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

Catalog Number CDS0706-NTW

Device Problem Incomplete Coaptation (2507)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/05/2024

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that a patient presented with grade 4 functional mitral regurgitation (mr), calcium on the posterior annulus, and normal leaflets for a mitraclip procedure.It was noted that imaging was challenging, due to shadowing from the devices in use.One ntw clip was implanted.A second ntw (30607a1082) was perpendicular to the line of coaptation and of leaflet insertion assessment (lia) was satisfactory in all views.After deployment there was a single leaflet device attachment (slda) of the 2nd ntw clip.Detachment from the posterior leaflet was noted.There was no tissue damage noted after the slda.Per the physician, the challenging imaging contributed to the slda.A third clip, an nt (30322r1071), was to be placed lateral to the slda clip for stabilization.Both leaflets were grasped at first, but then a loss of leaflet capture with the posterior leaflet occurred.The nt was unable and noted to be difficult to grasp both leaflets simultaneously and independently.The nt clip damaged the posterior leaflet (appeared tattered).An xt was used as a replacement, but both leaflets were unable to be grasped independently or simultaneously.The clip was removed and the procedure was discontinued.The patient was stable throughout and at the end, despite a prolonged procedure.There were no additional treatments for the leaflet injury or slda.

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 did not indicate a lot-specific quality issue.The investigation determined the reported poor image resolution was due to shadowing from the devices in use.The reported slda was due to the poor image resolution.The reported unexpected medical intervention was a result of case specific circumstance as an additional clip was attempted to implant to stabilize the slda clip.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 MEDICAL NORTHPOINT REG 3020950818; 1820 bastian court; westfield IN 46074
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 18987160
• MDR Text Key: 338718584
• Report Number: 2135147-2024-01362
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 05415067037435
• UDI-Public: (01)05415067037435(17)240606(10)30607A1082
• 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
• Report Date: 03/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CDS0706-NTW
• Device Lot Number: 30607A1082
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/05/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/08/2023
• 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: MITRACLIP.; STEERABLE GUIDE CATHETER.
• Patient Outcome(s): Required Intervention
• Patient Age: 82 YR
• Patient Sex: Female
• Patient Weight: 48 KG