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

Catalog Number CDS0702-XT

Device Problems Positioning Failure (1158); Entrapment of Device (1212); Difficult to Remove (1528); Difficult to Open or Close (2921)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/08/2024

Event Type  Injury  

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 from the lot all available information was investigated and based on information provided the reported positioning failure associated with leaflet grasping appears to be related to patient conditions (rotated heart and restricted posterior leaflet).However, based on the information provided and without the device to analyze, a cause for the inability to close the clip cannot be determined.Difficult to remove the clip delivery system (cds) from the steerable guide catheter (sgc) appears to be due to the inability to fully close the clip.Entrapment of device associated with clip becoming caught in the groin appears to be related to procedural conditions associated with inability to fully close the clip and the open clip being unable to be retracted into the sgc.Foreign body in patient associated with deploying the clip at the groin appears to be due to the procedural circumstances associated with the clip becoming caught with the anatomy (groin).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.

Event Description

It was reported that on (b)(6) 2024, a mitraclip procedure was performed to treat a mixed mitral regurgitation (mr) with grade of 4, rotated heart, and restricted posterior leaflet.First clip (xtw) was implanted a2/p2.The clip was not perfectly attached and was noted to partially move from its intended location.A second clip (xt) was then attempted to be implanted to stabilize and treat residual mr, but the physicians had difficulties grasping the leaflets.The orientation was not good and therefore was not implanted.It was decided to remove the device from the anatomy.When closing the clip arms to retract the clip into the steerable guide catheter (sgc), the arms remained open 20 to 30 degrees and was not possible to fully close the arms of the clip.It was decided by the physicians to remove the devices as a single unit, but the clip got stuck at the groin.The clip was deployed and was left in the groin.On (b)(6) 2024, an additional mitraclip procedure was performed to treat mitral regurgitation (mr) of grade 4.One clip was implanted, reducing mr to grade 1.There was no clinically significant delay in the procedure.

• 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: 18607686
• MDR Text Key: 334107459
• Report Number: 2135147-2024-00404
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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
• Report Date: 01/30/2024

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 Expiration Date: 05/07/2024
• Device Catalogue Number: CDS0702-XT
• Device Lot Number: 30508R1029
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/08/2024
• Initial Date FDA Received: 01/30/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/09/2023
• 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