MAUDE Adverse Event Report: ABBOTT VASCULAR INC. MITRACLIP; MITRAL VALVE REPAIR DEVICES

Catalog Number CDS0601-NTR

Device Problems Difficult to Open or Close (2921); Physical Resistance/Sticking (4012)

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

Event Date 10/10/2019

Event Type  malfunction  

Event Description

During clip insertion, some resistance was evident.It prepped correctly and flushed and it advanced through the guide into the la.Upon initial opening of the clip in the la, the clip would not open past 60 degrees.The clip was closed and reopened several times, but it would not open past the 60 degree mark.When closing the clip, the mandrel appeared to have disconnected from the clip (on fluoro).This created a small asd with left to right shunt only.System was completely removed from the patient without further complication and procedure was aborted.

• Brand Name: MITRACLIP
• Type of Device: MITRAL VALVE REPAIR DEVICES
• Manufacturer (Section D): ABBOTT VASCULAR INC.; 26531 ynez rd; temecula CA 92591
• MDR Report Key: 9481097
• MDR Text Key: 171618612
• Report Number: 9481097
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/25/2019,10/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CDS0601-NTR
• Device Lot Number: 90401U123
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/25/2019
• Event Location: Other
• Date Report to Manufacturer: 12/17/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 31025 DA