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

Catalog Number CDS0705-XTW

Device Problem Positioning Failure (1158)

Patient Problems Mitral Valve Insufficiency/ Regurgitation (4451); Unspecified Tissue Injury (4559)

Event Date 03/26/2024

Event Type  Injury  

Event Description

It was reported that on 26mar2024 a patient with severe functional mitral regurgitation (mr), thin leaflets, restricted anterior and posterior leaflets, and indentation between posterior leaflet segment 2-1 was selected for a mitraclip procedure.All devices were prepared as per instructions for use (ifu).The first xtw was implanted central on anterior and posterior leaflet segment 2 (a2p2) without issue.Residual mr was observed on the lateral side of the first clip after deployment.Another xtw was thus prepared.There were attempts to implant the xtw in the lateral part of a2p2, but the patient's anatomy made it difficult (limited tissue left).The implanter opted for grasping more lateral.After 3 attempts at grasping, both leaflets succeeded to be grasped, but the posterior leaflet subsequently teared before deployment.The clip was thus inverted and retracted back in the left atrium, fully recaptured without issue, and removed from the patient.Residual mr was severe.There was no clinically significant delay.The patient will undergo a mitral valve surgery in the next following days.On (b)(6), mitral valve surgery was performed.

Manufacturer Narrative

The device will not be returned for evaluation as the device was reportedly discarded.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 the reported positioning failure associated with leaflet grasping and capture per the account was related to patient conditions (limited tissue left).Unspecified tissue injury (posterior leaflet tear) resulting in unchanged mitral valve insufficiency/regurgitation (mr) appears to be related to patient conditions (thin leaflets) and procedural conditions associated with leaflet grasping and capture related issue.Tissue damage and mitral regurgitation are known possible complications associated with mitraclip procedures.Surgical intervention and hospitalization 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: 19146332
• MDR Text Key: 340673350
• Report Number: 2135147-2024-01777
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 08717648288647
• UDI-Public: (01)08717648288647(17)250127(10)40129R1030
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 05/08/2024

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: CDS0705-XTW
• Device Lot Number: 40129R1030
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/19/2024
• Supplement Dates Manufacturer Received: 04/23/2024
• Supplement Dates FDA Received: 05/08/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/29/2024
• 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; STEERABLE GUIDE CATHETER
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 81 YR
• Patient Sex: Male
• Patient Weight: 86 KG