MAUDE Adverse Event Report: HEARTWARE-MEDTRONIC HEARTWARE; LVAD

Model Number HW27938

Device Problem Occlusion Within Device (1423)

Patient Problems Failure of Implant (1924); Cardiogenic Shock (2262)

Event Date 10/29/2017

Event Type  Injury  

Event Description

Surgeon reports device malfunction complicated by cardiogenic shock and pump exchange was recommended.Outflow graft was dissected and encircled.

• Brand Name: HEARTWARE
• Type of Device: LVAD
• Manufacturer (Section D): HEARTWARE-MEDTRONIC; 14400 nw 60th ave; miami lakes FL 33014
• MDR Report Key: 7066949
• MDR Text Key: 93359375
• Report Number: 7066949
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 11/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HW27938
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 10/29/2017
• Event Location: Hospital
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR
• Patient Weight: 120