MAUDE Adverse Event Report: ABBOTT VASCULAR MITRACLIP XTR CLIP DELIVERY SYSTEM; VALVE REPAIR

Model Number CDS0601-XTR

Device Problems Difficult to Remove (1528); Difficult to Open or Close (2921); Material Protrusion/Extrusion (2979)

Patient Problems Atrial Perforation (2511); Foreign Body In Patient (2687)

Event Date 09/24/2020

Event Type  Injury  

Manufacturer Narrative

The device was received.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.The additional mitraclip device referenced is filed under a separate medwatch report number.

Event Description

This is filed to report atrial perforation, foreign body in patient, clip jumping and material protrusion.It was reported that this was a mitraclip procedure to treat mixed mitral regurgitation (mr) with a grade of 4.The first clip (00521u176) was implanted without issues.However, roughly four minutes after deployment, the clip detached from the posterior leaflet and remained attached to the anterior leaflet (single leaflet device attachment/slda).To stabilize the slda, a second clip was successfully implanted.To further reduce mr, a third clip was inserted and placed laterally of the two implanted clips.The clip was attempted to be deployed; however, after when pulling the actuator knob, the mandrel came our roughly three inches.It was noted that the distal end of the mandrel had detached from the clip.However, once the clip was release from the mandrel, it jumped open to roughly 120 degrees.The grippers were still attached to the leaflets, so hemostats were used to grab the gripper line and raise the grippers.The clip was able to be pulled to the tip of the steerable guide catheter (sgc), but since the clip was open, it became caught on the tip of the sgc.The clip was removed from the tip of the sgc and no damage occurred to the soft tip.A snare was then inserted through the guide and attempted to snare the nosecone of the clip in an attempt to close the clip when pulling it back into the guide.The other gripper arm was snared and was attempted to be pulled into the guide.However, when trying to cross the septum, the guide crossed with 1 clip arm into the right atrium (ra), but the snare slipped off and the clip got stuck in the atrium.The clip was re-snared on the arm that was in the ra, but even with some vigorous pulling could not get the clip through the septum, which caused damage to the septum.This resulted in a clinically significant delay in the procedure.The clip was able to be snared again, but the physician decided to undergo surgery to remove the clip.After the clip was removed, the mr was reduced to a grade of 2-3.No additional information was provided.

Manufacturer Narrative

All available information was investigated and the reported actuator mandrel protrusion could not be confirmed via returned device analysis.The reported clip jumping and difficult to remove clip delivery system (cds) from the steerable guide catheter (sgc) during use could not be replicated in a testing environment due to device returned condition (clip was not returned).In addition, the reported difficult to remove the cds from anatomy during used could not be replicated in a testing environment as it was patient related or operational circumstances.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.The investigation was unable to determine a conclusive cause for the reported clip jumping.The difficulty removing the cds from the sgc tip appears to be related to the clip opening due to the clip jumpiness.The difficulty removing the cds from the anatomy (clip got stuck on the atrium) appears to be due to troubleshooting maneuvers of the difficulty removing the cds from the sgc tip.The mandrel protrusion at the proximal end appears to be related to the user pulling the actuator knob more than expected as pulling the actuator knob will retract the mandrel; however, this is a normal function of the device.The atrial perforation appears to be due to the procedural condition of the difficulty removing the clip from the anatomy and atrial perforation is listed in the instructions for use (ifu) as a known possible complication associated with mitraclip procedures.There is no indication of a product issue with respect to manufacture, design, or labeling.H6 patient code 2687 was removed.

• Brand Name: MITRACLIP XTR CLIP DELIVERY SYSTEM
• Type of Device: VALVE REPAIR
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 10685587
• MDR Text Key: 211560746
• Report Number: 2024168-2020-08638
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 08717648226366
• UDI-Public: 08717648226366
• 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: 12/18/2020

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: 03/30/2021
• Device Model Number: CDS0601-XTR
• Device Catalogue Number: CDS0601-XTR
• Device Lot Number: 00327U144
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2020
• Initial Date Manufacturer Received: 09/24/2020
• Initial Date FDA Received: 10/15/2020
• Supplement Dates Manufacturer Received: 11/25/2020
• Supplement Dates FDA Received: 12/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: IMPLANTED MITRACLIP (X2); STEERABLE GUIDE CATHETER; IMPLANTED MITRACLIP (X2); STEERABLE GUIDE CATHETER
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 72 YR
• Patient Weight: 104