MAUDE Adverse Event Report: ABBOTT VASCULAR MITRACLIP G4 CLIP DELIVERY SYSTEM; MITRAL VALVE REPAIR DEVICES

Model Number CDS0701-NTW

Device Problems Crack (1135); Material Frayed (1262); Difficult to Open or Close (2921); Material Twisted/Bent (2981); Scratched Material (3020)

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

Event Date 09/01/2021

Event Type  malfunction  

Manufacturer Narrative

All available information was investigated, and the returned device analysis confirmed the reported difficult to open or close the clip.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.All available information was investigated and returned device analysis, a cause for the reported inability to open the clip could not be determined.The observed twisted on the l-lock tabs, scratched on the l-lock tabs, cracked on the l-lock tabs, and frayed on the lock line appear to be cascading effect of the troubleshooting.There is no indication of a product issue with respect to manufacture, design, or labeling.

Event Description

This is being filed to report the cracked l-lock tabs and frayed lock line noted on the returned device.It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 3+.The clip delivery system (cds) was advanced into the patient and the clip arms tested however they would not open.Troubleshooting was performed however the clip arms would not open therefore the cds was removed.Another clip was implanted, reducing mr to 1.There was no clinically significant delay in the procedure and no adverse patient effects.Return device analysis noted the l-lock tabs were observed to be scratched, twisted, and cracked.The lock line was noticed to be frayed.No additional information was provided.

• Brand Name: MITRACLIP G4 CLIP DELIVERY SYSTEM
• Type of Device: MITRAL VALVE REPAIR DEVICES
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 12751520
• MDR Text Key: 280127153
• Report Number: 2024168-2021-09977
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 08717648230967
• UDI-Public: 08717648230967
• Combination Product (y/n): N
• PMA/PMN Number: P100009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial
• Report Date: 11/04/2021

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: 02/19/2022
• Device Model Number: CDS0701-NTW
• Device Catalogue Number: CDS0701-NTW
• Device Lot Number: 10220R139
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2021
• Initial Date Manufacturer Received: 10/18/2021
• Initial Date FDA Received: 11/04/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/20/2021
• 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: 86 YR
• Patient Weight: 75