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

Catalog Number CDS0501

Device Problems Failure To Adhere Or Bond (1031); Improper or Incorrect Procedure or Method (2017); Incomplete Coaptation (2507)

Patient Problem Tricuspid Regurgitation (2112)

Event Date 01/29/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

This is filed to report the single leaflet device attachment (slda).It was reported that this was a mitraclip procedure to treat functional tricuspid regurgitation (tr) with a grade of 4, and challenging anatomy.The first clip was successfully deployed on the anterior-septal leaflets, but the tr remained at 4.The second clip delivery system (cds (b)(4)) was advanced for placement on anterior-septal leaflets; however, after several attempts, the leaflets could not be grasped.The clip position was moved to the posterior-septal leaflets.It was noted that the grasping view in transesophageal echocardiography (tee) was challenging; therefore, good transgastric views were used to orient the clip perpendicular to the line of cooptation and intracardiac echocardiography (ice) was then used to visualize the grasp.Grasping was successful and the clip was deployed.After deployment, the clip detached from the septal leaflet and remained attached to the posterior leaflet (slda).A third clip was placed close to the second clip for stabilization of the slda.Three clips were implanted, but the tr remained at 4.The patient was confirmed to be stable post 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 mitraclip nt instructions for use states that the device is indicated for reduction of mitral regurgitation.The use of the mitraclip device on the tricuspid valve did not likely influence the event.All available information was investigated and the reported failure to adhere or bond to the leaflets and single leaflet device attachment (slda) appears to be due to a combination of patient morphology/pathology (cleft like indentation in the mid-anterior leaflet, restricted septal leaflet, small posterior leaflet) and procedural circumstances of challenges associated with imaging.The reported unchanged tricuspid regurgitation was due to the combination of the patient anatomy and procedural circumstances of slda.Based on the information reviewed, there is no indication of a product quality issue with respect to design, manufacturing or labeling of the device.

• 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
• Manufacturer (Section G): MENLO PARK, CA REG# 3005070406; abbott vascular; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 7286722
• MDR Text Key: 100616447
• Report Number: 2024168-2018-01283
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P100009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 05/03/2018

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: 10/11/2018
• Device Catalogue Number: CDS0501
• Device Lot Number: 71011U115
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/29/2018
• Initial Date FDA Received: 02/21/2018
• Supplement Dates Manufacturer Received: 04/27/2018
• Supplement Dates FDA Received: 05/03/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: STEERABLE GUIDE CATHETER, 1 IMPLANTED MITRACLIP
• Patient Outcome(s): Required Intervention