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

Model Number	IMPELLA CP PUMP SET, US
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/03/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned and evaluated.The lower portion of the impeller blade was found to be fractured.Simulated use testing resulted in lower than expected pump flow.The cause of the broken impeller blades could not be definitively determined, however, evidence suggests the blades came into contact with a foreign object inside the pump housing windows.Note: this mdr is being reported late dueto retrospective analysis of prior broken impeller blade complaints.
Event or Problem Description
The complainant reported a (b)(6) male patient presenting for high risk percutaneous coronary intervention.The impella cp was selected for hemodynamic support.Shortly after support was initiated, the pump exhibited continuous suction alarms.The pump was removed and replaced without further issue.An investigation was completed on the returned device and broken impeller blades were identified.

• Brand Name: IMPELLA CP
• Common Device Name: TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP
• Manufacturer (Section D): ABIOMED, INC.; 22 cherry hill dr.; danvers MA 01923
• MDR Report Key: 12533949
• Report Number: 1220648-2021-01054
• Device Sequence Number: 1361587
• Product Code: OZD
• UDI-Device Identifier: 00813502011258
• UDI-Public: (01)00813502011258(10)1250794(17)180630
• 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
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/27/2021

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 Expiration Date: 06/30/2018
• Device Model Number: IMPELLA CP PUMP SET, US
• Device Catalogue Number: 0048-0003
• Device Lot Number: 1250794
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2016
• Distributor Facility Aware Date: 10/07/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/14/2016
• Initial Report FDA Received Date: 09/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 62 YR