MAUDE Adverse Event Report: ABBOTT VASCULAR MITRACLIP® SYSTEM CLIP DELIVERY SYSTEM; VALVE REPAIR

Catalog Number CDS0601-NTR

Device Problems Difficult or Delayed Positioning (1157); Incomplete Coaptation (2507)

Patient Problem Atrial Tachycardia (1731)

Event Date 08/23/2019

Event Type  malfunction  

Manufacturer Narrative

Exemption number (b)(4).The clip remains in the patient anatomy.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

This is filed to report post procedure, a single leaflet detachment occurred.It was reported that the mitraclip procedure was performed on (b)(6) 2019 to treat degenerative mitral regurgitation (mr) with grade of 3-4.Two clips were implanted reducing mr to 2-3.The next day during follow up check up, transthoracic echocardiography (tte) was performed and noted that the most lateral clip detached from the posterior leaflet and remained attached to the anterior leaflet (single leaflet device attachment/slda).The lateral portion of posterior leaflet was cleft and the clip had difficulties during grasping as the physician attempted to grasp lateral to the cleft.Additionally, there was difficulty with visualization due to annual calcification and anatomy.The patient was tachycardia during the procedure and was treated with medication.There was no tissue damage noted and mr did not increase due to the slda.There was no adverse patient effect and no clinically significant delay in the procedure.There is no intervention currently planned for the patient.No additional information was provided.

Manufacturer Narrative

Exemption number e2019001.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 this event.Additionally, a review of the complaint history identified no other similar incidents from this lot.The investigation determined the reported single leaflet device attachment (slda) appears to be related to circumstances of the procedure as it is likely that the anatomy (lateral portion of posterior leaflet was cleft).The reported poor resolution/visibility contributed to the reported difficult to position/failure to adhere or bond and the reported slda.A conclusive cause for the reported tachycardia and the relationship to the product, if any, cannot be determined.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• Brand Name: MITRACLIP® SYSTEM CLIP DELIVERY SYSTEM
• Type of Device: VALVE REPAIR
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9041902
• MDR Text Key: 169515583
• Report Number: 2024168-2019-11788
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 08717648226342
• UDI-Public: 08717648226342
• 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
• Type of Report: Initial,Followup
• Report Date: 09/20/2019

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: 03/04/2020
• Device Catalogue Number: CDS0601-NTR
• Device Lot Number: 90304U194
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/23/2019
• Initial Date FDA Received: 09/13/2019
• Supplement Dates Manufacturer Received: 09/13/2019
• Supplement Dates FDA Received: 09/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 1 IMPLANTED MITRACLIP