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

Model Number	IMPELLA LD AIC PUMP SET US
Medical Device Problem Code	Increase in Pressure (1491)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	08/14/2021
Type of Reportable Event	Death
Event or Problem Description
Us complainant reported the patient with unknown ethnicity was on impella ld for hemodynamic support.While on support low purge flow, high purge pressure alarms, and bleeding was noted.Tpa was administered in the impella purge due to purge alarms.Heparin was removed from purge due to bleeding.It was reported that the patient expired on support.There is not enough information to exclude the impella device as an associated factor in the patient's demise.
Additional Manufacturer Narrative
The investigation for the reported issue has been completed.The impella device was not received from the customer.Due to the limited clinical information and lack of available data/product the root cause of this investigation is not determined.

• Brand Name: IMPELLA LD
• 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: 20813677
• Report Number: 1220648-2024-24450
• Device Sequence Number: 9830575
• Product Code: OZD
• UDI-Device Identifier: 00813502011227
• UDI-Public: (01)00813502011227(10)1498346(17)220731
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: P140003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/30/2024

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 Expiration Date: 07/31/2022
• Device Model Number: IMPELLA LD AIC PUMP SET US
• Device Catalogue Number: 005082
• Device Lot Number: 1498346
• 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: 08/14/2021
• Initial Report FDA Received Date: 11/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/24/2020
• 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: Death
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Race: White