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); Incomplete Coaptation (2507)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/28/2018

Event Type  Injury  

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 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 the single leaflet device attachment (slda).It was reported that on (b)(6) 2018, the patient underwent a mitraclip procedure to treat degenerative mitral regurgitation (mr) of grade 4.Patient anatomy included a large prolapse and a flail.Some difficulty was noted grasping the first clip; however, the clip was implanted.A second clip was advanced, and difficulty was noted, due to the patient anatomy.Visualization was reported to be difficult as this was the second clip.The clip was able to grasp the leaflets and sufficient leaflet capture was noted.The clip was deployed; however, after deployment, the clip detached from the posterior leaflet, remaining attached to the anterior leaflet (slda).A third clip was then advanced, and some difficulty was noted, noted due to the patient anatomy.The clip was able to be deployed, stabilizing the detached clip and reducing mr to grade 3.Post procedure, the patient was in stable condition.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 the reported event.Additionally, a review of the complaint did not indicate a lot-specific quality issue at this time.All available information was investigated and the reported single leaflet device attachment (slda) and difficulty grasping appear to be related to patient morphology/pathology (huge prolapse and a flail).The reported poor image resolution is related to the procedural circumstances of difficulty in visualizing (as this was the second clip, it was hard to visualize if the leaflet was in the clip).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: 7444427
• MDR Text Key: 105960827
• Report Number: 2024168-2018-02912
• 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: 06/25/2018

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: 11/22/2018
• Device Catalogue Number: CDS0501
• Device Lot Number: 71122U169
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/28/2018
• Initial Date FDA Received: 04/19/2018
• Supplement Dates Manufacturer Received: 06/20/2018
• Supplement Dates FDA Received: 06/25/2018
• 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
• Treatment: STEERABLE GUIDE CATHETER
• Patient Outcome(s): Required Intervention
• Patient Age: 84 YR
• Patient Weight: 91