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

Model Number CDS0701-NTW

Device Problems Break (1069); Unstable (1667); Difficult to Open or Close (2921)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/16/2020

Event Type  malfunction  

Manufacturer Narrative

The device was received.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.

Event Description

This will be filed to report lock line break.It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with grade 4+.The clip delivery system (cds) was advanced but when the delivery catheter black fastener was tightened, the physician commented that excessive force had to be applied to tighten the fastener.Then, when the clip was unlocked, the clip arms had resistance opening.Therefore, the physician decided to not use the cds and replace it with a new cds.The new cds completed the procedure successfully.One clip implanted, reducing mr to 1+.There was no adverse patient effect and no clinically significant delay in the procedure.Based on the device analysis, the lock line was noted to be broken.No additional information was provided.

Manufacturer Narrative

All available information was investigated and the reported difficult to tighten delivery catheter (dc) fastener could not be confirmed, and the reported clip difficult to open could not be tested via returned device analysis.Analysis additionally identified a broken lock line and scratches on the dc handle coupler and the actuator coupler.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 no similar complaints reported from this lot.Based on the information provided a conclusive cause for the reported difficult to tighten dc fastener cannot be determined.A conclusive cause for the reported difficult to open clip cannot be determined.The observed scratches on the dc handle coupler are likely the result of advancing and retracting the clip delivery system during use.The observed actuator coupler scratches are likely the result of maneuvering the device under tension during use.Based on the information provided the observed lock line break is likely the result of troubleshooting efforts.There is no indication of a product issue with respect to manufacture, design, or labeling.

• 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: 10736582
• MDR Text Key: 213202267
• Report Number: 2024168-2020-08912
• 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,Followup
• Report Date: 12/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/04/2021
• Device Model Number: CDS0701-NTW
• Device Catalogue Number: CDS0701-NTW
• Device Lot Number: 00505U107
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2020
• Date Manufacturer Received: 11/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: STEERABLE GUIDE CATHETER
• Patient Age: 82 YR
• Patient Weight: 91