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

Catalog Number CDS0702-XTW

Device Problems Break (1069); Positioning Failure (1158); Noise, Audible (3273); Physical Resistance/Sticking (4012)

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

Event Date 02/28/2024

Event Type  malfunction  

Manufacturer Narrative

All available information was investigated, and the reported inability to curve the distal tip with the m/l knob and cable break were confirmed, as the ¿m¿ cable was noted to be broken at the radiopaque tip ring.Additionally, it was identified that the tip was unable to straighten with the m/l knob.The reported noise could not be replicated in a testing environment.The reported physical resistance/sticking of the knob was not confirmed.A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot that would have contributed to the reported event.Additionally, a review of the complaint history did not indicate a lot-specific product issue.Based on the information provided and analysis of the returned device, a cause for the reported knob resistance could not be determined.However, the investigation determined the reported/observed m-cable break resulting in noise and positioning failure of inability to curve and straighten the tip with the m/l knob as a potential product issue.The investigation evaluated the reported issue, and the engineering group found the investigation to be inconclusive, as the investigation was unable to confirm root causes related to design, labeling, or manufacturing.However, a potential contributing factor though not confirmed was determined to be method.The issue is being addressed per internal operating procedures.Additionally, it was confirmed that the calculated occurrence risk level is within the expected rate per the risk assessment.Abbott will continue to trend the performance of these devices.

Event Description

It was reported this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 4.It was observed that the m-knob was broken and unable to curve.Therefore, the clip was removed and replaced.One clip was then successfully implanted, reducing mr to a grade of 2.There were no adverse patient effects and no clinically significant delay in the procedure.

• 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: 19137803
• MDR Text Key: 340565220
• Report Number: 2135147-2024-01743
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 08717648231018
• UDI-Public: (01)08717648231018(17)240903(10)30905R1032
• 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
• Report Date: 04/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2024
• 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: 30905R1032
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/19/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/05/2023
• 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