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

Catalog Number CDS0706-XTW

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

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/23/2024

Event Type  Injury  

Event Description

It was reported that a patient presented with grade 4 functional mitral regurgitation (mr), marfan syndrome, severe tricuspid regurgitation, previous aortic mechanical valve, and no structural support to the anterior mitral leaflet (aml) (due to two primary chordal ruptures at the base of the papillary muscle), and a large prolapse for a mitraclip procedure.It was noted that the patient would eventually need surgery and these discussions were before the procedure.Imaging was challenging due to the heart being hyperdynamic.During placement of the first mtitraclip xtw, the clip was inadvertently moved by the operator and became entangled in chordae.Despite troubleshooting, the clip was unable to be freed from the chordae.This resulted in the clip being slightly off in regard to perpendicularity to the line of coaptation.The xtw was deployed medially with both leaflets well-inserted and chordae attached.The xtw came off the aml (a single leaflet device attachment (slda) to the posterior leaflet).A second clip was placed lateral to the first.There was some clip interaction, but there was no damage.Reversed to blunted veins and slight improvement in lap.Patient will come back in the next couple weeks for surgery due to grade 3 mr and severe tricuspid regurgitation.

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 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 entrapment of device (clip becoming caught in anatomy) resulting in slda appears to be related to user/procedural circumstances associated with the user inadvertently moving the device.Image resolution poor is related to patient and procedural conditions as imaging was reported to be challenging due to the heart being hyperdynamic.Unexpected medical interventions 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 (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: 18922420
• MDR Text Key: 337882730
• Report Number: 2135147-2024-01188
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 05415067037381
• UDI-Public: (01)05415067037381(17)241112(10)31113R1076
• 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: 04/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2024
• 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: 31113R1076
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/08/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/14/2023
• 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
• Patient Age: 47 YR
• Patient Sex: Male