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

Catalog Number CDS0706-NT

Device Problems Positioning Failure (1158); Difficult to Remove (1528)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 03/14/2024

Event Type  Injury  

Event Description

It was reported that on (b)(6) 2024, a mitraclip procedure was performed to treat mitral regurgitation (mr).Transeptal puncture was placed high.A xtw clip (lot: 30928a1021) was implanted successfully.The remained jet was medial making maneuvering difficult however, a second nt (lot: 30831r1032) was able to attempt implant.Grasping was difficult and the device got caught and caused posterior leaflet damage.A third ntw (lot: 30607a1031) was attempted to be implanted to reduce mr and address the leaflet damage, but ultimately it was decided to not implant due to the damage caused by the second clip.The procedure ended with mr grade 3.

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 the reported event.A review of the complaint history identified no similar complaints from the lot.All information was investigated, and the reported positioning failure associated with leaflet grasping resulting in difficult to remove from the anatomy (clip becoming caught in anatomy) in attempts to grasp the leaflets appears to be related to patient conditions (presence of calcium on the annulus and under the posterior leaflet and high transseptal puncture).Unspecified tissue injury (posterior leaflet damage) appears to be related to difficulty removing the clip from anatomy and is therefore related to procedural conditions.Tissue damage/injury is listed in the instructions for use as a known possible complication associated with mitraclip procedures.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.

• 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: 19014854
• MDR Text Key: 339062376
• Report Number: 2135147-2024-01455
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 05415067037367
• UDI-Public: (01)05415067037367(17)240903(10)30831R1032
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/01/2024

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 Catalogue Number: CDS0706-NT
• Device Lot Number: 30831R1032
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/14/2024
• Initial Date FDA Received: 04/01/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/05/2023
• 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: 1 IMPLANTED MITRACLIP XTW; STEERABLE GUIDE CATHETER
• Patient Outcome(s): Required Intervention