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

Catalog Number CDS0706-XT

Device Problem Unintended Movement (3026)

Patient Problems Low Blood Pressure/ Hypotension (1914); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/04/2024

Event Type  Injury  

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 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 [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 was no clinically significant delay or adverse patient effect.

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), 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.

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 #0300870000-2024-8031.

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 did not indicate a lot-specific quality issue.The investigation was unable to determine a cause for the reported unintended movement of clip open while locked.The reported hypotension appears to be related to procedural conditions.Hypotension is listed in the instructions for use as a known possible complication associated with the mitraclip procedures.The reported medication required and unexpected medical intervention were results of case specific circumstance as vasopressors were given and a balloon was placed.This event was further reviewed by a staff engineer clinical r&d, and the reviewer stated that ¿six (6) fluoroscopic still images were provided and reviewed.All six images were taken during active use of the second cds07-xtw (lot 40219r1068): ¿ "img_0094" the second xtw clip is attached to the delivery catheter (dc) and appears to be in a fully closed position (~10°) indicating the image was taken prior to mechanical separation; however, it cannot be confirmed at which step in the deployment process the image was taken.The first implanted xtw clip (lot 40220r1012) is located above (lateral) the second xtw in the image and appears to have a clip arm angle of ~25° - 30°.Notably, the two clips are positioned / gasped onto the valve at differing orientations.¿ "img_0095" there is a notable change in arm angle of the second xtw clip, which appears to have an arm angle of ~20° (~10° angle change compared to img_0094).The second xtw clip is still attached to the dc shaft in the image; presumably, deployment maneuvers commenced but it cannot be confirmed at which deployment step the image was taken.There is no visible change in the state / arm angle of the first xtw clip.¿ "img_0096" there is a notable change in arm angle of the second xtw clip, which appears to have an arm angle of ~30° (~20° angle change compared to img_0094).The second xtw clip is still attached to the dc shaft in the image.Per the reported incident details "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." based on these reported details, it is presumed that this image was taken during while rotating the arm positioner to expose the release pin groove.There is no visible change in the state / arm angle of the first xtw clip.¿ "img_0097", "img_0098", and "img_0099" were taken post deployment (mechanical separation) of the second xtw clip.The clip arm angle of the second xtw appears to be ~30° - 35° and the arm angle of the first xtw clip appears to be ~40° - 45°.While the clip arm angles stated in this evaluation are estimations based on visual assessment with the unaided eye and are not confirmed, it is apparent that both clips present with an arm angle beyond the fully closed position per the instructions for use.Based on the fluoro images provided, the reported cowl incidents are confirmed.¿ corrected information: h6 health effect - impact code: code 4644 was entered twice in the previous supplemental.This was corrected to 4641.

• 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: 19210237
• MDR Text Key: 341364946
• Report Number: 2135147-2024-01902
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 05415067037404
• UDI-Public: (01)05415067037404(17)250218(10)40219R1068
• 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,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 06/21/2024

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-XT
• Device Lot Number: 40219R1068
• 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
• Supplement Dates Manufacturer Received: 05/10/2024; 06/13/2024
• Supplement Dates FDA Received: 06/05/2024; 06/21/2024
• 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: MITRACLIP.; STEERABLE GUIDE CATHETER.
• Patient Outcome(s): Required Intervention
• Patient Age: 80 YR
• Patient Sex: Female