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	Hematoma (1884); Cardiogenic Shock (2262)
Date of Event	03/23/2026
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
Clinical narrative: a 66-year-old male with a history of cardiomyopathy presented in a pre support clinical state consistent with scai shock stage e.The patient was supported with an impella 5.5 device (sn (b)(6)) implanted via a right axillary/subclavian surgical arterial access on (b)(6) 2026 at 01:44 am.Following the removal of a previously placed intra aortic balloon pump (iabp), while the impella 5.5 remained in place and functioning, the patient developed significant vasodilation and hemorrhagic shock.There was clinical concern for a right sided retroperitoneal hematoma at the prior iabp access site.The patient became severely hemodynamically unstable with serum lactate levels reported as high as 10 mmol/l.Vascular surgery was consulted and continued to follow the patient; however, no surgical intervention was planned at the time of reporting due to clinical improvement.The reported event of hemorrhagic and vasodilatory shock occurred following iabp removal with suspected access site bleeding and was managed medically with improvement noted.There is no evidence at this time to suggest device malfunction, performance issue, or use error associated with the impella 5.5 system.The event appears related to patient underlying critical condition, scai shock stage e and procedural/access site complications rather than the device.The patient remains on impella support with survival outcome and explant status pending.
Additional Manufacturer Narrative
Ppae (hematoma): the root cause of the injury was not determined due to insufficient clinical details.Additional information has been provided in h6 (component code, investigation findings, type of investigation, and investigation conclusions).
Additional Manufacturer Narrative
D6b: explantation day, month and year.

• 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: 24740645
• Report Number: 1220648-2026-06136
• Device Sequence Number: 8903384
• Product Code: OZD
• UDI-Device Identifier: 00813502012828
• UDI-Public: (01)00813502012828(17)270930(10)2027824542
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Other Health Care Professional
• Type of Report: Initial,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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 1000100
• Device Lot Number: 2027824542
• 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: 03/23/2026
• Supplement Date Received by Manufacturer: 04/12/2026; 04/20/2026
• Initial Report FDA Received Date: 03/31/2026
• Supplement Report FDA Received Date: 04/14/2026; 04/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/15/2026
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White