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

Model Number CDS0701-XTW

Device Problems Material Separation (1562); Unstable (1667); Noise, Audible (3273)

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

Event Date 11/29/2022

Event Type  Injury  

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 actuator knob and shaft separation requiring intervention.It was reported that a mitraclip procedure was performed to treat functional mitral regurgitation (fmr) with grade 4+ and restricted anterior and posterior leaflets.A mitraclip xtw was selected for treatment, but while turning the arm positioner, a pop was felt.It was noted that everything was still stable, the procedure continued and the deployment process began.The actuator knob was turned 8 times.While pulling back the actuator knob, the entire actuator and the actuator shaft came out.Forceps were used to turn the mandrel to deploy the clip.The clip was deployed and following deployment, was stable on both leaflets.The procedure was completed with two clips implanted.The mr was reduced to 1-2.There was no clinically significant delay in the procedure and no adverse patient effects.No additional information was provided.

Event Description

Subsequent to the previously filed report, additional information was received: after actuation, during deployment, a ¿pop¿ was heard.Also, while rotating the actuator knob, it was suspected to be looser than normal.No additional information was provided.

Manufacturer Narrative

The returned device analysis could not replicate the reported noise and unstable (knob - loose) in a testing environment due to the returned condition of the device.The reported material separation (actuator & actuator knob) was confirmed by the return device analysis.Moreover, the collect was observed to be corroded and two tines were broken.The actuator coupler was stuck in the l-lock shaft and was unable to be removed.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 similar complaints reported from this lot.Based on the information available and returned analysis, the observed broken collet tine appears to be a potential product quality issue.This complaint is within the scope of an exception escalation as the complaint description and device code match the specific issue described in the exception.The broken collet possibly contributed to the noise heard during the procedure.The reported material separation and unstable are cascading effect of the observed broken collet tine.The observed corroded collect was likely an outcome of post procedural conditions (exposure to saline solution).The cause for the observed actuator coupler getting stuck in the l-lock shaft and unable to be removed appears to be due to the return device condition (coupler retracted beyond l-lock tabs to the radiopaque tip ring).The reported unexpected medical intervention was the result of case-specific circumstances.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: 16045674
• MDR Text Key: 306152708
• Report Number: 2135147-2022-02720
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 08717648231001
• UDI-Public: 08717648231001
• 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,Followup
• Report Date: 03/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/06/2023
• Device Model Number: CDS0701-XTW
• Device Catalogue Number: CDS0701-XTW
• Device Lot Number: 20907R1044
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/07/2022
• 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: 73 YR
• Patient Sex: Female
• Patient Weight: 57 KG