MAUDE Adverse Event Report: ABBOTT VASCULAR MITRACLIP; CATHETER, STEERABLE

Lot Number 81102U111

Device Problem Difficult to Open or Close (2921)

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

Event Date 12/27/2018

Event Type  malfunction  

Event Description

The patient required additional measures performed to retrieve the failed clip and then complete the mitral valve repair, which resulted in prolonged anesthesia, fluoro time, and procedure length.When we were to deploy the clip, we noticed that the clip that was closed opened spontaneously for unclear reasons.Multiple attempts were performed to reclose the clips, but these efforts were unsuccessful.After spending at least forty-five minutes doing various maneuvers, it was decided to send the patient to surgery.Another provider was consulted and was kind to come to the cath lab for evaluation from ct standpoint.An additional provider was consulted to help with potential surgical means of removing the clip.The clip was released, but the clip and gripper lines were not released.After placing a wire in the left atrium, the mitraclip moved back spontaneously.Once the device was in the ivc, we were able to snare the device into the guide using a ensare.

• Brand Name: MITRACLIP
• Type of Device: CATHETER, STEERABLE
• Manufacturer (Section D): ABBOTT VASCULAR; 3885 bohannon drive; menlo park CA 94025
• MDR Report Key: 8304507
• MDR Text Key: 135005473
• Report Number: 8304507
• Device Sequence Number: 1
• Product Code: DRA
• 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: 01/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 81102U111
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/11/2019
• Event Location: Hospital
• Date Report to Manufacturer: 02/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 31390 DA
• Patient Weight: 70