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

Catalog Number CDS0502

Device Problems Failure To Adhere Or Bond (1031); Incomplete Coaptation (2507)

Patient Problem Mitral Regurgitation (1964)

Event Date 03/07/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).(b)(6).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 report is filed for partial clip movement/ potential single leaflet device attachment post deployment.It was reported that a mitraclip procedure was performed treating functional mitral regurgitation grade 4, with mildly calcified leaflets.One mitraclip was implanted without reported issue.A second mitraclip (cds 71106u144) was advanced to the mitral valve and, before implantation, the clip arms were slightly clockwise from perpendicular to the line of coaptation.This mitraclip was implanted close to the posterior 2 (p2) and posterior 1 (p1) indentation with reported sufficient leaflet capture.Post deployment, movement of the posterior leaflet was observed in some views.No treatment was provided and the mr had been reduced to grade 1-2.During a routine echocardiogram two days following, increased mr was observed.Additional imaging was performed the following day showing the second clip had possibly detached from the posterior 2 (p2) leaflet, while remaining attached to the anterior 2 (a2) leaflet (single leaflet device attachment-slda).No intervention has been performed and the patient will be medically observed.There was no additional information provided regarding this issue.

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.Additionally, a review of the complaint history identified no similar incidents reported from this lot.It should be noted that the reported patient effects of worsening mitral regurgitation (mr), as listed in the mitraclip system instructions for use (ifu), is a known possible complication associated with mitraclip procedures.All available information was investigated and a definitive cause for the reported partial clip movement on the leaflet and ingle leaflet device attachment (slda) in this incident could not be determined.It is possible to be related to patient conditions (calcified leaflets and procedural circumstances), however, this cannot be confirmed.The reported worsening mr was likely related to procedural conditions and due to the movement/detachment of the clip from the leaflet.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: 7399900
• MDR Text Key: 104522405
• Report Number: 2024168-2018-02507
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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: 06/19/2018

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: 11/06/2018
• Device Catalogue Number: CDS0502
• Device Lot Number: 71106U144
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/07/2018
• Initial Date FDA Received: 04/05/2018
• Supplement Dates Manufacturer Received: 06/05/2018
• Supplement Dates FDA Received: 06/19/2018
• 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
• Patient Outcome(s): Other
• Patient Age: 65 YR