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

Model Number 1153

Device Problem Misassembled (1398)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/22/2018

Event Type  malfunction  

Manufacturer Narrative

This device is used for treatment not diagnosis.The ventricular assist system is indicated for use as a bridge to cardiac transplantation and destination therapy in patients who are at risk of death from refractory end-stage left ventricular heart failure.The system is designed for in-hospital and out-of-hospital settings.Product event summary: the sewing ring with unknown lot number, along with its accessories, was not returned for evaluation.The reported event could not be confirmed since the components were not returned and no evidence or supporting data was provided.There is no evidence to suggest that a component malfunction caused or contributed to the reported event.Based on historical review of similar events, the most likely root cause of the reported damage can be attributed to excessive stress applied by tightening the screw at an angle due to limited access to the implant site or the screw was not fully supported by the sewing ring clamp, which could be caused by the user backing the screw out of the intended position, resulting in the screw breaking under load.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that there was damage to the sewing ring during prep prior to implantation.The perfusionist attempted to fit the sewing ring over the o-ring to ensure a proper fit but the screw popped off each of the three attempts.A new sewing ring from an accessories kit was used instead with no further issues.No patient complications have been reported as a result of this event.

• Brand Name: HEARTWARE VENTRICULAR ASSIST SYSTEM- SEWING RING
• Type of Device: VENTRICULAR (ASSIST) BYPASS
• Manufacturer (Section D): HEARTWARE, INC.; 14400 nw 60th ave; miami lakes FL 33014
• Manufacturer (Section G): HEARTWARE, INC.; 14400 nw 60th ave; miami lakes FL 33014
• Manufacturer Contact: lisa robertson ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635262723
• MDR Report Key: 8464228
• MDR Text Key: 140314071
• Report Number: 3007042319-2019-05200
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1153
• Device Catalogue Number: 1153
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/22/2018
• 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
• Treatment: 1103 VAD
• Patient Age: 67 YR
• Patient Weight: 68