reported a temporary pacer was also previously placed in that vessel.The rp flex implant was aborted.Vascular injury is a known potential adverse event of the impella rp flex per the instructions for use.The complainant has also reported that the device has since been discarded and that the patient's outcome was good.The devices were explanted monday 2/22 and the patient was downgraded out of the icu.
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
The suspect medical device was inadvertently misidentified in the initial report.Accordingly, the relevant fields in section d (suspect medical device), section g (all manufacturers), and section h (device manufacturers only) have been corrected, updated to accurately reflect the impella guidewire.Additional h6 health effect - clinical/impact and medical device problem coding was repopulated to ensure alignment with corrected complaint device.Note: h1.The type of reportable event (serious injury) and b1.Adverse event and b2.Outcomes attributed to the adverse event remain unchanged as previously reported.D6a implant date and d6b explant date should be disregarded as the suspect medical device has been corrected to the guidewire.

• 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 dr.; danvers, MA 01923 ; 7814934967
• MDR Report Key: 24483352
• Report Number: 1220648-2026-04327
• Device Sequence Number: 18810438
• Product Code: OZD
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P170011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/02/2026

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 Model Number: RP FLEX W SMART ASSIST SET, US
• Device Catalogue Number: 0052-3018
• Device Lot Number: 1928010
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/19/2026
• Supplement Date Received by Manufacturer: 04/20/2026; 09/29/2026
• Initial Report FDA Received Date: 03/02/2026
• Supplement Report FDA Received Date: 04/22/2026; 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/14/2024
• 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: 65 YR
• Patient Sex: Male
• Patient Weight: 114 LB
• Patient Race: Black Or African American