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

Model Number CDS0706-XTW

Device Problems Off-Label Use (1494); Incomplete Coaptation (2507)

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

Event Date 12/08/2022

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, the reported image resolution poor was associated with imaging difficulty.The reported off-label use (indication for use) was associated with using the mitraclip with the tricuspid valve.The cause of the reported incomplete coaptation (intraprocedure) associated with the slda appears to be due to the off-label use in conjunction with challenging patient anatomy (pacemaker lead impingement, dilated annulus, large coaptation gap, and restricted leaflets).There is no indication of a product quality issue with respect to manufacture, design, or labeling.The additional mitraclip device referenced in event is filed under separate medwatch report number.

Event Description

This is filed to report a single leaflet device attachment (slda) and intervention.It was reported that an off label mitraclip procedure was performed to treat tricuspid regurgitation (tr) grade 4 with dilated annulus and restricted leaflets.The patient was presented with a pacemaker implanted.A xtw clip was advanced to the tricuspid valve.It was noted that the lead was likely captured in the grasp and physicians were made aware of the possibility that the gripper may be lying on the lead.The physicians decided to deploy the clip and it detached from the septal leaflet, likely due to the gripper lying on top of the lead and not having contact with leaflet tissue.Another clip was advanced to the tricuspid valve and a grasp was obtained.Several views were obtained to confirm leaflet insertion.The clip was deployed and after a couple of minutes, and single leaflet device attachment (slda) was noted.There was a large coaptation gap noted with dilated annulus in that area.Posterior leaflet likely came out due to tension.Imaging was noted to be difficult.No additional information was provided.

• 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 MEDICAL NORTHPOINT REG 3020950818; 1820 bastian court; westfield IN 46074
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 16072922
• MDR Text Key: 306381935
• Report Number: 2135147-2022-02758
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/06/2023
• Device Model Number: CDS0706-XTW
• Device Catalogue Number: CDS0706-XTW
• Device Lot Number: 21006A1042
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/08/2022
• Initial Date FDA Received: 12/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/07/2022
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 54 YR
• Patient Sex: Male
• Patient Weight: 82 KG