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

Catalog Number CDS0702-NTW

Device Problems Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)

Patient Problems Mitral Valve Insufficiency/ Regurgitation (4451); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/05/2022

Event Type  Injury  

Manufacturer Narrative

Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

This is filed to report worsening mitral regurgitation and surgical intervention.It was reported that a mitraclip procedure was performed to treat mitral regurgitation (mr) grade 3.Image quality was extremely poor during the procedure, and the posterior leaflet and annulus was calcified and the free length of the posterior leaflet was about 5-7 mm long.A ntw clip ((b)(4)) grasped the valve, reducing mr to grade 1, but once the clip was deployed the mr increased to grade 2.Subsequently the physician decided to implant a second clip to further reduce the mr.A nt clip ((b)(4)) was attempted to be placed lateral to first clip.However, the first grasp did not reduce the mr enough so it was re-positioned.After several grasps were performed the mr began to worsen.It was thought damage to the posterior leaflet occurred.The clip was eventually placed successfully with a slight mr reduction, but once deployed the clip detached from the posterior leaflet and mr increased to grade 4.A third clip was prepared and inserted into the anatomy to stabilize the single leaflet device attachment (slda), but it was decided to not to attempt to place another mitraclip.The third clip was removed from the patient and the patient was transferred to heart surgery.No additional information was provided.

Manufacturer Narrative

There is nothing in the information provided that meets any part of the definition for a complaint as stated in sh 90873452.Downgraded as there was no device issue or patient effect due to ntw lot 20209r193.

Event Description

Subsequent to the previously filed report, additional information was received: the first clip had no device issue.Mr rose due to unknown reasons, requiring the physician to implant the second clip.There was no device issues or patient consequences with the third clip.

• Brand Name: MITRACLIP G4 CLIP DELIVERY SYSTEM
• Type of Device: MITRAL VALVE REPAIR DEVICES
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005070406; 3885 bohannon drive; menlo park CA 94025
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 16067030
• MDR Text Key: 306320475
• Report Number: 2135147-2022-02754
• 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: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/13/2023

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/08/2023
• Device Catalogue Number: CDS0702-NTW
• Device Lot Number: 20209R193
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/05/2022
• Initial Date FDA Received: 12/29/2022
• Supplement Dates Manufacturer Received: 01/12/2023
• Supplement Dates FDA Received: 01/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/09/2022
• 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
• Treatment: STEERABLE GUIDE CATHETER
• Patient Outcome(s): Required Intervention