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This is filed to report tissue damage, embolism, foreign body in patient, material separation, and difficult to open or close.It was reported this was a mitraclip procedure to treat mixed mitral regurgitation (mr) with a grade of 4.An xtw clip (30314r1007) was inserted and deployed on the mitral valve.A second clip was inserted and deployed on the leaflets.However, after deployment, it was observed the first clip had detached from the posterior leaflet and remained attached to the anterior leaflet (single leaflet device attachment/slda).To stabilize the slda, an additional xtw clip (30321r1020) was inserted and attempted to be placed medially.While in the left ventricle (lv), it was noted the physician made slight adjustments to the positioning.It was then observed the clip became caught in chordae and the clip arms were unable to open and close, resulting in a clinically significant delay in the procedure and chordal damage.Troubleshooting was performed and the clip was able to be removed from the chordae.While in the left atrium (la), the clip arms were able to close, but it was noted they were jumping while closing.The clip was attempted to be retracted into the steerable guide catheter (sgc), the clip became caught on the tip of the guide, causing the soft tip to tear.It was then observed the clip completely detached from the clip delivery system (cds) and embolized in the la.A snare was then inserted and the clip was able to be removed.It was noted that in order to remove the devices, a cut down of the groin was needed.Upon removal, it was observed the grippers were no longer attached to the clip.The physician then noticed that both grippers were attached to leaflets.It was noted the grippers looked stable; therefore, no additional attempts were made to remove them.Mr was reduce to a grade of 3.No additional information was provided.
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The reported difficult to remove-anatomy and unintended movement n/a associated with cds slipping into the left ventricle (lv) and dc shaft bending from the clip becoming caught in anatomy could not be replicated in a testing environment due to it being related to procedural / operational circumstances.The reported difficult to open or close - clip open-difficult, difficult to open or close - clip close-difficult and difficult to open or close clip jumping could not be replicated in a testing environment due to the condition of the returned device (clip was not attached to the cds and the condition of the clip).Difficult to remove- cds/sgc (clip delivery system / steerable guide catheter) could not be replicated in a testing environment due to the condition of the returned devices (clip was detached and the condition of the clip and sgc soft tip was torn).The reported material separation associated with the clip detaching from the cds and the threaded stud and l-lock tabs break however, were confirmed as the clip was returned separate in a plastic container and the l-lock tabs and the threaded stud were broken.The reported material separation of the grippers was also confirmed as the grippers were not returned with the device (component missing).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 from the lot.Based on the information provided and the analysis of the returned device, the reported difficult to remove the clip from anatomy resulting in difficult to open clip, difficult to close clip, jumpy clip and unintended movement associated with the dc shaft bending and the cds slipping into the left ventricle (lv) appears to be related to procedural conditions/user technique of positioning the device and adjustments that were made during positioning.Difficult to remove the cds (clip) from the sgc in attempts to retract the open clip inside the sgc while it was caught on the soft tip resulting in material separation of the clip from the cds and the threaded stud and l-lock tabs break appears to be related to user technique/procedural circumstances as it was reported that once the clip became caught on the sgc soft tip, it was realized that the clip arms may not have been fully closed.Additionally, as the grippers were noted to be separated after the clip had detached from the device and no grasping or gripper related issues were reported prior to that, and as the cine review confirms that the clip was opened and inverted (without any indication of the clip components breaking during inversion), indicates that the reported separation of the grippers / observed missing grippers appear to be due to procedural circumstances associated with the hinge pins separation/disengagement during attempts to retract the open clip into the sgc, and then likely getting caught on the leaflets that were already tensioned in the valve due to two previously implanted clips.Unspecified tissue injury (chordal damage) is related to procedural conditions associated with the clip becoming caught in the anatomy.The reported clip embolizing (embolism/embolus) and foreign body in patient associated with the gripper on the leaflets appear to be related to procedural conditions of the clip detaching from the cds and the hinge pins disengagement due to attempts to retract the open clip into the sgc and the clip becoming caught on the sgc (difficult to remove).The reported patient effects of tissue injury/damage and emboli, as listed in the mitraclip system instructions for use are known possible complications associated with mitraclip procedures.Unexpected medical intervention, removal of foreign body, surgical intervention and delay to treatment/therapy were a result of case-specific circumstances.There is no indication of a product issue with respect to manufacture, design, or labeling.The imaging provided by the account were further reviewed by an abbott senior staff clinical engineer.The reviewer stated that ¿three hundred fifty-seven (357) echocardiographic videos and one (1) fluoroscopic still image were provided.The fluoroscopic still image shows two fully deployed clips and a fully separated gripper component (bottom of frame) which aligns with the reported incident details that "upon removal, it was observed the grippers were no longer attached to the [third] clip".All 357 echo videos were assessed and appear to capture the course of the entire procedure, including the initial imaging assessment prior to sgc insertion.The evaluation below groups videos based on procedural cadence and which cds was in active use during the videos: ¿ 1st cds07-xtw (lot 30314r1007, reported for slda): videos taken during active use of the 1st cds were unremarkable, which align with the reported incident details that the clip was implanted without issue.The clip was initially grasped very medial in the a3/p3 location.The grasp was successfully released and the clip was re-positioned more centrally in the a2/p2 location (medial aspect).The videos taken during deployment (mechanical separation) were suboptimal and do not provide clear visualization of the clip detachment from the delivery catheter (dc); however, there does not appear to be an issue or evidence of abnormality.Post deployment videos show the clip attached and secured to both leaflets immediately post deployment.¿ 2nd cds07-unk (no reported issue): videos taken during active use of the second cds show typical positioning in the atrium and advancement into the ventricle.During these maneuvers, the first implanted clip (lot 30314r1007, reported for slda) is confirmed to be attached to both leaflets via 3d en face and intercommissural views.The second cds is retracted to grasp the leaflets and is closed to 60° per the ifu, the sequence of videos is as followed: one video shows an intercommissural view in which the first clip appears attached to both leaflets and the second clip (active use device) is closed to ~60° and the next video shows a similar intercommissural view in which there is noticeably increased mobility of the first clip, indicating an slda, and the second clip (active use device) is opened to grasping arm angle (~120°) and advanced slightly into the ventricle, presumably to release the grasp.Subsequent 3d en face views confirm the first clip experienced an slda and detached from the posterior leaflet.This confirms the reported slda of the first implanted clip (lot 30314r1007).Based on the echo videos provided, the slda of the first clip occurred during leaflet grasping with the second clip; specifically, when closing the second clip onto the leaflets.It is possible that closure of the second clip contributed to the slda of the first clip based on when the slda occurred, as confirmed by the echo videos provided; however, this cannot be definitely confirmed.The second clip was positioned laterally to the first clip and were in close proximity to each other.There was no obvious or exaggerated contact between the first and second clip.Echocardiography is an ultrasound image and does not provide crisp, detailed images.Therefore, potential contact between the first implanted clip and second clip during the described grasping maneuvers cannot be confirmed.After releasing the grasp, the second cds was re-positioned more laterally with the clip remaining in the ventricle with a more prominent space in between the first and second clips in subsequent videos.Usage of the second cds continues with no further observations and the second clip was deployed without issue.¿ 3rd cds07-xtw (lot 30321r1020, reported for chordal entanglement): videos taken during active use of the third cds show the device positioned medially to the first clip in the a3/p3 region which aligns with reported incident details.The sequence of videos during positioning of the third cds is as follows: video of 3d en face view showing the third clip above the valve in the atrium ¿ video of 3d en face view with third clip positioned below the valve in the ventricle, with the device positioned in close proximity to the posterior aspect of the annulus ¿ video of lvot & intercommissural views in which the clip is located within the valve and there is an apparent bend in the dc shaft; due to poor image quality the state of the clip and clip arm angle cannot be discerned, however, it is clear that the anterior leaflet is not grasped.Subsequent videos capturing side-by-side lvot and intercommissural views show the third clip is mal-positioned relative to the line of coaptation such that the plane of the clip arms is oriented in the medial-lateral direction of the valve (parallel to line of coaptation) rather than in the anterior-posterior direction (perpendicular to line of coaptation per ifu); the clip arms can be clearly visualized in an intercommissural view which is atypical.In addition, abrupt translational movements of the dc shaft can be observed.While the chords typically cannot be visualized on echo, the position of the clip and movements of the dc shaft indicate that the clip was caught in chords and attempts to free the clip were made.During troubleshooting attempts to free the clip from the chords, the clip was eventually re-positioned and rotated, as the clip arm plane can be visualized in the lvot view, rather than in the intercommissural view, in subsequent videos.Troubleshooting attempts to free the clip continue, in which the clip was opened to ~90° and significant movement/bending of the dc shaft can be observed; however, the clip remains sub-valvular and likely caught in the chords.As the videos progress, the clip was eventually inverted while remaining sub-valvular followed by two additional videos in which the position of the third cds appears to remain unchanged; quality of the videos is poor and it is difficult to discern the state of the device.There does not appear to be any videos that captured the moment when the clip was freed from the chords or retraction of the clip into the atrium.Rather, the videos that followed sequentially capture a bi-caval view in which the third cds can be visualized in the atrium.Notably, there are two videos in which the fully inverted clip can be seen located at the septum during retraction attempts into the sgc.In the video immediately following, the clip is no longer visible at the septum, however, the sgc soft tip is visible; presumably, this is when the clip detached from the cds.The remaining videos show the inverted clip arms in the left atrium and successful snaring/retrieval.In summary, the echo videos provided align with the reported incident details and confirm the following: ¿ slda of the first clip (lot 30314r1007) occurred during grasping attempts with the second clip (lot unk, no reported issue).¿ the third clip (lot 30321r1020) became entangled in the chords.Extensive troubleshooting was performed including significant manipulation of the dc shaft, as observed in the videos.No videos provided appeared to capture the moment the clip was freed from the chords and retracted into the left atrium.Additional videos show the inverted clip located at the septum during retraction/removal attempts.As the videos progress the clip is no longer visible at the septum near the sgc soft tip and is located in the left atrium, confirming separation of the clip from the cds; the clip was successfully snared during retrieval.Discreet clip components cannot be discerned or assessed on echo.As such, no further observations can be made regarding the state of the grippers and/or other granular clip components in the echo videos.¿.
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It was reported this was a mitraclip procedure to treat mixed mitral regurgitation (mr) with a grade of 4.An xtw clip (30314r1007) was inserted and deployed on the mitral valve.A second clip was inserted and deployed on the leaflets.However, after deployment, it was observed the first clip had detached from the posterior leaflet and remained attached to the anterior leaflet (single leaflet device attachment/slda).To stabilize the slda, an additional xtw clip (30321r1020) was inserted and attempted to be placed medially.While in the left ventricle (lv), it was noted the physician made slight adjustments to the positioning.It was then observed the clip became caught in chordae and the clip arms were unable to open and close, resulting in a clinically significant delay in the procedure and chordal damage.Troubleshooting was performed and the clip was able to be removed from the chordae.While in the left atrium (la), the clip arms were able to close, but it was noted they were jumping while closing.The clip was attempted to be retracted into the steerable guide catheter (sgc), the clip became caught on the tip of the guide, causing the soft tip to tear.It was then observed the clip completely detached from the clip delivery system (cds) and embolized in the la.A snare was then inserted and the clip was able to be removed.It was noted that in order to remove the devices, a cut down of the groin was needed.Upon removal, it was observed the grippers were no longer attached to the clip.The physician then noticed that both grippers were attached to leaflets.It was noted the grippers looked stable; therefore, no additional attempts were made to remove them.Mr was reduce to a grade of 3.No additional information was provided.
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