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

Catalog Number CDS0705-XTW

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

Patient Problem Unspecified Tissue Injury (4559)

Event Date 07/13/2023

Event Type  Injury  

Manufacturer Narrative

The device has been received.However, investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

This will be filed to report a gripper line break, a single gripper actuation issue, a device that was difficult to remove, and a tissue injury.It was reported that a mitraclip procedure was performed to treat degenerative mitral regurgitation (mr) grade 4 with a flail.During grasping attempts, the anterior gripper was noted to be the only functioning gripper.Upon inspection a gripper line break was observed.The clip was retracted to the steerable guide catheter (sgc).However, it this time chordae was found in the gripper and it was suspected that the chordae was caught on the clip prior to removal.The clip was exchanged and two clips were placed.The procedure was then concluded with a resulting mr of grade 1-2.There was no clinically significant delay in the procedure and no additional information was provided.

Manufacturer Narrative

All available information was investigated, and the reported break (gripper line) and difficult to open or close (gripper actuation ¿ single) was confirmed via returned device analysis.The reported difficult to remove (anatomy) could not be replicated in a testing environment.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 and results of the analysis, the reported single gripper actuation issue (tactile marker side) was due to a broken gripper line.The reported difficult to remove (anatomy), associated with the chordal entanglement on the posterior side (non-tactile), was due to procedural circumstances during leaflet grasping.A cause of the reported gripper line break (tactile marker side) could not be determined.The reported tissue injury was due to the chordal entanglement and attempts to free.The reported patient effect of tissue injury, as listed in the mitraclip system instructions for use (ifu), is a known possible complication associated with mitraclip procedures.The reported unexpected medical intervention was a result of case-specific circumstances.There is no indication of a product quality issue with respect to manufacture, design, or labeling.

Event Description

N/a.

• Brand Name: MITRACLIP G4 CLIP DELIVERY SYSTEM (MDD)
• 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: 17456086
• MDR Text Key: 320369440
• Report Number: 2135147-2023-03409
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 09/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/25/2024
• Device Catalogue Number: CDS0705-XTW
• Device Lot Number: 30327R1111
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/27/2023
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 81 YR
• Patient Sex: Female
• Patient Weight: 51 KG