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 Mitral Regurgitation (1964)

Event Date 05/11/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).The mitraclip 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 clip movement during the procedure and single leaflet device attachment 1 month post procedure.It was reported that on (b)(6) 2018 a mitraclip procedure was performed for degenerative mitral regurgitation grade 3 with posterior leaflet prolapse.Mitraclip (cds 80123u161) was implanted on the posterior leaflet 2 (p2) and anterior leaflet 2 (a2) segment.Post implantation, a lot of clip movement was noted due to the prolapsed tissue.As treatment, a second mitraclip was implanted at the a3-p3 segment, stabilizing leaflet movement.The procedure was completed and mr had been reduced to <1.During the one month follow-up on (b)(6) 2018, transthoracic echocardiogram showed severe mr.Mitraclip (cds 80123u161) had detached from the posterior leaflet but remained attached to the anterior leaflet (single leaflet device attachment-slda).There was no treatment and no hospitalization.Another mitraclip procedure was scheduled, however, on (b)(6) 2018, the patient went to sleep with a fever and expired in her sleep.Per physician, the death was not related to the mitraclip device and was non-cardiac related.No additional information was 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 did not indicate a lot-specific quality issue.It should be noted that the reported patient effects of 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 the reported partial clip movement on the leaflet and the subsequent single leaflet device attachment (slda) appears to be related to the patient morphology/pathology (prolapsed posterior leaflet).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: 7635681
• MDR Text Key: 112273777
• Report Number: 2024168-2018-04984
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• Reporter Country Code: TH
• PMA/PMN Number: P100009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 09/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/23/2019
• Device Catalogue Number: CDS0501
• Device Lot Number: 80123U161
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/29/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2018
• 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): Required Intervention