MAUDE Adverse Event Report: ABBOTT VASCULAR MITRACLIP G4 CLIP DELIVERY SYSTEM; MITRAL VALVE REPAIR DEVICES

Model Number CDS0701-XTW

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

Patient Problem Mitral Valve Insufficiency/ Regurgitation (4451)

Event Date 12/08/2021

Event Type  Injury  

Event Description

This is filed to report single leaflet device attachment and recurrent mitral regurgitation.It was reported that on (b)(6) 2021, a mitraclip procedure was performed to treat functional mitral regurgitation (mr) with a grade of 4.The patient had a restricted posterior leaflet, tethered leaflets and a history of coronary artery disease.An xtw was inserted, and grasping was performed.It was noted that due to the restricted posterior leaflet, grasping was challenging.The clip was able to be deployed on the mitral valve and mr was reduced to a grade of 1-2.The following day, echocardiography showed the clip had detached from the posterior leaflet and remained attached to the anterior leaflet (single leaflet device attachment/slda), causing mr to increase to a grade of 3+.On (b)(6) 2021, a second mitraclip procedure was performed to stabilize the slda.One clip was implanted, reducing mr to a grade of 1-2.No additional information was provided.

Manufacturer Narrative

The clip remains in the patient.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.

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.Additionally, a review of the complaint history identified no similar complaints reported from this lot.Based on available information, a cause for the reported difficult or delayed positioning is due to patient anatomy.Moreover, the cause for the reported incomplete coaptation appears to be due to patient anatomy.Additionally, the reported recurrent mitral regurgitation (mr) appears to be cascading effects of incomplete coaptation.Mr is listed in the instructions for use as a known possible complication associated with mitraclip procedures.The reported hospitalization and medical intervention are the results of case-specific circumstances.There is no indication of product issue with respect to manufacture, design, or labeling.

• Brand Name: MITRACLIP G4 CLIP DELIVERY SYSTEM
• Type of Device: MITRAL VALVE REPAIR DEVICES
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005070406; 3885 bohannon drive; menlo park CA 94025
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 13098045
• MDR Text Key: 285403923
• Report Number: 2024168-2021-12227
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 08717648231001
• UDI-Public: 08717648231001
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/08/2022

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: 08/15/2022
• Device Model Number: CDS0701-XTW
• Device Catalogue Number: CDS0701-XTW
• Device Lot Number: 10811R257
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/08/2021
• Initial Date FDA Received: 12/28/2021
• Supplement Dates Manufacturer Received: 02/02/2022
• Supplement Dates FDA Received: 02/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/16/2021
• 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; Hospitalization
• Patient Age: 83 YR
• Patient Sex: Female