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

Catalog Number	0052-3006
Medical Device Problem Codes	Fluid/Blood Leak (1250); Nonstandard Device (1420); Appropriate Device Problem Term/Code Not Available (3191); Patient Device Interaction Problem (4001); Difficult or Delayed Separation (4044)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/06/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D6b, date of explant, has been added.
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 blood was leaking from the peel away sheath.No patient harm was reported.
Additional Manufacturer Narrative
D9: added the devices return information h6: per a review of the complaint file, omitted code e2403 and f26.Added codes e0506, f11, a27.
Additional Manufacturer Narrative
B5.Additional event description added.
Event or Problem Description
Additional information received reporting that there was leaking of blood from the peel away sheath.The surgeon claims it feels different.More stiff than in the past and the valve was more difficult to pop.
Additional Manufacturer Narrative
H6 medical device problem code were updated/corrected and repopulated accordingly.
Additional Manufacturer Narrative
H6: per a review of the complaint file, omitted code a27.Added codes a020102, a01 and a050401.
Additional Manufacturer Narrative
Per review code a150302 was added.
Additional Manufacturer Narrative
Device history review was completed and noted the introducer lot 2038749 passed all incoming inspection criteria.Defective component / difficulty separating introducer sheath cause was determined to be a supplier manufacturing defect since deformation and stretching was observed along the scoreline starting at the hub.Minor bleed / fluid leak / patient-device interaction: the cause of the bleed was unable to be determined since the device was returned split and unable to leak test.H6 component coding and investigation type, findings and conclusion coding have been updated based on the completed investigation.

• 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 ; 7814934967
• MDR Report Key: 24872147
• Report Number: 1220648-2026-06734
• Device Sequence Number: 10019662
• Product Code: OZD
• UDI-Device Identifier: 00885672009755
• UDI-Public: (01)00885672009755(17)280531(10)S9913574
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 0052-3006
• Device Lot Number: S9913574
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/06/2026
• Supplement Date Received by Manufacturer: 04/14/2026; 04/09/2026; 05/04/2026; 04/28/2026; 05/11/2026; 05/11/2026; 06/05/2026
• Initial Report FDA Received Date: 04/14/2026
• Supplement Report FDA Received Date: 04/15/2026; 04/29/2026; 05/06/2026; 05/12/2026; 05/18/2026; 05/28/2026; 06/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/11/2025
• 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: 57 YR
• Patient Sex: Male
• Patient Weight: 75 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White