MAUDE Adverse Event Report: ABBOTT MEDICAL MITRACLIP G4 CLIP DELIVERY SYSTEM; MITRAL VALVE REPAIR DEVICES

Model Number N/A

Device Problems Break (1069); Material Frayed (1262); Difficult to Open or Close (2921)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/04/2022

Event Type  malfunction  

Event Description

This filed to report the broken lock line and frayed lock line.It was reported that the initial mitraclip procedure was performed on (b)(6) 2022, to treat degenerative mitral regurgitation (mr) with a grade of 4.The mitraclip was positioned above the mitral valve.Upon the initial attempt to open the clip in the left atrium it was not possible to open the clip.Another attempt was made by pulling the lock lever slightly above the blue line.It was still not possible to open the clip with the arm positioner after several attempts.The closed clip was easily removed.Another clip was used to complete the procedure with no issues.One clip total was implanted reducing the mr to 1.There was no clinically significant delay in the procedure and no adverse patient effects.No additional information was provided.In addition to reported information the returned device analysis noted that the device was returned with a broken l-lock tab and a frayed locked line.

Manufacturer Narrative

Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Manufacturer Narrative

All available information was investigated, and the reported difficult to open the clip was confirmed via returned device analysis.Bent frictional elements, frayed lock line with slack, and a broken/twisted/scratched l-lock tab was observed.A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history did not indicate a lot-specific quality issue.Based on available information and the returned device analysis, the cause of the reported difficult to open the clip was unable to be determined.The observed frayed lock line appears to be related to troubleshooting maneuvers to resolve clip open inability.The cause of the observed lock line slack, broken/twisted/scratched l-lock tab, and bent frictional elements were unable to be determined.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• Brand Name: MITRACLIP G4 CLIP DELIVERY SYSTEM
• Type of Device: MITRAL VALVE REPAIR DEVICES
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005070406; 3885 bohannon drive; menlo park CA 94025
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 15447733
• MDR Text Key: 302277464
• Report Number: 2135147-2022-01244
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P100009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/22/2023
• Device Model Number: N/A
• Device Catalogue Number: CDS0702-XTW
• Device Lot Number: 20222R277
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/21/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/23/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: STEERABLE GUIDE CATHETER.