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); Difficult to Open or Close (2921)

Patient Problem Tissue Damage (2104)

Event Date 03/26/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4): during processing of this complaint, attempts were made to obtain complete event, patient and device information.The device was received.Investigation is not yet complete.A follow up report will be submitted with all relevant information.The mitraclip xtr is currently not commercially available in the us; however, it is similar to a device sold in the us.The other mitraclip device is filed under a separate medwatch report.

Event Description

This is filed to report the gripper actuation issue and tissue damage.It was reported that on (b)(6) 2018, the patient underwent a mitraclip procedure, treating grade 3-4 functional mitral regurgitation (mr).Patient anatomy included thin mitral leaflets and low coaptation depth.Two xtr clips were implanted without issue.A third xtr clip delivery system ((b)(4)) was advanced and placed on the lateral part of the anterior 2/posterior 2 (a2/p2) leaflet segment, lateral to the two implanted clips.Final arm angle testing was performed and the gripper line removability testing was begun; however, it was noted that the clip was no longer attached to the anterior mitral leaflet which had ruptured.The clip was opened and attempts were made to re-grasp the leaflets, but the anterior leaflet could not be captured.The grippers were not moving together and were not going down completely.The device was removed and xtr cds ((b)(4)) was prepared and advanced.After 5 grasps, the ideal location was selected and the clip deployed, but after deployment, the clip detached from the anterior mitral leaflet (slda).It was thought that the leaflet rupture contributed to the single leaflet device attachment (slda).An additional clip was implanted lateral to the implanted clips, reducing mr to grade 2-3 and stabilizing the detached clip.No additional information was provided.

Manufacturer Narrative

(b)(4).Evaluation summary: the device was returned and investigated.The reported gripper actuation issue was not confirmed.During testing the gripper arms raised and lowered without issue.The reported failure to adhere or bond could not be replicated in a testing environment as it was related to patient/procedural conditions.A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot that would have contributed to this incident.Additionally, a review of the complaint history did not indicate a lot-specific quality issue.The reported patient effect of mitral valve injury (tissue damage), 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 reported gripper actuation issue could not be determined.The reported failure to adhere or bond appears to be related to patient morphology/pathology.The reported failure to adhere or bond resulted in the reported patient effect of tissue damage as multiple anterior leaflet grasping attempts were performed.Based on the information reviewed, there is no indication of a product quality issue with respect to design, manufacture, or labeling of the device.

• 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
• 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: 7441338
• MDR Text Key: 105848107
• Report Number: 2024168-2018-02886
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 05/24/2018

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: 12/19/2018
• Device Catalogue Number: CDS0602-XTR
• Device Lot Number: 71219U186
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/13/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/26/2018
• Initial Date FDA Received: 04/18/2018
• Supplement Dates Manufacturer Received: 05/21/2018
• Supplement Dates FDA Received: 05/24/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2017
• 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 CATHETERIMPLANTED MITRACLIPS (X2
• Patient Outcome(s): Other