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); Break (1069); Detachment Of Device Component (1104); Incomplete Coaptation (2507)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/15/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).The clip delivery system was received.Investigation is not yet complete.A follow up report will be submitted with all relevant information.The steerable guide catheters (71031u103) is filed under a separate medwatch report number.

Event Description

This is filed to report the single leaflet device attachment (slda), complete clip detachment and gripper line break.It was reported that this was a mitraclip procedure to treat mixed mitral regurgitation (mr) with a grade of 4+.The steerable guide catheter (sgc 71031u103) was inserted into the anatomy; however, fluid column was lost.The sgc was removed from the anatomy and an attempt was made to flush the valve, but a large clot was noted.The clot could not be removed; therefore, the sgc was no longer used, and replaced.A new sgc was used and one clip was implanted, slightly reducing mr to 4.The second clip delivery system (cds 70925u383) was advanced to the mitral valve.Grasping and visualization were difficult.The clip was deployed, reducing mr to 2+; however, after deployment, the clip detached from the posterior leaflet and was attached to the anterior leaflet (slda).During gripper line removal, the clip completely detached from the anterior leaflet, but remained on the gripper line.The cds was taken apart, and the clip was pulled back to the tip of the sgc with the gripper line, and then the whole system was retracted to the access site.At this point, the gripper line broke.Angiography was performed and the clip was located at the access site.The clip was retrieved with hemostats and the procedure was discontinued.The patient remained hemodynamically stable throughout the procedure.No additional information was provided.

Manufacturer Narrative

(b)(4).The device was returned and investigated.The reported failure to adhere or bond, incomplete coaptation (single leaflet device attachment/slda), complete clip detachment (ccd) and poor image resolution could not be replicated in a testing environment as it was related to patient/procedural conditions.Due to the returned condition of the device (broken sleeve and delivery catheter/dc handle coupler), the reported gripper line break during removal could not be replicated in a testing environment.A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot that would have contributed to this complaint.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 gripper line break during removal could not be determined.The reported failure to adhere or bond and slda appear to be related to the reported poor visualization during the procedure.The reported ccd was a result of procedural conditions/user technique as the clip completely detached while the gripper line was attempted to be removed post slda.The observed, broken dc coupler and sleeve shaft appears to be related to procedural conditions as the devices physical condition was compromised to get access to the gripper line which was already pulled into the cds device.Based on the information reviewed, 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: 7246435
• MDR Text Key: 99182469
• Report Number: 2024168-2018-00879
• 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: 02/23/2018

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: 09/26/2018
• Device Catalogue Number: CDS0501
• Device Lot Number: 70925U383
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/05/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/15/2018
• Initial Date FDA Received: 02/06/2018
• Supplement Dates Manufacturer Received: 02/21/2018
• Supplement Dates FDA Received: 02/24/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2017
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR