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

Model Number CDS0706-XTW

Device Problems Break (1069); Off-Label Use (1494); Expulsion (2933); Mechanical Jam (2983); Unintended Movement (3026)

Patient Problems Foreign Body In Patient (2687); Embolism/Embolus (4438)

Event Date 01/19/2023

Event Type  Injury  

Event Description

This is filed to report a lock line jam, the clip embolizing and intervention.It was reported that an off-label mitraclip procedure was performed to treat functional tricuspid regurgitation (tr) grade 5 with rotated heart.Two clips were implanted with no reported issue.A third clip (21115r1086) was advanced to the anterior/septal leaflet.Establishing final arm angle (efaa) passed and then proceeded to remove the lock line.After approximately eight inches, it stopped firmly.The physician decided to leave the lock line in and pull the clip delivery system (cds) off over the lock line.The clip opened after it was most of the way out and inverted, then embolized.The first attempt to snare the clip, the grippers broke off.They were able to snare the grippers, but the rest of the clip went into the coronary sinus.They then snared the rest of the clip out of the coronary sinus, but the remaining connector went into the hepatic vein.Anther clip (21118r1020) was prepared but was not used.While preparing, the technician turned the arm positioner in the open direction while the clip was already inverted.When tested, the clip would not open.Final tr is 4.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

In this case, the reported mechanical jam (lock line ¿ inability), unintended movement (clip open-locked), expulsion (ccd) & off-label use (indication for use) could not be replicated in a testing environment due to it could be patient anatomy or procedural operational circumstances.The reported clip breaking apart during the procedure could not be confirmed, as the reported issue was due to procedural operational circumstances.It was also noted that the clip introducer, connector & harness were missing.Additionally, the l-lock tabs were scratched, the lock line had a small knot, the hinge pin is disengaged, the gripper was deformed & separated from the clip.A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, based on the similar complaint review, there is no indication of a lot-specific product quality issue.Based on the available information and return device analysis, the cause of the reported mechanical jam (lock line ¿ inability) associated with inability to remove the lock line cannot be determined.It appears that user technique (troubleshooting to remove cds over the lock line) contributed to unintended movement (clip open-locked).The reported expulsion (ccd) and clip embolism are cascading effects of the reported unintended movement (clip open-locked).The report foreign body in patient is a cascading effect of the reported expulsion (ccd).Moreover, the clip breaking appears to be due to user technique (snaring the clip from patient anatomy).The reported gripper separation from the clip, observed hinge pin disengagement, gripper deformation, missing connector & missing harness are cascading effects of the reported clip breaking.The reported scratches on l-lock tabs, missing clip introducer & knot on the lock line were likely an outcome of post procedural handling of the return device components.The reported off-label use is due to the user using mitraclip device on the tricuspid valve.There is no indication that the off-label use of the mitraclip device influenced the reported events; as such, no in-service will be sent regarding the off-label use.The reported unexpected medical intervention & removal of foreign body in patient were results of case specific circumstances.There is no indication of product issue with respect to manufacture, design, or labeling.This event was further reviewed by a staff engineer clinical r&d, and the reviewer stated that ¿four (4) fluoroscopic still images were provided.Three of the images (titled "image", "image1", and "image 4") show similar instances in which the first two implanted clips can be visualized (no reported issue) with the incident clip located just below in the images.In all three images, the clip arms are fully inverted, and it appears the clip is being actively snared with a noticeable loop device (snare) near/around the reported clip.While the grippers are a thinner metallic component and can typically be seen on fluoro, there is no evidence that the grippers are in frame of these images.This indicates the images were taken after the grippers were reportedly detached from the clip and successfully snared.The quality of the images (blurry, low resolution) makes it difficult to discern the separate clip components, but it does not appear that the clip arms are attached to the connector.This aligns with the reported incident details that "rest of the clip [was snared] out of the coronary sinus, but the remaining connector went into the hepatic vein".While it should be noted that a hinge pin disengagement from the connector likely occurred, it is evident that the disengagement was a secondary effect likely caused by the snaring of the clip.The last image ("titled "image3") shows the inverted clip arms in a similar state as shown in the first three images and being actively snared.Based on the reported incident details and cadence of events, the detachment of the clip components (gripper, clip arms, connector) are secondary effects and not indicative of a an issue with the clip assembly itself.Rather, the inability to remove the lock line was the primary effect, and subsequent troubleshooting maneuvers performed (deploy the clip and attempt to remove the cds over the lock line) contributed to a cowl event in which the clip ultimately embolized.Detachment of the grippers from the clip, and the clip arms from the connector, occurred during retrieval maneuvers with the snare, as reported.Therefore, it can be deduced that the clip assembly remained intact at the moment of embolization and snaring was the cause of the clip components detaching.It is likely that a gripper arm was captured in the snare first; removal forces applied likely pulled the grippers out from the clip.To provide additional context on how this can occur, figure 1 shows a fully assembled clip (note: the clip cover has been removed for demonstrative purposes) and figure 2 shows the gripper component removed from the clip assembly.The gripper is a single metal component that is specifically formed in the center to match the shape of the top of the connector, allowing the grippers to "sit" on top of the connector in the final assembly.The form fitting shape of the gripper component around the top of the connector provides structural support that holds the grippers in place.In addition, at the top central portion of the gripper component is a hole that allows the threaded study and coupler (when attached to the cds) pass through during use.When the clip arm angle is ~180° or less, the shaft of the threaded stud passes through the hole in the gripper, preventing detachment of the grippers altogether.If the clip is no longer attached to the cds (coupler not attached to threaded stud) and the clip arms are inverted, the threaded stud shaft is lifted out of the gripper component, as shown in figure 3.This will allow the clip arms to rotate about the hinge pins and connector, providing a window for the gripper component to be removed, as demonstrated in figure 4.Only in this very specific state can the grippers then be pulled from the clip.Even in this condition, active tension (pulling) must be applied to the gripper component only while the clip arms are in the rotated state to fully remove it from the clip.Based on the fluoro images provided, the clip arms are fully inverted, thus, allowing for the gripper component to be snared out from the clip, as reported.While the clip arms do not appear to be attached to the connector in the images, nor can the gripper component be visualized in any of the images, it is assumed the clip arms were rotated about the connector, similar to figure 4.It is likely that the user happened to snare only the gripper component, unintentionally, on the first retrieval attempt.Ultimately, this is an incredibly rare situation, requiring all the elements explained in this evaluation to occur, for this to happen.

Manufacturer Narrative

In this case, the reported mechanical jam (lock line ¿ inability), unintended movement (clip open-locked), expulsion (complete clip detachment/ ccd) & off-label use (indication for use) could not be replicated in a testing environment.The reported gripper breaking apart during the procedure could not be confirmed.It was also noted that the clip introducer, connector & harness were missing.Additionally, the l-lock tabs were scratched, the hinge pin is disengaged, the gripper was deformed & separated from the clip.During an initial inspection, the lock line was visually and tactile examined, and there was no damage or knots observed.A knot was observed on the lock line during a follow-up returned device analysis inspection and was likely inadvertently introduced during returned device 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, based on the similar complaint review, there is no indication of a lot-specific product quality issue.Based on the available information and return device analysis, the cause of the reported mechanical jam (lock line ¿ inability) associated with inability to remove the lock line cannot be determined.The reported unintended movement (clip open-locked) appears be due to user technique (troubleshooting to remove cds over the lock line).The reported expulsion (ccd) and clip embolism are cascading effects of the reported unintended movement (clip open-locked).The report foreign body in patient is a cascading effect of the reported expulsion (ccd).Moreover, the cause of the reported gripper breaking cannot be determined.The reported hinge pin disengagement appears to due user technique (snaring technique).The observed gripper separation, gripper deformation, missing connector & missing harness appears to be cascading effects of the hinge pin disengagement in combination with user technique (snaring).The reported scratches on l-lock tabs & missing clip introducer were likely an outcome of post procedural handling of the return device components.The knot observed on the lock line during a follow-up returned device analysis inspection was likely inadvertently introduced during returned device analysis.The reported off-label use is due to the user using mitraclip device on the tricuspid valve.An in-service will be sent to the account regarding the off-label use and possible contribution to the reported mechanical jam.The reported medical intervention & removal of foreign body in patient were results of case specific circumstances.There is no indication of product issue with respect to manufacture, design, or labeling.This event was further reviewed by a staff engineer clinical r&d, and the reviewer stated that ¿four (4) fluoroscopic still images were provided.Three of the images (titled "image", "image1", and "image 4") show similar instances in which the first two implanted clips can be visualized (no reported issue) with the incident clip located just below in the images.In all three images, the clip arms are fully inverted, and it appears the clip is being actively snared with a noticeable loop device (snare) near/around the reported clip.While the grippers are a thinner metallic component and can typically be seen on fluoro, there is no evidence that the grippers are in frame of these images.This indicates the images were taken after the grippers were reportedly detached from the clip and successfully snared.The quality of the images (blurry, low resolution) makes it difficult to discern the separate clip components, but it does not appear that the clip arms are attached to the connector.This aligns with the reported incident details that "rest of the clip [was snared] out of the coronary sinus, but the remaining connector went into the hepatic vein".While it should be noted that a hinge pin disengagement from the connector likely occurred, it is evident that the disengagement was a secondary effect likely caused by the snaring of the clip.The last image ("titled "image3") shows the inverted clip arms in a similar state as shown in the first three images and being actively snared.Based on the reported incident details and cadence of events, the detachment of the clip components (gripper, clip arms, connector) are secondary effects and not indicative of a an issue with the clip assembly itself.Rather, the inability to remove the lock line was the primary effect, and subsequent troubleshooting maneuvers performed (deploy the clip and attempt to remove the cds over the lock line) contributed to a cowl event in which the clip ultimately embolized.Detachment of the grippers from the clip, and the clip arms from the connector, occurred during retrieval maneuvers with the snare, as reported.Therefore, it can be deduced that the clip assembly remained intact at the moment of embolization and snaring was the cause of the clip components detaching.It is likely that a gripper arm was captured in the snare first; removal forces applied likely pulled the grippers out from the clip.To provide additional context on how this can occur, figure 1 shows a fully assembled clip (note: the clip cover has been removed for demonstrative purposes) and figure 2 shows the gripper component removed from the clip assembly.The gripper is a single metal component that is specifically formed in the center to match the shape of the top of the connector, allowing the grippers to "sit" on top of the connector in the final assembly.The form fitting shape of the gripper component around the top of the connector provides structural support that holds the grippers in place.In addition, at the top central portion of the gripper component is a hole that allows the threaded study and coupler (when attached to the cds) pass through during use.When the clip arm angle is ~180° or less, the shaft of the threaded stud passes through the hole in the gripper, preventing detachment of the grippers altogether.If the clip is no longer attached to the cds (coupler not attached to threaded stud) and the clip arms are inverted, the threaded stud shaft is lifted out of the gripper component, as shown in figure 3.This will allow the clip arms to rotate about the hinge pins and connector, providing a window for the gripper component to be removed, as demonstrated in figure 4.Only in this very specific state can the grippers then be pulled from the clip.Even in this condition, active tension (pulling) must be applied to the gripper component only while the clip arms are in the rotated state to fully remove it from the clip.Based on the fluoro images provided, the clip arms are fully inverted, thus, allowing for the gripper component to be snared out from the clip, as reported.While the clip arms do not appear to be attached to the connector in the images, nor can the gripper component be visualized in any of the images, it is assumed the clip arms were rotated about the connector, similar to figure 4.It is likely that the user happened to snare only the gripper component, unintentionally, on the first retrieval attempt.Ultimately, this is an incredibly rare situation, requiring all the elements explained in this evaluation to occur, for this to happen.Updated h10 investigation.

Event Description

N/a.

• 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: 16362166
• MDR Text Key: 309382446
• Report Number: 2135147-2023-00489
• 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,Followup
• Report Date: 10/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/14/2023
• Device Model Number: CDS0706-XTW
• Device Catalogue Number: CDS0706-XTW
• Device Lot Number: 21115R1086
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/15/2022
• 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: 2 IMPLANTED MITRACLIP; STEERABLE GUIDE CATHETER
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR
• Patient Sex: Female
• Patient Weight: 59 KG