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

Model Number CDS0701-NT

Device Problems Break (1069); Positioning Failure (1158); Difficult to Remove (1528); Difficult to Open or Close (2921)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 12/15/2022

Event Type  Injury  

Manufacturer Narrative

The device will not be returned for evaluation as the device was reportedly discarded.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.The additional mitraclip device referenced in b5 is being filed under a separate medwatch report number.

Event Description

This is filed to report a gripper actuation issue, difficult to remove, and tissue damage it was reported this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 4 and a flail.One clip was successfully implanted on the central/medial side of a2/p2, reducing mr to a grade of 1-2.A jet remained on the lateral side of a2/p2; therefore, an nt (20503r196) was prepared.However, during preparation, it was observed the clip did not open smoothly.Therefore, the clip was not used and another nt (208091061) was prepared and inserted under the mitral valve.Grasping was performed, but it was noted a gripper issue occurred resulting in difficult grasping the leaflets.It was then observed the clip because caught in chordae.The clip was able to be removed, but a chordal rupture occurred, causing mr to increase to an grade of 3.To treat the tissue damage and mr, an ntw (20615r120) was inserted and advanced in the left ventricle (lv).However, this clip became caught in chordae and the leaflets were difficult to grasp.A new flail and more chordal ruptures were observed, causing mr to increase to a grade of 4.Therefore, the clip was removed, and the procedure was discontinued.There was no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

The device was not returned for analysis.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 identified no similar complaints reported from this lot.Based on available information a cause for the reported difficulty removing the clip from anatomy could not be determined.The reported break, single gripper actuation issue, and positioning failure (leaflet grasping ¿ clip not implanted) appear to be cascading events of the difficulty removing the clip from anatomy.The reported tissue injury appears to be a cascading event of the difficulty removing the clip from anatomy.Additionally, tissue injury is listed in the ifu as a known possible complication associated with mitraclip procedures.The reported unexpected medical intervention (additional mitraclip, same procedure) is the result of case-specific circumstances.There is no indication of product 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: 16099946
• MDR Text Key: 306679365
• Report Number: 2135147-2023-00033
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 08717648230943
• UDI-Public: 08717648230943
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 02/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/08/2023
• Device Model Number: CDS0701-NT
• Device Catalogue Number: CDS0701-NT
• Device Lot Number: 20809R1061
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/09/2022
• 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: IMPLANTED MITRACLIP; STEERABLE GUIDE CATHETER
• Patient Outcome(s): Required Intervention
• Patient Age: 80 YR
• Patient Sex: Male
• Patient Weight: 67 KG