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

Catalog Number CDS0706-XTW

Device Problem Unintended Movement (3026)

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

Event Date 04/04/2024

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that a patient presented with grade 4 mixed mitral regurgitation (mr) and frayed tissue for a mitraclip procedure.Both clips passed establish final arm angle (efaa) during prep.The first xtw clip [lot 40220r1012] was placed in the middle of the valve and passed efaa before lock line removal, at a 20 degree arm angle.The lock line was removed and efaa was checked.While going to neutral with the arm positioner, the clip relaxed about 10 degrees during efaa.The clip continued to open.The arm positioner was tightened down and the clip was deployed with grade >1 mr.After deployment the the mr was grade 3+ and the clip opened to about 30 degrees.The second clip, an nt, was unable to grasp due to frayed tissue.Eventually, one grasp was achieved, but there was too much residual mr.The nt was exchanged for an xt as the second clip.The xt clip achieved a grasp medially on the valve and the deployment sequence was started.Both efaas were successful and the clip arm angle was 20 degrees.During delivery catheter shaft detachment, as the arm positioner was turned to expose the release pin groove, the clip began to open.After deployment, the clip arm angle was about 35 degrees.The mr was reduced to grade 3-4.Both clips remained stable.There was no clinically significant delay or adverse patient effect.

Manufacturer Narrative

Corrected information: h6 health effect - clinical code: code 4582 removed.Corrected information: h6 health effect - impact code: code 2199 removed.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.Attachment medwatch report #(b)(4).

Event Description

Subsequent to the initial report.It was reported that a patient presented with grade 4 mixed mitral regurgitation (mr), leaflet length of 8mm, and poor leaflet integrity for a mitraclip procedure.Both clips passed establish final arm angle (efaa) during prep.The first xtw clip [lot 40220r1012] was placed on a2/p2 (anterior and posterior 2) segments and passed efaa before lock line removal, at a 20-degree arm angle.There was no residual mr, and the mean mitral pressure gradient was 3mmhg.The lock line was removed and efaa was checked.While going to neutral with the arm positioner, the clip relaxed about 10 degrees.The clip continued to open.The arm positioner was tightened down, and the clip was deployed with grade >1 mr.After deployment, the mr was grade 3+ and the clip opened to about 30 degrees.A partial flail chord was noted.The second clip, an nt, was unable to grasp due to frayed tissue from the xtw opening.Eventually, one grasp was achieved, but there was too much residual mr.The partial flail chord had worsened due to poor tissue integrity and the additional grasps.The nt was exchanged for an xt [40219r1068] as the second clip.The xt clip achieved a grasp medially on the valve and the deployment sequence was started.Both efaas were successful, and the clip arm angle was 20 degrees.During delivery catheter shaft detachment, as the arm positioner was turned to expose the release pin groove, the clip began to open.After deployment, the clip arm angle was about 35 degrees.The mr was reduced to grade 3-4.Both clips remained stable.There remained a residual flail segment in between the 2 implanted clips with eccentric mr.At this point, given the tissue integrity, the decision was made to stop here and consider surgical intervention versus plugging on a later date.Given the hemodynamic support (vasopressors) that the patient required while intubated and sedated, and the hemodynamic decline starting from the first clip opening, and progressing from tissue injury and inability to adequately reduce mr from subsequent clips, a balloon pump was placed via the left femoral artery.No additional information was provided.

• 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: 19210221
• MDR Text Key: 341364087
• Report Number: 2135147-2024-01901
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 05415067037381
• UDI-Public: (01)05415067037381(17)250218(10)40220R1012
• 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: 04/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CDS0706-XTW
• Device Lot Number: 40220R1012
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/04/2024
• Initial Date FDA Received: 04/29/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/20/2024
• 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: 80 YR
• Patient Sex: Female