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

Catalog Number CDS0702-XT

Device Problems Unstable (1667); Difficult to Open or Close (2921); Unintended Movement (3026)

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

Event Date 05/11/2023

Event Type  malfunction  

Event Description

This is filed to report unstable arm positioner and inability to close a clip.It was reported that a mitraclip procedure was performed to treat functional mitral regurgitation (mr) with grade 4, enlarged atrium, restricted posterior leaflet, restricted anterior leaflet, dilated non-compacted cardiomyopathy, and 23% left-ventricular-ejection-fraction (lvef).A mitraclip xtw was implanted at a2p2 without issue.The mr was reduced to grade 2-3.A mitraclip xt was placed medially to the first clip, but while closing the clip, and while returning the arm positioner to neutral position, the movement felt free or lighter than usual.The clip was inserted into the left atrium (la), but the clip would not close when turning the arm positioner.Several attempts were tried to lock and unlock, open and close.The clip opened further and further, and arm positioner felt like it was moving within neutral while turning the arm positioner.The clip was removed from the patient.Another mitraclip xt was then implanted medial to the first clip.The procedure was completed with two clips implanted.The mr was reduced to trace.There was no clinically significant delay in the procedure and no adverse patient effects.No additional information was provided.

Manufacturer Narrative

The device is expected to be returned for evaluation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.

Event Description

Subsequent to the previously filed report, additional information was received: the patient had a very dilated (greater than 50mm) heart, very dilated ventricle, a lot of tethering, dense chordae, big gap, and a pressure gradient of 1mm.The procedure was normal.There were no issues with the steerable guide catheter (sgc), and the mitraclip xtw was implanted without issues.The mitraclip xt worked as intended during preparation.The clip failed while establishing final arm angle (efaa), the lock lever had not fully advanced.The efaa was redone and it passed.The clip was deployed.Prior to diving into the ventricle, to assess trajectory, the clip was opened to 120 degrees, but the clip could not close.It was noted that it felt like it was in neutral and was non-responsive.Troubleshooting was performed but was not successful.The clip arms would open but would not close.A decision to remove the clip was made.The inverted clip crossed the septum and was retracted to the groin.Compression was required to remove the clip from the groin.No additional information was provided.

Manufacturer Narrative

All available information was investigated, and the reported unstable (arm positioner) was confirmed via device analysis.The reported difficult to open or close (clip close - inability) and unintended movement (clip open - efaa) could not be replicated in a testing environment.Additionally, it was observed the release crimper was loose in the crimping cam, and a gripper line was kinked.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 reported from this lot.Based on available information, the reported difficult to open or close (clip close - inability) associated with the inability to close the clip was due to the arm positioner instability.The reported/ observed unstable (arm positioner) associated with the loose arm positioner was due to the loose release crimper.The observed unstable (release crimper) associated with the loose release crimper was determined to be related to a potential product quality issue.The issue is being addressed per internal operating procedures.Abbott will continue to trend the performance of these devices.The cause of the reported unintended movement (clip open - efaa) associated with the clip failing the first efaa during prep appears to be due to the arm positioner not being fully advanced.The cause of the observed deformation due to compressive stress associated with the gripper line kink appears to be due circumstances during clip removal (clip withdrawn into sgc soft tip while open to remove).This event was reviewed by a staff engineer clinical r&d, and the reviewer stated ¿one (1) video taken on a personal device (e.G.Smart phone, tablet) of the fluoroscopy monitor, operator's hands, and delivery catheter (dc) handle of the reported cds was provided.The operator and dc handle are in the foreground of the video, while the fluoroscopy monitor is in the background making evaluation of the device on fluoroscopy difficult as only general, blurry shapes can be discerned in the video rather than discreet components.In the fluoroscopy monitor, the cds is inserted within the sgc and the dc catheter is partially extended.The clip is attached to the dc shaft and the clip arms appear to be in the inverted state, which aligns with the reported incident details that "the inverted clip [was] partially inserted in the catheter [for removal]".On the dc handle the clip is in the unlocked state with the lock lever retracted slightly past the blue line.The operator is actively manipulating the arm positioner, initially rotating in the closed direction at the 00:00 mark, rotating ~1 full turn and then quickly rotates back/forth which is the maneuver used to check if the arm positioner is in the neutral position such that no resistance is felt.Based on the maneuvering in the video, it appears that there is no resistance on the arm positioner even after 1 turn in the closed direction which presents as abnormal.Normally, when the arm positioner is rotated in the closed direction from the neutral state, resistance is expected as the internal actuator assembly is actively tensioned to close the clip.As the video progresses, the user continues to rotate the arm positioner in the closed direction until the slider reaches the travel limit within the arm positioner.The video demonstrates two notable device issues / abnormalities: 1.) no apparent tension in the arm positioner when rotated at least 1 turn in the closed direction where resistance is normal / expected 2.) the clip arms, as observed in the fluoroscopy monitor, remain static and do not move with the corresponding arm positioner rotations.These observations present as a potential issue with the internal actuator assembly; however, no other details or observations regarding the state of the reported device can be made based on the video.¿ based on available information, the reported difficult to open or close (clip close - inability) associated with the inability to close the clip was due to the arm positioner instability.The reported/ observed unstable (arm positioner) associated with the loose arm positioner was due to the loose release crimper.The observed unstable (release crimper) associated with the loose release crimper was determined to be related to a potential product quality issue.Therefore, exception (issue) 129004 was initiated on (b)(6) 2023 for further investigation.The cause of the reported unintended movement (clip open - efaa) associated with the clip failing the first efaa during prep appears to be due to the arm positioner not being fully advanced.The cause of the observed deformation due to compressive stress associated with the gripper line kink appears to be due circumstances during clip removal (clip withdrawn into sgc soft tip while open to remove).

• Brand Name: MITRACLIP G4 CLIP DELIVERY SYSTEM (MDD)
• 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: 17062304
• MDR Text Key: 317219351
• Report Number: 2135147-2023-02439
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: P100009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/11/2023
• Device Catalogue Number: CDS0702-XT
• Device Lot Number: 20512R106
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/12/2022
• 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: 1 IMPLANTED MITRACLIP; STEERABLE GUIDE CATHETER
• Patient Age: 74 YR
• Patient Sex: Male