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

Model Number	IMPELLA CP
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	Injury (2348)
Date of Event	02/12/2018
Type of Reportable Event	Death
Additional Manufacturer Narrative
The products and clinical images were requested from the field.A follow up report will be submitted if they are received and additional information is discovered.
Event or Problem Description
An impella cp was placed for support into a (b)(6) male for ami/cgs.Pump flows were low and position alarms were triggered immediately after the pump was started.Echo imaging revealed papillary muscle head and tendinous chords were drawn into the pump inlet.The clinical team repeatedly attempted to reposition the device.The patient's condition was deteriorating therefore the pump was removed.The patient expired due to cardiogenic shock.

• Brand Name: IMPELLA CP
• Common Device Name: TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP
• Manufacturer (Section D): ABIOMED, INC.; 22 cherry hill drive; danvers MA 01923
• MDR Report Key: 7472345
• Report Number: 1220648-2018-00031
• Device Sequence Number: 11164738
• Product Code: OZD
• UDI-Device Identifier: 00813502011258
• UDI-Public: 00813502011258
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: P1400003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/03/2018

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: Physician
• Device Expiration Date: 02/28/2019
• Device Model Number: IMPELLA CP
• Device Catalogue Number: 0048-0002
• Device Lot Number: 1282175
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/03/2018
• Initial Report FDA Received Date: 04/30/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention; Disability
• Patient Age: 67 YR