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

Catalog Number CDS0702-NTW

Device Problems Material Frayed (1262); Product Quality Problem (1506); Material Protrusion/Extrusion (2979)

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

Event Date 03/23/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

This is filed to report frayed material and material protrusion.It was reported that a mitraclip procedure was performed to treat mixed mitral regurgitation (mr) grade 4 with a prolapsed posterior leaflet.During preparation, a defect was detected directly on the clip.There was a protruding, slightly pointed corner.It was also found that the nitinol was somewhat frayed at the corresponding point.It was decided not to use the clip and replace it to complete the procedure.One clip was implanted with no reported issue, reducing mr to grade <1.There was no clinically significant delay in the procedure and no adverse patient effects.No additional information was provided.

Manufacturer Narrative

The return device analysis confirmed the reported clip cover issue.A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot.Additionally, a review of the complaint history identified no other complaints reported from this lot.Based on available information and return device analysis, the reported irregular appearance on the pouch appears to be related to a potential product quality issue.Abbott will continue to trend the performance of these devices.

• 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: 16732244
• MDR Text Key: 313215412
• Report Number: 2135147-2023-01613
• 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: 05/19/2023

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 Operator: Health Professional
• Device Expiration Date: 08/11/2023
• Device Catalogue Number: CDS0702-NTW
• Device Lot Number: 20811R1066
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/23/2023
• Initial Date FDA Received: 04/13/2023
• Supplement Dates Manufacturer Received: 04/26/2023
• Supplement Dates FDA Received: 05/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/12/2022
• 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