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

Model Number CDS0601-XTR

Device Problems Activation, Positioning or Separation Problem (2906); Physical Resistance/Sticking (4012)

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

Event Date 04/09/2019

Event Type  malfunction  

Event Description

From staff: nitinol strings attached to the mitra clips would not release.Nitinol strings were cut just below the skin at the right femoral vein site and strings remain attached to the mitra clip.The gripper line failed to release from the implant, but the implant itself functioned properly.Took the device for review.Recommended cutting the string below the level of the skin and otherwise leaving in place, as there was no way to cut it closer to the valve.From op report: initially there was significant improvement of mitral regurgitation from sever to mild to moderate.At the last step (retrieving the grippers line), there was significant resistance pulling the wire, multiple attempts were made to retrieve the gripper line, including repositioning of the entire system, dismantling the cds and for the try using an mp 5f catheter as a support catheter without success.At this point, after consulting with the abbott representative, it was decided to leave the gripper line in place since there was evidence of worsening metabolic rate while trying to pull this line.Finally, the line was cut at the groin level.

• Brand Name: MITRACLIP
• Type of Device: MITRAL VALVE REPAIR DEVICES
• Manufacturer (Section D): ABBOTT VASCULAR, INC.; 3885 bohannon drive; menlo park CA 94025
• MDR Report Key: 8577332
• MDR Text Key: 143977982
• Report Number: 8577332
• 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: 04/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CDS0601-XTR
• Device Catalogue Number: CDS0601-XTR
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/16/2019
• Event Location: Hospital
• Date Report to Manufacturer: 05/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 33945 DA
• Patient Weight: 50