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

Catalog Number CDS0702-XTW

Device Problems Break (1069); Difficult or Delayed Positioning (1157); Difficult to Open or Close (2921)

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

Event Date 02/08/2024

Event Type  malfunction  

Event Description

It was reported that a mitraclip procedure was performed to treat functional mitral regurgitation (mr) with a grade of 4, restricted posterior leaflet, prolapsed posterior leaflet, and dilated left atrium.A mitraclip xtw (30329r3008) was inserted without issues.However, difficulties with positioning the clip due to patient anatomy occurred.While in the mitral valve, after grasping attempts, it was observed that both grippers were not functioning as intended.It was noted that after the last grasping attempt, the grippers were not raised before opening the clip to invert.When the grippers were raised, the back side of the grippers interacted with the leaflets.Troubleshooting was performed, but the issue was unable to be resolved.Therefore, the clip was removed from the patient.While outside the patient, the clip system was examined and it was observed that both gripper lines were no longer inserted into the distal shaft of the catheter, leaving the grippers in the lowered position.After a new and better transseptal puncture, another mitraclip xtw (30329r3007) was inserted without issues and implanted on the mitral valve.To further reduce the mr, another mitraclip xtw (30329r3009) was advanced into the left ventricle (lv).However, while in the lv, the clip became caught in chordae.Troubleshooting was performed, but the issue was not able to be resolved.The clip could not be freed from chordae.Therefore, the clip was implanted on only one leaflet (the anterior leaflet) and chordae, where it was stuck, laterally to the first implanted clip.It was noted that there was some interaction of the first and second implanted clip, reducing the effect of the first clip.The procedure was completed with two clips implanted, reducing the mr to a grade of 3-4.It was noted that the mitraclip xtw (30329r3007) was stable on the leaflets.There was no clinically significant delay in the procedure.

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.The additional mitraclip device referenced in b5 is being filed under a separate medwatch report.

Event Description

N/a.

Manufacturer Narrative

All available information was investigated, and the reported multiple gripper actuation issue and broken gripper lines were confirmed via returned device analysis.The reported difficult positioning due to anatomy could not be replicated in a testing environment.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 reported difficult positioning was due to patient anatomy.The cause of the reported multiple gripper actuation issue and broken gripper lines were unable to be determined.There is no indication of a product quality issue with respect to manufacture, design, or labeling.

• 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: 18811694
• MDR Text Key: 336850273
• Report Number: 2135147-2024-00943
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 08717648231018
• UDI-Public: (01)08717648231018(17)240328(10)30329R3008
• Combination Product (y/n): N
• Reporter Country Code: NO
• 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: 04/22/2024

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 Expiration Date: 03/28/2024
• Device Catalogue Number: CDS0702-XTW
• Device Lot Number: 30329R3008
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/08/2024
• Initial Date FDA Received: 02/29/2024
• Supplement Dates Manufacturer Received: 04/11/2024
• Supplement Dates FDA Received: 04/22/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/30/2023
• 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: STEERABLE GUIDE CATHETER
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Weight: 73 KG
• Patient Race: White