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); Difficult or Delayed Positioning (1157); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/27/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).The clip delivery system is expected to be returned for evaluation.It has not yet been received.A follow up report will be submitted with all additional relevant information.

Event Description

This is filed to report the difficult deployment and partial clip movement.It was reported that this was a tricuspid procedure to treat grade 4 functional tricuspid regurgitation (tr).The mis-key technique was used to access the tricuspid valve.One clip was deployed without issue.The second clip was on the leaflets and deployment was initiated, but the clip did not separate from the clip delivery system (cds).Troubleshooting steps were performed for five minutes and the clip successfully detached; however, it was noted that the orientation of the clip on the leaflet changed.It could not be determined if this was due to the difficult clip deployment/troubleshooting, or if this was the orientation the clip was going to take once detached.One additional clip was implanted, reducing tr grade to 1-2.There was no reported adverse patient effect or a clinically significant delay in the procedure.There was no additional information provided.

Manufacturer Narrative

(b)(4).Evaluation summary: all available information was investigated and the reported difficult to deploy clip could not be replicated in a testing environment as the clip was not returned.Additionally, the reported failure to adhere or bond (partial clip movement) could not be replicated in a testing environment as it was related to patient/procedural conditions (operational circumstances).A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history identified no similar incidents reported from this lot.It should be noted that the mitraclip instructions for use states that: the mitraclip system is intended for reconstruction of the insufficient mitral valve through tissue approximation.A cine of the procedure was received and reviewed by an abbott vascular clinical specialist who stated that the cines showed images of deployed clips and images of closed clips grasping leaflets while still connected to the clip delivery system.There were no cines of the clips being deployed or indications of difficult clip deployment based on the cines provided.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: 7132417
• MDR Text Key: 95311200
• Report Number: 2024168-2017-09958
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 03/16/2018

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: 09/07/2018
• Device Catalogue Number: CDS0501
• Device Lot Number: 70906U113
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/27/2017
• Initial Date FDA Received: 12/19/2017
• Supplement Dates Manufacturer Received: 03/08/2018
• Supplement Dates FDA Received: 03/16/2018
• 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