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

Catalog Number CDS0702-XTW

Device Problem Incomplete Coaptation (2507)

Patient Problem Mitral Valve Insufficiency/ Regurgitation (4451)

Event Date 02/27/2024

Event Type  Injury  

Event Description

It was reported that a patient presented with grade 3-4 functional mitral regurgitation (mr), a rotated heart, and porous leaflets.The first clip [31018r1096] was implanted centrally and had very mobile leaflets.There was a remaining jet lateral to the clip.A decision was made to implant a second clip [31109r1092] to further reduce the mr.The second clip was caught in chordae at the lateral commissure, and unable to invert due to the entanglement.The second clip was implanted on anterior and posterior leaflet segment 1 (a1/p1).Perpendicularity to the line of coaptation was restricted due to the entanglement.A third clip [30515r1039] was selected to implant for stabilization and to further reduce the mr.The clip selection was revised due to a single leaflet device attachment (slda) of the second clip.The mr increased and a1 was detached.It was noted that the third clip was unable to grasp both leaflets and a larger clip size was needed.There was no contact between the third and second clip.A fourth clip [31018r1102] was selected to stabilize and reduce the mr, but was unable to grasp the porous leaflets.An slda occurred with the first clip, and a2 was detached.Per the physician, the slda was due to the porous leaflets.The mr remained unchanged.The decision was made to perform surgical intervention, as the leaflets were too porous and could not be grasped.

Manufacturer Narrative

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

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.Based on available information, the reported slda was due to patient anatomy.The reported unchanged mr was a cascading event of the reported slda.The reported patient effect of mitral regurgitation, as listed in the mitraclip system instructions for use, is a known possible complication associated with mitraclip procedures.The reported surgical intervention and hospitalization were results of case-specific circumstances.There is no indication of a product quality issue with respect to manufacture, design, or labeling.

• Brand Name: MITRACLIP G4 CLIP DELIVERY SYSTEM (MDD)
• 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: 18930875
• MDR Text Key: 338007943
• Report Number: 2135147-2024-01225
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 08717648231018
• UDI-Public: (01)08717648231018(17)241016(10)31018R1096
• 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: 04/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CDS0702-XTW
• Device Lot Number: 31018R1096
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/25/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/18/2023
• 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 (X2); MITRACLIP (X3); STEERABLE GUIDE CATHETER
• Patient Outcome(s): Required Intervention
• Patient Sex: Female