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

Model Number CDS0701-XTW

Device Problems Off-Label Use (1494); Improper or Incorrect Procedure or Method (2017); Difficult or Delayed Activation (2577); Expulsion (2933)

Patient Problem Embolism (1829)

Event Date 01/19/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device has been received, but the investigation has not been completed.A follow-up report will be submitted with all additional relevant information.

Event Description

This is filed to report difficult clip deployment, complete clip detachment and embolism it was reported that this was a mitraclip procedure to treat tricuspid regurgitation (tr) with a grade of 3+.Prior to inserting the devices, it was noted that the patient had an implanted cardioverter defibrillator (icd).One xtw was successfully implanted without issues, reducing tr to a grade of 2+.To further reduce tr, a second xtw clip (00928u137) was inserted, but when in the right atrium (ra) the clip was unable to open.Troubleshooting was performed, but the clip was still unable to open.The decision was made to remove the clip and replace it with an additional xtw.The xtw clip (01027u260) was inserted and the anterior and posterior leaflets were successfully grasped.The clip was attempted to be deployed; however, it was noted that the second final arm angle (faa) test was not performed.While attempting to deploy the clip, after turning the actuator knob, the mandrel did not release from the clip.Troubleshooting was performed and the mandrel was able to detach from the clip.However, the troubleshooting caused the clip to completely detach from both leaflets and embolize in the ra.The clip delivery system (cds) was removed and a snare was inserted.The embolized clip was able to be snared and was successfully removed with the steerable guide catheter (sgc).No additional clips were implanted.There was no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

The reported complete clip detachment and off-label use (use in the tricuspid valve) could not be replicated in a testing environment as they were related to patient/procedural conditions.The reported difficult clip deployment could not be replicated in a testing environment due to the condition of the returned device (clip was detached).The reported failure to follow steps/instructions during procedure could not be replicated in a testing environment due to it being associated with user error.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.It should be noted that per the mitraclip system instructions for use (ifu) states: ¿the mitraclip¿ g4 system is indicated for the percutaneous reduction of significant symptomatic mitral regurgitation (mr).Based on the available information, the reported off-label use was due to the device being used on a tricuspid valve.Additionally, the ifu indicates to ¿establish final arm angle¿ as part of the mitraclip g4 implant pre-deployment clip assessment.Since the user did not perform this second efaa step and failed to follow the ifu, this is considered as a deviation from the ifu.A cause for the reported difficult clip deployment could not be determined.The reported complete clip detachment appears to have been a result of procedural conditions.The reported patient effect of embolism was a cascading event of the reported complete clip detachment.Embolism is listed in the mitraclip system instructions for use as a known possible complication associated with mitraclip procedures.The reported removal of foreign body was a result of case-specific circumstances, as the embolized clip was snared and successfully removed.There is no indication of a product quality issue with respect to manufacture, design or labeling.Na.

• Brand Name: MITRACLIP G4 CLIP DELIVERY SYSTEM
• Type of Device: MITRAL VALVE REPAIR DEVICES
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 11318549
• MDR Text Key: 231539308
• Report Number: 2024168-2021-01129
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 08717648231001
• UDI-Public: 08717648231001
• Combination Product (y/n): N
• PMA/PMN Number: P100009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 03/11/2021

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: 10/26/2021
• Device Model Number: CDS0701-XTW
• Device Catalogue Number: CDS0701-XTW
• Device Lot Number: 01027U260
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2021
• Initial Date Manufacturer Received: 01/19/2021
• Initial Date FDA Received: 02/11/2021
• Supplement Dates Manufacturer Received: 02/16/2021
• Supplement Dates FDA Received: 03/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: IMPLANTED MITRACLIP; STEERABLE GUIDE CATHETER; IMPLANTED MITRACLIP; STEERABLE GUIDE CATHETER
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR
• Patient Weight: 73