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

Catalog Number CDS0502

Device Problems Knotted (1340); Difficult to Remove (1528)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/28/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The clip remains in the patient.Investigation is not yet complete.A follow up report will be submitted with all relevant information.

Event Description

This is filed to report resistance during removal of the lock line.It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 3-4.The first clip was deployed without issue.During deployment of the second clip, when removing the lock line, a little knot was observed in the line.The knot became stuck in the lock lever after about 2 cm of the line was pulled and could be seen in the transparent lock lever.The knot was caught with a little cannula and pulled back out of the lock lever, then the end with the knot was pulled and the lock line was removed without any resistance.The clip stayed in the closed position, the final arm angle was successful and the rest of the deployment went on without further incident and in accordance with the instruction for use.Final mr grade was 1.There was no reported adverse patient effect or a significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

(b)(4).The device was not returned for analysis.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.Based on the information reviewed, while the difficulty to remove the lock line appears to be the result of the reported knot, a definitive cause for how the knot formed could not be determined.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: 7445541
• MDR Text Key: 106187227
• Report Number: 2024168-2018-02920
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 06/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/09/2018
• Device Catalogue Number: CDS0502
• Device Lot Number: 71108U271
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/12/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2017
• 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