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

Catalog Number CDS0706-XTW

Device Problems Off-Label Use (1494); Difficult to Remove (1528)

Patient Problems Tricuspid Valve Insufficiency/ Regurgitation (4453); Unspecified Tissue Injury (4559)

Event Date 04/04/2024

Event Type  Injury  

Event Description

It was reported that a mitraclip procedure was performed to treat a tricuspid valve with tricuspid regurgitation (tr) grade 3 and restricted leaflet.A mitraclip xtw was inserted and advanced to the tricuspid valve.However, the clip became caught on the valve.The clip was pulled back, but it caught on the chordae and caused a tear.The physician decided to remove the mitraclip devices and discontinue the procedure.Tr increased to grade 4.There was no clinically significant delay in the procedure.

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 revealed no manufacturing nonconformities issued to the reported lot.Additionally, a review of the complaint history identified no other complaints reported from this lot.The investigation was unable to determine a cause for the reported difficult to remove of clip being caught on anatomy.The reported off-label use was due to the device being used on a tricuspid valve.The tissue injury was due to the difficult to remove (clip caught on anatomy).The worsening tr appears to be a cascading effect of the tissue injury.Tissue injury is listed instructions for use as a known possible complication associated with mitraclip procedures.The reported serious injury/illness/impairment was a result of case specific circumstance as no treatment was provided for the patient effects.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: 19206791
• MDR Text Key: 341358604
• Report Number: 2135147-2024-01892
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 05415067037381
• UDI-Public: (01)05415067037381(17)250106(10)40104R2059
• 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: 05/17/2024

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-XTW
• Device Lot Number: 40104R2059
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/04/2024
• Initial Date FDA Received: 04/29/2024
• Supplement Dates Manufacturer Received: 05/06/2024
• Supplement Dates FDA Received: 05/17/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/08/2024
• 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: STEERABLE GUIDE CATHETER
• Patient Outcome(s): Other