MAUDE Adverse Event Report: HEARTWARE, INC. HEARTWARE VENTRICULAR ASSIST SYSTEM; VENTRICULAR (ASSISST) BYPASS

Catalog Number 1103

Device Problem Occlusion Within Device (1423)

Patient Problem Thrombus (2101)

Event Date 06/16/2018

Event Type  malfunction  

Event Description

Patient with a heartware hvad implanted in (b)(6) 2014 developed a splenic infarct while on therapeutic anticoagulation.The patient's device was interrogated and no increased power was noted.A cardiac echo did not reveal thrombus in the heart.The patient did well while in the hospital and was discharged two days after admission.

• Brand Name: HEARTWARE VENTRICULAR ASSIST SYSTEM
• Type of Device: VENTRICULAR (ASSISST) BYPASS
• Manufacturer (Section D): HEARTWARE, INC.; 14400 nw 60th ave; miami lakes FL 33014
• MDR Report Key: 7641124
• MDR Text Key: 112446673
• Report Number: 7641124
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 1103
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/20/2018
• Device Age: 4 YR
• Event Location: Home
• Date Report to Manufacturer: 06/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 15330 DA
• Patient Weight: 121