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

Catalog Number CDS0705-XTW

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

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

Event Date 06/09/2023

Event Type  malfunction  

Event Description

This is filed to report a gripper actuation issue and a broken gripper line it was reported that a mitraclip procedure was performed to treat degenerative mitral regurgitation (mr) with grade 3-4 and prolapsed posterior leaflet.A mitraclip xtw was used, but while the gripper was down in the left atrium, one gripper would not move.Troubleshooting was performed but was not successful.Therefore, the mitraclip xtw was removed from the patient.After removal, it was observed that one of the gripper lines was missing.Another mitraclip xtw was implanted to complete the procedure.The procedure was completed with one clip 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 has been received.However, investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.Na.

Event Description

N/a.

Manufacturer Narrative

All available information was investigated, and the reported single gripper actuation (difficult to open or close) and gripper line break were confirmed via returned device analysis.Additionally, the gripper line was observed to be bent.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 did not indicate a lot-specific product issue.Based on available information, the reported single gripper actuation issue was a cascading event of the broken gripper line.The investigation determined the broken and bent gripper line may be related to a potential product quality issue, therefore, exceptions are referenced.The investigation evaluated the reported issue, and the engineering group found the investigation to be inconclusive and did not confirm it to be related to the manufacture, design or labeling of the product, however, a potential contributing factor though not confirmed was determined to be method, due to the gripper line being inadvertently snagged on the loading hook, leading to kinks.The corrective action associated with procedure improvements is being addressed per internal operating procedures.Abbott will continue to trend the performance of these devices.

• 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: 17232683
• MDR Text Key: 318340815
• Report Number: 2135147-2023-02867
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 07/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/26/2024
• Device Catalogue Number: CDS0705-XTW
• Device Lot Number: 30227R1044
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/27/2023
• 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: 87 YR
• Patient Sex: Male