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); Difficult To Position (1467); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/04/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Indication for use (used for tricuspid valve) 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 clip deployment.It was reported that this was a mitraclip procedure to treat functional tricuspid regurgitation (tr) with a grade of 4.Two clips were implanted.The third clip delivery system (cds) was advanced to the mitral valve and deployment steps were started.After the actuator knob was retracted.5cm, the cds handle would not retract, and the clip did not release from the system.Troubleshooting was performed by pulling the stabilizer back to realign the cds, and the clip released successfully.After retracting the cds handle successfully, the clip appeared to change position.Three clips were implanted, reducing the mr to 2.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

(b)(4).The device was returned and investigated.The reported retraction problem was not confirmed.The reported difficult to deploy clip could not be replicated in a testing environment as the coupler was unable to be exposed distally from the dc shaft and 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 did not indicate a lot-specific quality issue.The mitraclip instructions for use states under the intended use section that the mitraclip system is intended for reconstruction of the insufficient mitral valve through tissue approximation.All available information was investigated and a definitive cause for the reported difficulty to deploy the clip, retraction problem and failure to adhere or bond could not be determined.Based on the information reviewed, there is no indication of a product quality issue with respect to design, manufacture 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: 7135197
• MDR Text Key: 96044162
• Report Number: 2024168-2017-09988
• 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: 03/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/15/2018
• Device Catalogue Number: CDS0501
• Device Lot Number: 70914U192
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/04/2017
• Initial Date FDA Received: 12/20/2017
• Supplement Dates Manufacturer Received: 03/08/2018
• Supplement Dates FDA Received: 03/14/2018
• 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