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

Catalog Number CDS0706-XTW

Device Problems Difficult to Remove (1528); Difficult to Open or Close (2921); Expulsion (2933); Material Deformation (2976); Mechanical Jam (2983); Unintended Movement (3026)

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

Event Date 09/29/2023

Event Type  Injury  

Event Description

It was reported that a mitraclip procedure was performed to treat degenerative mitral regurgitation (mr) grade 4 with prolapsed posterior and anterior leaflets, severely dilated right and left atrium, and flail.It was noted that a left ventricular assist device (lvad) was placed prior to the procedure due to the patient's pre-existing status.An xtw clip was placed on the mitral valve.The first establishing final arm angle (efaa) went smoothly.However, during lock line removal, difficulties were encountered.The lock line was able to be removed 5-6 inches, but then met resistance.A knot was suspected.An attempt was made to invert and remove the clip.However, it was not possible to unlock the clip.Troubleshooting was performed and was unsuccessful.It was decided to deploy the clip while still jammed to the lock line.The clip delivery system was difficult to remove and had to be walked out over the lock line to remove into the steerable guide catheter (sgc).While walking the clip delivery system (cds) over the lock line, the clip opened to 40 degrees and detached off of both leaflets.The clip had moved into the left atrium, while still attached to the lock line.The guide and the clip were pulled into the atrium.The clip and the guide were pulled back through the femoral vein to the groin, but difficulties removing the system occurred.A cut down was performed to remove the clip, as the size of the clip at its open and unsheathed state was larger than it was originally at the access site to the vein.The clip was removed out of the femoral vein.Three clips were then implanted without issues.The mr was reduced to grade 1.There were no issues with visualizing the clips during the procedure.The patient was reported to be stable throughout the procedure.No additional information was provided.

Manufacturer Narrative

Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

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 complaints reported from this lot.Based on available information and without the device to analyze, a cause of the reported mechanical jam (lock line ¿ inability), associated with difficult lock line removal, could not be determined.A cause of the reported material deformation, associated with the lock line knot being suspected, could not be determined.A cause of the reported difficult to open or close (clip open inability ¿ anatomy), associated with the inability to unlock clip, could not be determined.The reported difficult to remove (anatomy), associated with removing the cds (clip delivery system) over the lock line, was due to the lock line getting jammed and the cds had to be removed separately without the lock line.The reported unintended movement (clip open while locked) associated with clip opening during cds removal, appears to be due to cds removal over the lock line, as the lock line could be tensioned during the removal process causing the clip to unlock.The reported expulsion (ccd, complete clip detachment) was due to the unintended clip opening.The reported unexpected medical intervention, surgical intervention, and delay to treatment/ therapy were results of case-specific circumstances.There is no indication of a product quality issue with respect to manufacture, design, or labeling.

• Brand Name: MITRACLIP G4 CLIP DELIVERY SYSTEM (MDR)
• 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: 17994656
• MDR Text Key: 326364919
• Report Number: 2135147-2023-04619
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 05415067037381
• UDI-Public: 05415067037381
• 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: 11/14/2023

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 Catalogue Number: CDS0706-XTW
• Device Lot Number: 30711R1044
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/29/2023
• Initial Date FDA Received: 10/24/2023
• Supplement Dates Manufacturer Received: 11/06/2023
• Supplement Dates FDA Received: 11/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/11/2023
• 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