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

Model Number CDS0501

Device Problem Activation, Positioning or Separation Problem (2906)

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

Event Date 05/18/2018

Event Type  malfunction  

Event Description

Mitra clip - gripper line malfunctioned.A clip was placed on the medial side of a2/p2 with excellent reduction in mr but could not be implanted due to device malfunction (the lock line could not be removed despite multiple attempts).The device was able to be unlocked and removed completely from the body and a new clip was then successfully placed and implanted.

• Brand Name: MITRACLIP
• Type of Device: MITRAL VALVE REPAIR DEVICES
• Manufacturer (Section D): ABBOTT VASCULAR INC.; 26531 ynez road; temecula CA 92591
• MDR Report Key: 7577584
• MDR Text Key: 110346481
• Report Number: 7577584
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/22/2018

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: Physician
• Device Expiration Date: 05/18/2018
• Device Model Number: CDS0501
• Device Catalogue Number: CDS0501
• Device Lot Number: 80316U203
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/22/2018
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 05/22/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/07/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 85 YR