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

Catalog Number CDS0706-XTW

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

Patient Problem Non specific EKG/ECG Changes (1817)

Event Date 12/27/2023

Event Type  Injury  

Event Description

It was reported that a mitraclip procedure was performed to treat functional mitral regurgitation (mr) with a grade of 4, pre-existing leaflet injury and pre-existing chordal rupture.A mitraclip ntw was inserted and steered to the mitral valve without issues.However, additional maneuvers were made to gain height above the valve.Once trajectory and arm orientation were achieved, the ntw was steered in the left ventricle, just medial to the previously implanted non-abbott precision transcatheter valve repair system, and grasping was performed.However, the leaflets were unable to be grasped or captured, and difficulties visualizing the clip occurred.Therefore, the clip was removed and replaced.A mitraclip xtw was inserted and steered to the mitral valve.However, additional maneuvers were made to gain height above the valve.Once satisfactory trajectory and arm position was achieved, the xtw was steered into the left ventricle on the medial side of the previously implanted non-abbott precision transcatheter valve repair system, and grasping was performed.Two grasping attempts were made, but difficulties visualizing the clip occurred.The xtw was implanted, reducing the mr significantly.However, after deployment, the v-wave increased to 55, and a transesophageal echocardiography (tee) revealed that the clip had detached from the anterior leaflet and remained attached to the posterior leaflet (single leaflet device attachment/slda).To stabilize the slda clip, a mitraclip nt was then implanted between the previously implanted non-abbott precision transcatheter repair system and xtw device.The nt clip was steered to the valve using standard maneuvers with additional height gaining maneuvers.The clip was successfully implanted without issues.The procedure was completed with two clips implanted.The mr was reduced to a grade of 2-3.The v-waves were reduced to 29, and the pulmonary vein flow was no longer reversed.

Manufacturer Narrative

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 the reported event.Additionally, a review of the complaint history did not indicate a lot-specific product issue.All available information was investigated, and the reported difficult or delayed positioning with anatomy and slda associated with the clip detaching from the anterior leaflet appear to be due to patient conditions (challenging valve pathology due to previous leaflet injury sustained during the edwards pascal device implant, specifically, a ruptured chord on the anterior leaflet).Image resolution poor was related to procedural conditions associated with suboptimal imaging.Non specific ekg/ecg changes appears to be due to the slda.Unexpected medical intervention was a result of case-specific circumstances.There is no indication of a product issue with respect to manufacture, design or labeling.

• Brand Name: MITRACLIP G4 CLIP DELIVERY SYSTEM (MDR)
• 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: 18518640
• MDR Text Key: 332934088
• Report Number: 2135147-2024-00258
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 05415067037381
• UDI-Public: 05415067037381
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/16/2024

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 Catalogue Number: CDS0706-XTW
• Device Lot Number: 30913R1039
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/27/2023
• Initial Date FDA Received: 01/16/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/13/2023
• 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
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Weight: 48 KG