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); Entrapment of Device (1212); Improper or Incorrect Procedure or Method (2017)

Patient Problem Foreign Body In Patient (2687)

Event Date 05/25/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.(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 as the mitraclip became stuck and was deployed on the anterior leaflet only.It was reported that this was a mitraclip procedure treating mixed, functional and degenerative, mitral regurgitation (mr) grade 4++.The patient presented with a restricted posterior leaflet and minor prolapse.One mitraclip was implanted without reported issue.Following, a second clip delivery system (cds 80226u214) advanced into the left ventricle with the clip arms open to 160 degrees and without checking clip arm orientation.The cds handle was sharply rotated 90 degrees while the clip arms remained open and while under the mitral valve.All these manipulations occurred quickly and before the physician could be asked to stop and invert the mitraclip back into the left atrium.This clip became stuck on the lateral side of the valve on the anterior leaflet.One grasping attempt was performed to capture the posterior leaflet at this location; however, was unsuccessful as the clip was unable to be positioned further.Standard troubleshooting measures were performed; however, after several attempts, the clip could not move back into the atrium nor further into the ventricle, therefore, the mitraclip was deployed at this location, on the anterior leaflet only.Two additional clips were implanted as treatment and to stabilize the first implanted mitraclip.The mr was reduced to grade 2.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 that would have contributed to the reported event.Additionally, a review of the complaint history identified no similar incidents reported from this lot.It should be noted that the mitraclip nt instructions for use (ifu) warns the user to not make substantial clip arm orientation adjustment in the left ventricle (lv).Clip entanglement in sub-valvular apparatus may result in cardiac injury and worsening mitral regurgitation; and may result in difficulty or inability to remove the clip, and conversion to surgical intervention.All available information was investigated, and the reported entrapment of device or device component and failure to adhere or bond appears to be due to the user error of making substantial clip arm orientation adjustments in the left ventricle.Additionally, the patient morphology/pathology (restricted posterior leaflet and a minor prolapse) may have also contributed to the difficulty grasping.The foreign body in patient appears to be a result of chordal entanglement and thus related to procedural conditions.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
• MDR Report Key: 7611195
• MDR Text Key: 111389704
• Report Number: 2024168-2018-04556
• 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: 08/15/2018

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: 02/27/2019
• Device Catalogue Number: CDS0501
• Device Lot Number: 80226U214
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/25/2018
• Initial Date FDA Received: 06/18/2018
• Supplement Dates Manufacturer Received: 08/07/2018
• Supplement Dates FDA Received: 08/15/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ONE IMPLANTED MITRACLIPSTEERABLE GUIDE CATHETER; ONE IMPLANTED MITRACLIPSTEERABLE GUIDE CATHETER
• Patient Outcome(s): Required Intervention
• Patient Age: 81 YR