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

Catalog Number CDS0501

Device Problem Failure To Adhere Or Bond (1031)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/03/2018

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.The clip remains in the patient the clip delivery system was discarded.Investigation is not yet complete.A follow up report will be submitted with all relevant information.

Event Description

This is being filed to report that post clip implantation, there was clip movement.It was reported that this was a mitraclip procedure performed to treat mixed mitral regurgitation (mr) with an mr grade of 4+.The mitraclip delivery system (cds) was advanced to the mitral valve.Grasping the leaflets was difficult due to the fact that the operator was new.The leaflets were able to be grasped successfully; reducing mr to 2-2+.However, during clip deployment, the cds was retracted too far from the steerable guide catheter (sgc) and the gripper line could no longer be seen.The cds was removed from the sgc and the gripper line was visible now and was removed too quickly by hand; causing clip movement.The clip remained secure on both leaflets, however mr increased to 3.A second clip was implanted to further reduce mr and to ensure the clip remained stable.There was no further mr reduction; mr remained at 3.The patient is stable.No additional information was provided.

Manufacturer Narrative

(b)(4) captures the gripper line being pulled too quickly.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 identified no similar incidents reported from this lot.All available information was investigated and the reported failure to adhere or bond to the leaflets associated with partial clip movement and difficulty grasping appears to be due to the new operator (user error), not due to the device or anatomy.It should be noted that the mitraclip instructions for use under the clip deployment, warning it states: pulling the gripper line too quickly or with excessive force may raise the grippers, resulting in device damage and/or compromise leaflet capture and insertion.The information suggests that the user technique contributed to the reported failure to adhere or bond (partial clip movement and difficulty grasping).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: 7219949
• MDR Text Key: 98251733
• Report Number: 2024168-2018-00601
• 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: 04/20/2018

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: 07/17/2018
• Device Catalogue Number: CDS0501
• Device Lot Number: 70714U252
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/03/2018
• Initial Date FDA Received: 01/25/2018
• Supplement Dates Manufacturer Received: 04/17/2018
• Supplement Dates FDA Received: 04/20/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2017
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 88 YR
• Patient Weight: 77