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); Detachment Of Device Component (1104); Difficult to Remove (1528); Mechanical Jam (2983)

Patient Problem Embolism (1829)

Event Date 03/29/2018

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.The investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

This is being filed to report the difficult to remove the lock and gripper lines, and detachment of the clip.It was reported that this was a mitraclip procedure to treat mixed mitral regurgitation (mr) with a grade of 4.The clip delivery system (cds) was advanced.Imaging and grasping were difficult due to the patient anatomy.The leaflets were finally grasped and the mr was reduced to mild.The deployment sequence was started.While retracting the lock line, it became tangled.The line was able to be untangled and continued to be retracted.When the line was almost completely removed, it became stuck and could not be retracted.Troubleshooting was performed, with no success.The decision was made to continue with deployment.The gripper line was partially removed when it was noted that the clip had completely detached from both leaflets and remained on the gripper line.The clip then detached from the gripper line and was free floating in the left atrium (la).A second transseptal puncture was made and a new steerable guide catheter (sgc) was advanced in an attempt to snare the clip.The sgc was torqued, trapping the clip against the atrium wall.Another puncture was made and a snare device was used to retrieve the clip.Outside the anatomy, the clip was noted to be tangled with the gripper line.The physician commented that under fluoro, it did not appear that the clip was completely closed on the leaflets even though they thought they had good grasping.The procedure was restarted and a new cds was used.1 clip was implanted, reducing the mr to 1-2.No additional information was provided.

Manufacturer Narrative

(b)(4).Evaluation summary: the device was returned for analysis.The reported complete clip detachment (ccd), failure to adhere or bond, and poor image resolution could not be replicated in a testing environment as it was related to patient/procedural conditions, and the reported inability closing the clip could not be tested for.The reported inability to remove the lock line and complete clip detachment were confirmed.A knot was observed in the lock line.A review of the lot history record revealed no manufacturing nonconformities issued to this lot.Additionally, a review of the complaint history identified no similar incidents.The investigation determined the reported ccd, failure to adhere or bond and poor image resolution to be due to a combination of patient morphology/pathology and procedural circumstances.A definitive cause for the reported inability to close the clip however, could not be determined.The observed knot on the lock line was due to user technique/procedural conditions as the lock line getting tangled during lock line removal likely created the knot upon untangling it.The inability to remove the lock line/mechanical jam appears to be the result of the observed knot.There is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

Subsequent to the initially filed medwatch, follow up information confirmed the clip remained partially on the gripper line and was not free-floating in the anatomy.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
• 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: 7448163
• MDR Text Key: 106134017
• Report Number: 2024168-2018-02940
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 06/05/2018

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: 01/24/2019
• Device Catalogue Number: CDS0501
• Device Lot Number: 80123U291
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/10/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/29/2018
• Initial Date FDA Received: 04/20/2018
• Supplement Dates Manufacturer Received: 05/30/2018
• Supplement Dates FDA Received: 06/05/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR
• Patient Weight: 77