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

Catalog Number CDS0702-NTW

Device Problems Entrapment of Device (1212); Incomplete Coaptation (2507); Expulsion (2933)

Patient Problems Foreign Body In Patient (2687); Embolism/Embolus (4438); Unspecified Tissue Injury (4559)

Event Date 02/09/2024

Event Type  Injury  

Event Description

It was reported that on (b)(6) 2024, a mitaclip procedure was performed to treat degenerative mitral regurgitation (mr).A mitral xtw (lot: ) was chosen for implantation.Three grasp attempts were performed but posterior leaflet could not be grasped or captured.Mr rose slightly, thought to be due to leaflet damage.Clip was placed in a new location successfully, reducing mr to grade 2.A ntw mitraclip (lot: 30814r3057) was then implanted lateral to the first clip.After deployment the ntw detached from the posterior leaflet but was stable on anterior leaflet.Third clip was not attempted to be implanted due to the weakness of the leaflet.After five minuties the ntw clip also detached from the anterior leaflet and embolized into the lower left pulmonary vein.A snare was advanced through the steerable guide catheter (sgc) and the clip was snared to the tip of sgc.The sgc was then pulled back to the right atrium but the clip then became stuck in the intra-atrial septum.The clip was stable at this position so it was decided to deploy.There was reportedly a clinically significant delay.Patient was reported to be stable.

Manufacturer Narrative

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

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 identified no similar complaints from the lot.All available information was investigated, and based on the information reviewed, a cause for the reported slda and ultimately expulsion (clip detaching from both the leaflets) cannot be determined.Entrapment of device appears to be related to procedural conditions and due to the way the embolized clip was being removed from the anatomy.Image resolution poor was related to procedural conditions of suboptimal imaging.Embolism and foreign body in patient appear to be related the complete clip detachment (expulsion).Unspecified tissue injury to the septal area appears to be related to procedural conditions associated with the way the clip was being removed from the anatomy.Embolism and tissue damage are listed in the instructions for use (ifu) as known possible complications associated with mitraclip procedures.Unexpected medical intervention and delay to treatment / therapy were 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 (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: 18831248
• MDR Text Key: 336851729
• Report Number: 2135147-2024-00973
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 08717648230974
• UDI-Public: (01)08717648230974(17)240813(10)30814R3057
• 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: 03/04/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: CDS0702-NTW
• Device Lot Number: 30814R3057
• 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: 08/15/2023
• 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): Required Intervention