MAUDE Adverse Event Report: ABIOMED, INC. IMPELLA 5.5; TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP

Model Number	IMPELLA 5.5
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	11/17/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The impella device was not received from the customer, therefore, investigation of the device was not possible.Should the device or any new information be received, a supplemental mdr will be filed.
Event or Problem Description
Abiomed japan forwarded 7 publications.One from team in ct/(b)(6) hospital which was entitled: "one pump for two hearts: using an impella 5.5 micro-axial pump in peripartum cardiogenic shock" which details a cp support in an expectant mother who had an access site ooze.Until the day before delivery, she was anticoagulated with heparin, along with a heparin-based purge fluid.A day before delivery, she developed epistaxis and oozing from the impella placement site.Anticoagulation was temporarily stopped, and the heparin-based purge fluid was substituted with 5% dextrose but oozing continued.Ultimately a decision to proceed with delivery was made due to persistent oozing despite holding heparin and severe fetal growth restriction.The procedure was successful with another device and the procedural outcome was the patient survived surgery.
Additional Manufacturer Narrative
The investigation of access site bleeding has been completed.The impella device was not returned for evaluation.Without additional clinical details, the root cause of the reported issues could not be determined.Article citation: pillai, a.A., badr, m., mai, x., dilip, a., & bell, j.(2024).One pump for two hearts: using an impella 5.5 micro-axial pump in peripartum cardiogenic shock.Asaio journal, 70(11), e159¿e161.Https://doi.Org/10.1097/mat.0000000000002215 e4 should have been left blank on manufacturer device report 1220648-2024-25146.G2 report source; literature was inadvertently not selected on manufacturer device report 1220648-2024-25146.H10 article citation was omitted from manufacturer device report 1220648-2024-25146.Article was inadvertently not attached on manufacturer device report 1220648-2024-25146.

• Brand Name: IMPELLA 5.5
• Common Device Name: TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP
• Manufacturer (Section D): ABIOMED, INC.; 22 cherry hill dr.; danvers MA 01923
• Manufacturer (Section G): ABIOMED, INC.; 22 cherry hill dr.; danvers MA 01923
• Manufacturer Contact: derek sammarco
• MDR Report Key: 21021688
• Report Number: 1220648-2024-25146
• Device Sequence Number: 11779931
• Product Code: OZD
• UDI-Device Identifier: 00813502011531
• UDI-Public: (01)00813502011531(10)2023256411(17)240731
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: P140003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Literature,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/29/2025

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 Expiration Date: 07/31/2024
• Device Model Number: IMPELLA 5.5
• Device Catalogue Number: 0550-0008
• Device Lot Number: 2023256411
• 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: 12/11/2024
• Supplement Date Received by Manufacturer: 01/19/2025
• Initial Report FDA Received Date: 12/26/2024
• Supplement Report FDA Received Date: 01/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/06/2022
• 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: 27 YR
• Patient Sex: Female