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All available information was investigated, and the break was confirmed via device analysis.The incomplete coaptation (periprocedure) and expulsion could not be replicated in a testing environment.Additionally, the gripper cover and clip cover were observed to be frayed, the connector was scratched, the harness was deformed, the threaded stud was bent, and a frictional element was bent.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.Based on available information, the reported mitral valve insufficiency/ regurgitation (recurrent mr) associated with mr increasing to 3-4 was due to the slda.The reported incomplete coaptation (periprocedure) associated with the slda appears to be due to the gripper breaking off.The reported/ observed break associated with the broken gripper appears to be due to procedural circumstances (tension applied to the gripper), as it was noted via analysis of echocardiograms/ fluoroscopy from the procedure that the clip¿s grasp of the anterior leaflet was sub-optimal¿causing visible tension on the clip arms and grippers.It was also noted that apparent challenging valve anatomy (short posterior leaflet, long and/ or redundant anterior leaflet) likely contributed to the sub-optimal grasp.The reported expulsion associated with the gripper detaching from the clip was due to the gripper break.The reported embolism/embolus (no treatment) and foreign body in patient (no treatment) associated with the gripper embolizing into the patient was due to the gripper not being attached to the rest of the clip.The observed deformation due to compressive stress associated with the bent actuator coupler appears to be due to procedural and post-procedural circumstances (tension applied causing an un-even load on the clip).The observed scratched material associated with the scratched connector, the observed deformation due to compressive stress associated with the deformed harness, the observed material twisted / bent associated with a bent frictional element, the observed material frayed associated with the frayed clip cover, and the observed material frayed associated with the frayed gripper cover, appear to be due to circumstances during excision of the clip from anatomy in the mitral valve replacement.The reported patient effects of embolism and mitral regurgitation, as listed in the mitraclip system instructions for use, are known possible complications associated with mitraclip procedures.The reported hospitalization and surgical intervention were results of case-specific circumstances.There is no indication of a product quality issue with respect to manufacture, design, or labeling.Cine review: a power point presentation titled "gripper_broke_fukuyama cardiovascular hospital.Pptx" which consisted of 10 slides capturing cine and photographs from the incident.All cine and photos presented were evaluated below: slide 1: header slide; no cine presented slide 2: "ct image" slide provides two (2) still ct scans labeled "before mitraclip" taken on 25-may-2023 and "after slda" taken on 12-july-2023, as indicated on the images.Both ct images capture a similar cross-section of the patient's thoracic cavity.In the ct image labeled "after slda" there is a notable artifact located posteriorly on the left side of the heart.As this ct scan was taken post implantation of the clip, it is likely that the artifact is capturing a portion of the clip; however, it cannot be confirmed which part based solely on the ct image.Slide 3: "tee during mitraclip procedure (12th july)" slide provides two (2) echocardiographic videos labeled "gripper test: aml side" and "gripper test: pml side".Both videos provide an lvot view with x-plane.The lvot view captures the anterior-posterior cross-section of the valve (short axis) and provides a front-facing view of the clip so the clip arm plane can be visualized.The lvot view is typically used during the identify gripper orientation step in the instructions for use.In the video titled "gripper test: aml side" the anterior gripper can be seen being lowered and raised which aligns with the ifu step.Similarly, in the video titled "gripper test: pml side" the posterior gripper is lowered and raised.There is no evidence of a device issue or abnormality in these videos.A comment can be made on the general positioning of the device over the valve in which the tip of the clip appears to be pointing posteriorly rather than centrally.Slide 4: "tee during mitraclip procedure (12th july)" slide provides one (1) echo video capturing an lvot view with x-plane that is labeled "after gripper down simultaneously (clip angle : 120)".In the video, the clip is below the valve with both leaflets grasped within the clip arms and both grippers have been lowered to capture the leaflets, as described in the video label.The grippers can be visualized sitting on top of the leaflets, which are demonstrating the typical "bouncing" movement on top of the clip arms after grasping.When pausing the video, it is noted that the posterior gripper arm presents with an abnormal shape.The gripper is a single metal component that is specifically formed in the center such that it sits at the top of the connector within the clip, with both gripper "arms" extending outward along the clip arms.The gripper arms are flat, with the exception of the frictional elements which are too small to be visualized on imaging.Reference figure 1 and figure 2 which provide images of a clip with pertinent components labeled as reference.During a procedure, the grippers can be visualized during grasping in an lvot view similar to the videos provided in slide 4.The grippers are lowered to capture the leaflets in which the grippers can typically be visualized on top of the leaflets.Normally, the grippers flat/straight shape is maintained similar to an example lvot view provided in figure 3.In the video provided, the posterior gripper presents with a bending shape and the gripper component, as a whole, appears to make a "z" shape.Reference figure 4 which provides a labeled snapshot from video "after gripper down simultaneously (clip angle : 120)".It should also be noted that the clip is seated below the anterior-aspect of the annulus such that majority of the anterior leaflet is located above the clip arms entirely.Due to this, the anterior leaflet is in almost a vertical position relative to the clip arms, and the angle of approach/insertion is almost 90° to the anterior clip arm which is an abnormal grasping position that can contribute to sub-optimal leaflet insertion.Furthermore, the clip is positioned very posteriorly with the tip of the posterior-facing clip arm in close proximity to the annulus.Slide 5: "tee during mitraclip procedure (12th july)" slide provides two (2) echo videos capturing an lvot view with x-plane.The videos are labeled "half close" and "full close".In both videos, the clip is grasped onto both leaflets.In the "half close" video the clip arm angle is ~90°; both leaflets can be visualized inside the clip arms.In the "full close" video the clip is fully closed to ~10° - 20°.In these videos, with the clip in closed positions, it is apparent that the grasp on the anterior leaflet is sub-optimal, with the anterior leaflet positioned completely vertical and parallel to the anterior clip arm rather than perpendicular, as demonstrated by the posterior leaflet and clip arm.Reference figure 5 which provides a labeled snapshot taken from video "full close".To this end, it can be confirmed that the clip positioning on the valve and subsequent grasp on the anterior leaflet was suboptimal prior to deployment of the clip and likely contributed to the reported slda.Slide 6: "angio during mitraclip procedure (12th july)" slide provides one (1) fluoroscopic video, labeled "after deployed", taken post deployment of the reported clip.The sgc can be visualized on the left side of the video indicating the video was taken during the procedure prior to removing the sgc.The clip presents with some movement typically observed with the cardiac cycle and appears to be stable on both leaflets.The clip arms are in a closed position (~20°) similar to what is shown in the "full close" video on slide 5.One gripper is visible and appears to be bent, reference figure 6.Based on the bent nature/shape and location of the gripper in the video it is likely the posterior gripper.Slide 7: "tee during mitraclip procedure (12th july)" slide provides one (1) echo video of an lvot view labeled "after deployed".As indicated, the video was taken post deployment of the reported clip.The clip is grasped onto both leaflets; however, movement of the anterior leaflet within the clip arm is evident and the anterior gripper can be seen moving on top of the leaflet.Similar to the echo videos in slide 5, the anterior leaflet is positioned completely vertical and parallel to the anterior clip arm and gripper.Slide 8: "tee after slda (13th july)" slide provides two (2) echo videos (no labels) of an lvot view with x-plane.In both videos, there is a clear detachment/full separated of the anterior leaflet from the clip which confirms the reported slda.The clip is attached to the posterior leaflet in both videos in which it is apparent that the patient presented with challenging valve anatomy (short posterior leaflet, long and/or redundant anterior leaflet) which likely contributed to positioning and grasping issues.Slide 9: "tee after slda (13th july)" slide provides one (1) echo video of a 3d en face view of the valve.As indicated, the video was taken 1 day post procedure.The report clip can be visualized in the video and confirmed to be only attached to the posterior leaflet, with movement of the anterior leaflet making separation from the clip evident.Slide 10: "photo during mvr operation (30th july)" slide provides two (2) photographs of the reported clip with the following statement "we cannot recognize the gripper of aml side".The left photo was taken during the reported mitral valve replacement surgery in which the clip can be visualized on the valve.It is evident that the clip is still grasped onto the a leaflet in the left photo.Based on the reported incident details and confirmed by the procedural echo videos on slide 8 and slide 9, the clip detached from the anterior leaflet and remained attached to the posterior leaflet.To this end, it can be deduced that the clip is attached to the posterior leaflet in the left photo on the slide.The right photo shows the fully excised clip.The anterior gripper is noticeably missing in both photos.Reference figure 7 and figure 8 which provided labels indicating the missing gripper in the photos.Due to the angle of the photo of the excised clip only the tip of the posterior gripper can be visualized.Addendum to original cine evaluation: additional cine for this incident was received on 13september2023.A total of 326 images / videos were provided and evaluated: ¿ two (2) ct scans of the patient were provided.One scan appears to be a full body scan and the other is a cross-section of the thorax-pelvic region.No additional information regarding the reported incident can be obtained from these scans.¿ nine (9) fluoroscopic videos were provided and assessed in sequence: the first four of the videos were taken during the transeptal puncture in which the exchange sheath, guidewires, and sgc-dilator assembly can be seen being advanced into the left atrium; no addition information regarding the reported incident can be obtained from these four videos as the report cds and clip are not present.The fluoroscopy arm in the fifth, sixth, and seventh videos is positioned such that the fluoro image is parallel to the clip arm plane; the clip arm angle and grippers cannot be directly visualized in these videos.The fifth video shows the reported cds positioned in the left atrium.The dc shaft is extended with the clip attached to the l-lock shaft.Based on the small tip-to-tip distance of the clip arms, the clip appears to be in a fully closed position.To this end, the fifth video was likely taken after grasping and closing the clip on the leaflet, but prior to deployment.The sixth video was taken during active deployment (mechanical separation) of the clip from the dc.The video begins with the clip attached to the l-lock shaft of the dc and as the video progresses the dc shaft is slowly retracted, separating from the clip.Upon separation, there is some medial movement of the l-lock shaft indicating potential misalignment during deployment; however, the movement is not abrupt or significant, and does not appear to have resulted in adverse effects.As the video continues, immediately post deployment the clip appears in a stable position.The seventh video was taken post deployment of the clip.Due to the angle of the fluoro view relative to the clip, a more granular assessment of the clip components (e.G.Grippers) cannot be conducted as they are obscured by the clip arm.There are no evident device abnormalities in the fifth, sixth, and seventh videos.The eight and ninth videos were taken post deployment and at different fluoro angles and present similarly.The ninth video is the same video captured in slide 6 of the presentation that was part of the original cine evaluation (reference slide 6 evaluation).No additional information regarding the reported incident can be obtained from these videos.¿ three hundred fifteen (315) echocardiographic videos were provided.All 315 videos were assessed and appear to capture the course of the entire procedure (initial assessment prior to sgc insertion, usage of the report cds, and post removal of cds) as well as next day post op.Assessment and includes the echo videos that were initially provided in the power point presentation and assessed in the original cine evaluation.The additional echo videos corroborate the challenge anatomy the patient presented with, noting a significant "aortic hugger" positioning situation, short posterior leaflet, and small valve size.In addition, the imaging quality was poor with low resolution, shadowing and artifacts visible in the clip region; assessing the clip components at a granular level is not possible.One video to note was taken during grasping in which the clip arms are open to ~120° in accordance with the ifu and the leaflets are grasped within the clip arms.Both leaflets can be seen "bouncing" on top of the clip arms which is typical and expected.Both grippers have been lowered and can be visualized on top of the leaflets.Based on the time stamps, this video was taken directly after the video provided on slide 4 of the power point presentation initially provided and shows the same instance during the procedure.In the original cine evaluation, the video on slide 4 presented such that the posterior gripper appeared to have an abnormal, bent shape.However, in the following video taken immediately after the entire posterior gripper can be faintly discerned during the cardiac cycle with a notable gap between the gripper and what is potentially an image artifact (reference figure 9).Based on the additional video provided, it is likely the posterior gripper was in a normal, undamaged state at the time these videos were taken (after leaflet capture, prior to clip closure).However, based on the fluoro video provided in slide 6 there is an evident bend in the posterior gripper, in which the distal portion of the gripper appears to be bending inward toward the anterior clip arm.Based on cine provided, it is possible the posterior gripper became bent at the distal portion due to the challenging anatomy and positioning, in which the posterior facing clip arm grasped in very close proximity to the annular ridge which is thicker and more ridged than leaflet tissue.Videos taken immediately post deployment align with the original cine evaluation in which the grasp of the anterior leaflet is insufficient, such that the leaflet plane (leaflet tip to annular ridge) is parallel with the clip arm and gripper; the leaflet does not contact or extend over the tip of the clip arm.In this way, movement of the anterior leaflet within the clip arm is evident and the anterior gripper can be seen moving on top of the leaflet throughout the cardiac cycle.Videos taken one day post procedure capture the slda, in which it is confirmed the clip fully detached from the anterior leaflet, as previously stated in the original cine evaluation.No additional information regarding the reported incident can be obtained from these videos.".
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