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

Catalog Number CDS0702-XT

Device Problems Break (1069); Difficult to Remove (1528); Difficult to Open or Close (2921); Unintended Movement (3026)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 01/18/2023

Event Type  Injury  

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 incidents reported from this lot.Based on available information, and without the device to analyze, the reported image resolution poor was associated with difficult imaging.The reported difficult to open or close (gripper actuation ¿ single) associated with the gripper that was unable to actuate was due to the gripper line break.The reported break (cga gripper line) associated with the gripper line break, and the reported unspecified tissue injury associated with the chordae rupture, appear to be due to the difficulty in removing the clip from anatomy.The reported difficult to remove (anatomy) associated with the chordae entanglement appears to be due to procedural circumstances (clip interacting with patient pathology/ morphology).The cause of the reported unintended movement (sleeve steering issues) associated with the clip colliding with the valve could not be determined.The reported patient effect of tissue injury, as listed in the mitraclip system instructions for use, is a known possible complication associated with mitraclip procedures.The reported serious injury/ illness/ impairment 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

This is filed to report tissue damage, unintended movement, difficult removal, and a gripper actuation issue it was reported this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 4.It was noted imaging was difficult.One clip was successfully implanted.To further reduce mr, an xt clip was inserted.However, while in the left ventricle (lv), the clip moved in an unintended direction, resulting in interaction with the valve and chordae.The clip was able to be removed from the chordae, but a chordal rupture was observed.It was then observed that one of the grippers was no longer working.Therefore, the clip was removed and replaced.Two additional clips were implanted, but mr remained at a grade of 4.There was no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

All available information was investigated, and the reported unintended movement (sleeve steering issues) was not confirmed via device analysis.The reported difficult to remove (anatomy) and image resolution poor could not be replicated in a testing environment.The returned device analysis confirmed the reported difficult to open or close (gripper actuation ¿ single) and break (cga gripper line).Additionally, the independent gripper assembly cover tab was observed to be broken.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 incidents reported from this lot.Based on available information, the reported image resolution poor was associated with difficult imaging.The reported/ observed difficult to open or close (gripper actuation ¿ single) associated with the gripper unable to actuate was due to the gripper line break.The reported/ observed break (cga gripper line) associated with the gripper line break, and the reported unspecified tissue injury associated with the chordae rupture, appear to be due to the difficulty in removing the clip from anatomy.The reported difficult to remove (anatomy) associated with the chordae entanglement appears to be due to procedural circumstances (clip interacting with patient pathology/ morphology).The cause of the reported unintended movement (sleeve steering issues) associated with the clip colliding with the valve could not be determined.The cause of the observed break (gripper lever cover) associated with the gripper assembly cover tab break could not be determined.The reported patient effect of tissue injury, as listed in the mitraclip system instructions for use, is a known possible complication associated with mitraclip procedures.The reported serious injury/ illness/ impairment was a result of case-specific circumstances.There is no indication of a product quality issue with respect to manufacture, design, or labeling.H6: component code 4115 removed.

• 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: 16274958
• MDR Text Key: 308523605
• Report Number: 2135147-2023-00346
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 04/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/05/2023
• Device Catalogue Number: CDS0702-XT
• Device Lot Number: 20906R1070
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/03/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/06/2022
• 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): Other
• Patient Age: 85 YR
• Patient Sex: Male