MAUDE Adverse Event Report: AV-TEMECULA-CT MITRACLIP SYSTEM CLIP DELIVERY SYSTEM NT; MITRACLIP DELIVERY SYSTEM

Catalog Number CDS0502

Device Problem Failure To Adhere Or Bond (1031)

Patient Problem Mitral Regurgitation (1964)

Event Date 03/06/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The clip remains implanted.Investigation is not yet complete.A follow up report will be submitted with all relevant information.

Event Description

This is filed to report the clip movement after deployment.It was reported that this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 3.After deployment of the first clip, mr grade was 2-3.After deployment of the second clip, it was noted that the mr grade went back to baseline.A new jet was observed between the two clips.It was believed that the anterior mitral leaflet was not deep enough in the clip and had counter-movement to the first clip.The final mr grade was 3.The patient remained stable.There was no reported adverse patient effect or a clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

(b)(4).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.Additionally, a review of the complaint history did not indicate a lot-specific quality issue at this time.The reported patient effect of mitral regurgitation (mr), as listed in the mitraclip system instructions for use, is a known possible complication associated with mitraclip procedures.All available information was investigated and a definitive cause for the partial clip movement on the leaflet could not be determined.The reported patient effect of unchanged mr appears to be a result of procedural conditions and due to the clip movement on the leaflet.Based on the information reviewed, there is no indication of a product quality issue with respect to design, manufacturing or labeling of the device.

Event Description

Subsequent to the initial 30-day medwatch report, the following information was received: imaging of the clip was noted to be difficult, during the procedure.No additional information was provided.

• Brand Name: MITRACLIP SYSTEM CLIP DELIVERY SYSTEM NT
• Type of Device: MITRACLIP DELIVERY SYSTEM
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 7374807
• MDR Text Key: 103686138
• Report Number: 2024168-2018-02229
• Device Sequence Number: 1
• Product Code: NKM
• 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,foreig
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 06/13/2018

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: 12/28/2018
• Device Catalogue Number: CDS0502
• Device Lot Number: 71228U121
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/06/2018
• Initial Date FDA Received: 03/27/2018
• Supplement Dates Manufacturer Received: 06/07/2018
• Supplement Dates FDA Received: 06/13/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: STEERABLE GUIDE CATHETER2ND IMPLANTED CLIP