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

Catalog Number CDS0702-NTW

Device Problems Positioning Failure (1158); Unstable (1667); Material Split, Cut or Torn (4008)

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

Event Date 08/23/2023

Event Type  malfunction  

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.

Event Description

This is filed to report torn material.It was reported that a mitraclip procedure was performed to treat functional mitral regurgitation (mr) grade 3-4.It was noted that after advancing the first clip, the clip would not bend due to the m/l knob rotating freely.Subsequently the clip was removed and exchanged.The procedure was completed with 2 clips implanted and an mr reduction to grade 1.There was no clinically significant delay in the procedure and no adverse patient sequelae.The returned device analysis reported the lumen was observed to be torn at the distal side.No additional information was provided.

Manufacturer Narrative

All available information was investigated, and the reported unable to curve and unstable knob were confirmed via returned device analysis.Additionally, a broken m-cable and torn skive area were observed.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 unstable knob and unable to curve were cascading events of the observed broken m-cable.The cause of the observed torn skive area was unable to be determined.An exception was initiated for this incident to further investigate the observed broken m-cable.The investigation evaluated the reported issue, and the engineering group found the investigation to be inconclusive.A potential root cause though not confirmed was determined to be method.The issue 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: 17836203
• MDR Text Key: 324504901
• Report Number: 2135147-2023-04229
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 01/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/06/2024
• Device Catalogue Number: CDS0702-NTW
• Device Lot Number: 30308R1118
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/25/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/08/2023
• 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