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 to Open or Close (2921)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/18/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Internal file number - (b)(4): during processing of this complaint, attempts were made to obtain complete event, patient and device information.The customer reported the clip 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 the gripper actuation issue (70713u130).It was reported that this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 4+.Visualization was difficult due to imaging.The first clip (70713u130) was advanced to the mitral valve, the clip was unable to grasp the leaflets due to the anatomy.After about 1 hour of attempting to grasp, the grippers seemed loose, when closing they were still moving.The clip was removed and was replaced.The second clip (70713u129) was advanced to the mitral valve, this clip was also unable to grasp the leaflets due to the anatomy.The clip was removed and the procedure was discontinued.No clips were implanted, mr remains 4+.There were no adverse patient effects and no clinically significant delay in the procedure.No additional treatment is planned at this time.No additional information was provided.

Manufacturer Narrative

(b)(4).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 did not indicate a lot-specific quality issue.All available information was investigated and the reported difficulty grasping the leaflets appears to be related to patient morphology/pathology (short posterior leaflet).However, a definitive cause for the reported difficult to open or close (gripper actuation issue) in this incident could not be determined.The reported poor image resolution (visualization difficulties during the procedure) is related to procedural circumstances/operational context (imaging quality).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
• MDR Report Key: 7264338
• MDR Text Key: 100128009
• Report Number: 2024168-2018-01011
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• PMA/PMN Number: P100009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 05/21/2018

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: 07/13/2018
• Device Catalogue Number: CDS0501
• Device Lot Number: 70713U130
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/18/2018
• Initial Date FDA Received: 02/12/2018
• Supplement Dates Manufacturer Received: 05/16/2018
• Supplement Dates FDA Received: 05/22/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: STEERABLE GUIDE CATHETER
• Patient Age: 87 YR
• Patient Weight: 88