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

Model Number CDS0706-XTW

Device Problem Incomplete Coaptation (2507)

Patient Problems Atrial Fibrillation (1729); Low Blood Pressure/ Hypotension (1914); Mitral Valve Insufficiency/ Regurgitation (4451)

Event Date 06/28/2023

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 single leaflet device attachment (slda) and recurrent mitral regurgitation, requiring intervention.It was reported that a mitraclip procedure was performed to treat degenerative mitral regurgitation (mr) grade of 4 with a posterior flail.One clip was implanted with no reported issue, reducing mr to grade <1.On the next day, a single leaflet device attachment (slda) was observed.The clip had detached from the posterior leaflet and mr increased to grade 4.It was noted that the patient went into rapid atrial fibrillation and their blood pressure had dropped.There was a small amount of calcium on the tip of the posterior leaflet, which might have caused the clip to detach.Additional mitraclip procedure was performed to stabilize the slda clip.One clip was implanted with no reported issue, reducing mr to grade <1.There was no clinically significant delay in the procedure.No additional information was provided.

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.The investigation determined the reported slda appears to be related to patient morphology/pathology.The recurrent mr and subsequent atrial fibrillation and hypotension appear to be related to the slda.Mr, atrial fibrillation, and hypotension are listed in the instructions for use as known possible complications associated with the mitraclip procedures.The reported hospitalization and unexpected medical interventions were results 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: 17355570
• MDR Text Key: 319421523
• Report Number: 2135147-2023-03106
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/22/2023

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/06/2024
• Device Model Number: CDS0706-XTW
• Device Catalogue Number: CDS0706-XTW
• Device Lot Number: 30308R1102
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/28/2023
• Initial Date FDA Received: 07/19/2023
• Supplement Dates Manufacturer Received: 08/01/2023
• Supplement Dates FDA Received: 08/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/08/2023
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 81 YR
• Patient Sex: Female