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

Catalog Number CDS0602-XTR

Device Problems Failure To Adhere Or Bond (1031); Physical Resistance (2578)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/03/2018

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 in the patient.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 post deployment.It was reported that this was a mitraclip procedure to treat mixed mitral regurgitation (mr) with a grade of 3-4.The first clip delivery system (cds) was advanced to the mitral valve; however, due to the low transseptal puncture, the placement of the xtr clip (80117u106) in a2/p2 was challenging.The xtr clip was implanted, reducing mr to 1.After deployment, clip mobility was noted.The physician wanted to implant an additional clip for stabilization, but there was not enough space to navigate an additional clip; therefore, no treatment was performed and the procedure was discontinued.Although there was clip movement, there was sufficient leaflet capture and mr remained at 1.There was no adverse patient effect and no 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.Additionally, a review of the complaint history identified no similar incidents reported from this lot.All available information was investigated and a definitive cause for the reported failure to adhere or bond (partial clip movement) in this incident could not be determined.The reported, physical resistance appears to be due to user technique/procedural circumstances as the transseptal puncture was low.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• Brand Name: MITRACLIP XTR DELIVERY SYSTEM
• Type of Device: MITRACLIP DELIVERY SYSTEM
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 7546260
• MDR Text Key: 109497597
• Report Number: 2024168-2018-03938
• 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: 07/23/2018

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: 01/18/2019
• Device Catalogue Number: CDS0602-XTR
• Device Lot Number: 80117U106
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/03/2018
• Initial Date FDA Received: 05/25/2018
• Supplement Dates Manufacturer Received: 07/16/2018
• Supplement Dates FDA Received: 07/23/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: STEERABLE GUIDE CATHETER