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

Model Number CDS0601-NTR

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Dyspnea (1816); Edema (1820); Mitral Regurgitation (1964)

Event Date 02/25/2020

Event Type  Injury  

Manufacturer Narrative

Date of event is estimated date.The customer reported the device is not returning.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.

Event Description

This is being filed to report recurrent mitral regurgitation, prolonged hospitalization, and medical intervention.It was reported this was a mitraclip procedure to treat mixed mitral regurgitation (mr) of 3-4.It was noted a small cleft.On (b)(6) 2019, one clip was successfully deployed, reducing mr to 2.On an unknown date, the patient was recently admitted for a watchman evaluation with edema and dyspnea, and it was then discovered that the patient had recurrent mr.The physician stated that a pre-existing cleft was next to the clip that was avoided in the initial procedure and that mr may be originating around that area.Therefore, the exact cause of the recurrent mr could not be determined.The clip is stable on the leaflets.On (b)(6) 2020, the patient underwent a second mitral clip procedure to treat the recurrent mr grade of 3-4.One additional clip was implanted, reducing mr to 1+.There was no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

The device was not returned for analysis.A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot that would have contributed to this event.The investigation was unable to determine a conclusive cause for the recurrent mitral regurgitation (mr) and edema.The dyspnea appears to be related to the recurrent mr.The reported patient effects of mr, edema and dyspnea are listed in themitraclip ntr/xtr instructions for use as known possible complications associated with mitraclip procedures.There is no indication of a product 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: 9842882
• MDR Text Key: 184473851
• Report Number: 2024168-2020-02542
• 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: 04/06/2020

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: 06/21/2020
• Device Model Number: CDS0601-NTR
• Device Catalogue Number: CDS0601-NTR
• Device Lot Number: 90621U135
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/26/2020
• Initial Date FDA Received: 03/17/2020
• Supplement Dates Manufacturer Received: 03/30/2020
• Supplement Dates FDA Received: 04/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention