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

Catalog Number CDS0702-XTW

Device Problems Retraction Problem (1536); Unintended Movement (3026); Physical Resistance/Sticking (4012)

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

Event Date 09/11/2023

Event Type  malfunction  

Event Description

This is filed to report unintended movement it was reported that a mitraclip procedure was performed to treat functional mitral regurgitation (mr) with grade 4 and an enlarged atrium.One clip was successfully implanted on the mitral valve.To further reduce mr, an additional clip was inserted and placed on the mitral valve.It was noted that during positioning, the physician felt resistance while advancing and retracting the delivery catheter (dc) handle.During deployment, it was observed the clip opened to approximately 30-40 degrees.The clip remained stable on the leaflets; therefore, the clip was deployed, reducing mr to a grade of 1.There was no clinically significant delay in the procedure and no adverse patient effects.No additional information was provided.

Manufacturer Narrative

The clip remains in the patient.The device will not be returned for evaluation.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.Na.

Manufacturer Narrative

All available information was investigated, and the reported dc handle resistance and retraction problem were not confirmed via 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, a review of the complaint history identified no similar complaints reported from this lot.Based on available information and the returned device analysis, the cause of the reported dc handle resistance, retraction problem, clip open while locked, and observed scratched dc handle were unable to be determined.There is no indication of a product quality issue with respect to manufacture, design, or labeling.Imaging review: two (2) photographs of a fluoroscopy monitor were provided.In both photos, the first implanted clip (no reported issue) and second cds (reported device) are in view.The first photo "(b)(6) image 1" was taken prior to deployment of the second clip (reported device) as the delivery catheter (dc) is extended and the clip is attached to the l-lock shaft.The clip orientation relative to the fluoro view is angulated such that the clip arm plane cannot be directly visualized, and the clip arms are overlapping with the l-lock shaft making clip arm angle assessment difficult.The clip arm angle appears to be ~20° - 30° based on the proximity of the clip arm tips to the l-lock shaft.The second photo "(b)(6) image 2" was taken post deployment (mechanical separation) of the second clip as the clip is fully detached from the l-lock shaft and the dc is retracted.The clip arm angle of the second clip post deployment appears to be ~45°.The angles stated in this evaluation are based on visual assessment with the naked eye and are not confirmed.It does appear there was an arm angle change ~10° - 15° post deployment (mechanical separation) of the second clip.It should be noted that there is evident misalignment between the clip and dc shaft post deployment (figure 1).Prior to deployment the clip is mechanically attached to the l-lock shaft.Both the clip and l-lock shaft are rigid components, creating full alignment between the clip and dc shaft, as demonstrated by the blue line in figure 1.Post deployment, there is clear misalignment between the clip and dc shaft, as demonstrated by the yellow and red lines in figure 1.The general position / orientation of the first implanted clip remains unchanged in both photos indicating consistent positioning of the fluoroscopy c-arm.In addition, the second cds maintains similar straddling position within the sgc.Both of these observations indicate there was no change in the fluoro view and no adjustment made to the steerable sleeve pre and post deployment photos; these actions could influence how the clip and dc positions are perceived.To this end, the post deployment misalignment in the second photo is likely an accurate observation rather than a perceived one.Based on the fluoroscopic photos provided, it is possible misaligned positioning and grasping relative to the valve resulted in excess tension at the clip, contributing to the observed clip arm opening post deployment.There are no additional observations based on the photos provided.

• 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: 17879582
• MDR Text Key: 325026676
• Report Number: 2135147-2023-04349
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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: 11/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CDS0702-XTW
• Device Lot Number: 30620R1112
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/11/2023
• Initial Date FDA Received: 10/05/2023
• Supplement Dates Manufacturer Received: 10/30/2023
• Supplement Dates FDA Received: 11/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/20/2023
• 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