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

Model Number CDS0701-NTW

Device Problem Incomplete Coaptation (2507)

Patient Problem Mitral Regurgitation (1964)

Event Date 01/21/2021

Event Type  Injury  

Manufacturer Narrative

The clip remains in patient.The device will not be returned for evaluation.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

This is filed to report single leaflet device attachment/slda, and recurrent mitral regurgitation it was reported that this was a mitraclip procedure to treat mixed mitral regurgitation (mr) with a grade 4+.It was noted tethered leaflets with an anterior prolapse.On (b)(6) 2020, one clip was deployed, reducing mr to 2+.Then on (b)(6) 2021, when the patient returned for a follow up, it was discovered that the clip became detached from the anterior leaflet and remained attached to the posterior leaflet (single leaflet device attachment/slda), increasing mr to 4.Additional treatment was not performed.The patient went home and is scheduled for a second clip procedure on (b)(6) 2021.No additional information was provided.

Manufacturer Narrative

The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.A review of the complaint history identified no similar incidents reported form this lot.Based on the available information, a cause for the reported single leaflet device attachment/slda could not be determined.The reported mitral regurgitation (mr) appears to be a cascading effect of the slda.Additionally, mr is listed in the instructions for use as a known possible complication associated with mitraclip procedures.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: 11318167
• MDR Text Key: 232151964
• Report Number: 2024168-2021-01127
• 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: 03/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/24/2021
• Device Model Number: CDS0701-NTW
• Device Catalogue Number: CDS0701-NTW
• Device Lot Number: 00725U155
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/28/2021
• Initial Date FDA Received: 02/11/2021
• Supplement Dates Manufacturer Received: 02/15/2021
• Supplement Dates FDA Received: 03/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 87 YR
• Patient Weight: 79