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 Tissue Damage (2104)

Event Date 03/15/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Internal file number - (b)(4): during processing of this complaint, attempts were made to obtain complete event, patient and device information.The customer reported the clip was discarded.Investigation is not yet complete.A follow up report will be submitted with all relevant information.

Event Description

This is filed to report damage to the leaflet.It was reported that this was a mitraclip procedure to treat mitral regurgitation (mr) with a grade of 3.Two clips (lots 80119u187, 71113u257) were placed successfully.A third clip delivery system (cds 80119u188) was advanced; however, due to large calcification, it was not possible to grasp the leaflets.The cds was retracted to the left atrium (la); however, the posterior leaflet became torn (flail).The cds was removed and the procedure was discontinued.The mr remained at 3.The next day, a second procedure was performed to treat the flail with an occluder.During placement of the occluder, the first implanted clip detached from the anterior leaflet and remained attached to the posterior leaflet (single leaflet device attachment/slda).A new cds (80124u207) was advanced to the left ventricle (lv).While retracting the gripper lever, the gripper line broke.It was not possible to retract the clip into the la due to the lowered grippers; therefore, the clip was deployed.After deployment, it was confirmed that the clip was not attached to the leaflets and remained on the gripper line.The steerable guide catheter (sgc) was positioned above the detached clip, and the clip was pulled to the tip of the sgc.While retracting with the gripper line, the clip stuck on the septum.A snare was advanced, and the clip was retrieved successfully from the anatomy.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.Additionally, a review of the complaint history did not identify similar incidents reported from this lot.All available information was investigated and the reported failure to adhere or bond (grasping/capture) appears to be related to patient morphology/pathology (calcified leaflets).Additionally, the reported patient effects of tissue damage was related to procedural circumstances as the cds interacted with the posterior leaflet while retracting the device to left atrium.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.There is no indication of a product quality issue with respect to manufacture, design, or labeling.

• 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: 7399459
• MDR Text Key: 104464638
• Report Number: 2024168-2018-02487
• 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: 05/07/2018

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: 01/19/2019
• Device Catalogue Number: CDS0502
• Device Lot Number: 80119U188
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/16/2018
• Initial Date FDA Received: 04/05/2018
• Supplement Dates Manufacturer Received: 05/02/2018
• Supplement Dates FDA Received: 05/07/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2018
• 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, 2 IMPLANTED MITRACLIPS
• Patient Outcome(s): Hospitalization; Required Intervention