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

Model Number CDS0701-NTW

Device Problems Incomplete Coaptation (2507); Unintended Movement (3026)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/05/2021

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.Na.

Event Description

This is filed to report unintended movement, single leaflet device attachment/slda and medical intervention.It was reported that this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 4+.It was noted a hyper mobile anterior leaflet.The clip delivery system (cds) was advanced to the mitral valve, and the clip was placed.However, upon release, tension was felt with the clip.The clip torqued to the anterior direction which caused the clip to become detached from the posterior leaflet but remain attached to the anterior leaflet (single leaflet device attachment/slda).Two additional clips were deployed on the lateral and medial side of the clip to stabilize the slda.Three clips were implanted, reducing mr to 2.There were no adverse patient effects and no clinically significant delay in the procedure.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 resulted in this event.Additionally, a review of the complaint history identified no other similar complaint reported from this lot.All available information was investigated, and a conclusive cause for unintended movement could not be determined in this complaint.The reported single leaflet device attachment/slda was a cascading effect of the unintended movement due to the torqueing/tension on clip causing posterior leaflet detachment.The reported additional therapy/non-surgical treatment appears to be due to case specific circumstances.There is no indication of a product issue with respect to manufacture, design or labeling.Na.

• 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: 11186174
• MDR Text Key: 227572678
• Report Number: 2024168-2021-00511
• 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: 02/24/2021

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: 08/19/2021
• Device Model Number: CDS0701-NTW
• Device Catalogue Number: CDS0701-NTW
• Device Lot Number: 00820U110
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/05/2021
• Initial Date FDA Received: 01/18/2021
• Supplement Dates Manufacturer Received: 02/03/2021
• Supplement Dates FDA Received: 02/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: STEERABLE GUIDE CATHETER
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR