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); Improper or Incorrect Procedure or Method (2017); Device Damaged by Another Device (2915)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/11/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.(b)(4).The customer reported the clip delivery system was discarded.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.The implanted clip (70926u104) is filed under a separate medwatch report number.

Event Description

This is filed to report that the clip delivery system (cds 70926u105) caused damage to the implanted clip.It was reported that this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 4.There was a flail gap of 10-12mm.One clip (70926u104) was implanted and the mr was reduced to 3.The second clip delivery system (cds 70926u105) was advanced to the mitral vaained attached to the anterior leaflet (slda).The posterior leaflet was torn and the mr returned to 4.The second clip was attempted to be placed for stabilization, but grasping was difficult.The leaflets were grasped, but the leaflet insertion was not sufficient and there was no mr reduction; therefore, the second clip was not implanted and the cds was removed.The mr remained at 4.The procedure was discontinued.On (b)(6) 2018, the patient died due to a combination of mr, aortic valve stenosis, heart failure and infection (patient was in cardiogenic shock).In the physicians opinion, due to the severe status of the patient, the mitraclip procedure was the last chance for the patient to live longer than 3-6 months.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.Additionally, a review of the complaint history did not indicate a lot-specific quality issue.The mitraclip system instructions for use (ifu) states that leaflet flail gap equal to or greater than 10 mm and/or leaflet flail width equal to or greater than 15 mm is one of the anatomic considerations may result in suboptimal leaflet insertion and/or mitraclip nt implantation.This indicated that the improper or incorrect method contributed to the failure to adhere or bond and that the user technique contributed to the device causing damage and interaction between in-use clip and previously implanted clip.All available information was investigated and the reported device damaged another device appears to be related to user technique.The reported failure to adhere or bond (leaflet grasping and captured clip not implanted) appears to be related to improper or incorrect method and patient morphology/pathology.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: 7242725
• MDR Text Key: 99785937
• Report Number: 2024168-2018-00829
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 05/04/2018

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: 09/26/2018
• Device Catalogue Number: CDS0502
• Device Lot Number: 70926U105
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/12/2018
• Initial Date FDA Received: 02/05/2018
• Supplement Dates Manufacturer Received: 04/30/2018
• Supplement Dates FDA Received: 05/04/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2017
• 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