MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. MITRACLIP; MITRAL VALVE REPAIR DEVICES

Model Number CDS0706-XTW

Patient Problem Insufficient Information (4580)

Event Date 07/13/2023

Event Type  malfunction  

Event Description

Patient to operating room for mitral regurgitation and possible mitral valve repair or replacement.Patient had an abbott mitral clip applied approximately 3 months ago.Upon inspection during surgical procedure it was noted that the clip appeared to be holding both anterior and posterior leaflets in the midportion however there was approximately a 3 & 1/2 mm gap at the tip.The clip with separation at the tip was excised and sent to lab for identification.

• Brand Name: MITRACLIP
• Type of Device: MITRAL VALVE REPAIR DEVICES
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 17539809
• MDR Text Key: 321059972
• Report Number: 17539809
• 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: 07/14/2023

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 Model Number: CDS0706-XTW
• Device Catalogue Number: CDS0706-XTW
• Device Lot Number: 21213R1021
• 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: 07/14/2023
• Event Location: Hospital
• Date Report to Manufacturer: 08/14/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/14/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 29200 DA
• Patient Sex: Female
• Patient Weight: 69 KG