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

Model Number IMPELLA CP

Device Problem Device Issue (2379)

Patient Problems Low Blood Pressure/ Hypotension (1914); Perforation (2001); Blood Loss (2597)

Event Date 01/26/2018

Event Type  Injury  

Manufacturer Narrative

The product was returned for analysis.The data logs are not relevant to the failure mode, and were not gathered for analysis.There was damge noted on the 15fr portion of the pump, at the wound closure.The timing of when the damage occurred is unknown.The damage most likely contributed to the bleeding observed during the case support.The root cause of the bleeding is unable to be determined.The failure will be monitored and trended.(b)(4).

Event Description

A (b)(6) male was admitted with influenza.In his workup multivessel coronary artery disease was diagnosed.He was sent for bypass surgery with impella cp being utilized for hemodynamic support.After the bypass grafts were placed, and the patient was taken off-pump, the impella groin access site was seen to have pulsatile blood flow.Due to the blood loss, the impella was explanted, and the patient had a surgical intervention and repair of the torn common femoral artery.A new impella cp was placed for continued support at the left femoral artery, via a newly placed 6cm hemashield platinum graft, and his hemodynamic support continued until support was withdrawn at the request of the family.

• Brand Name: IMPELLA CP
• Type of Device: TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP
• Manufacturer (Section D): ABIOMED; 22 cherry hill drive; danvers MA 01923
• Manufacturer (Section G): ABIOMED; 22 cherry hill drive; danvers MA 01923
• Manufacturer Contact: ralph barisano ; 22 cherry hill drive; danvers, MA 01923 ; 9786461400
• MDR Report Key: 7282770
• MDR Text Key: 100452190
• Report Number: 1220648-2018-00005
• Device Sequence Number: 1
• Product Code: OZD
• UDI-Device Identifier: 00813502011258
• UDI-Public: 00813502011258
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P140003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 07/31/2019
• Device Model Number: IMPELLA CP
• Device Catalogue Number: 0048-0003
• Device Lot Number: 1299265
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/26/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/08/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 77 YR