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

Catalog Number CDS0702-XTW

Device Problems Difficult or Delayed Positioning (1157); Expulsion (2933)

Patient Problems Foreign Body In Patient (2687); Embolism/Embolus (4438); Mitral Valve Insufficiency/ Regurgitation (4451); Unspecified Tissue Injury (4559)

Event Date 01/10/2024

Event Type  Injury  

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 identified no similar complaints from the lot.All available information was investigated, and based on the information provided, the difficult or delayed positioning associated with leaflet grasping and capture and clip coming out of the posterior leaflet appears to be related to patient morphology/pathology (posterior flail and severely degeneratively altered leaflets).Unspecified tissue injury per the physician is due to the severely degeneratively altered anatomy.Foreign body in patient appears to be due to the procedural circumstances associated with the clip coming out of the posterior leaflet and the clip being deployed only on one leaflet.Tissue damage is listed in the mitraclip system instructions for use as a known possible complication associated with mitraclip procedures.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.

Event Description

It was reported this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 4 and a posterior flail.An xtw clip was inserted, and it was noted grasping and capturing was difficult.However, after placing the clip and establishing final arm angle (efaa) for the second time, the clip tore and came out of the posterior leaflet.It was noted there was chordal rupture.The clip remained attached and stable on the anterior leaflet and was deployed on the one leaflet.To stabilize the clip, an additional xt clip was successfully implanted, reducing mr to a grade of 2.There was no clinically significant delay in the procedure.

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 identified no similar complaints from the lot.All available information was investigated, and based on the information provided, the difficult or delayed positioning associated with leaflet grasping and capture (clip coming out of the posterior leaflet and remaining attached to the anterior leaflet only) ultimately resulting in expulsion (complete clip detachment) appears to be related to patient morphology/pathology (posterior flail and severely degeneratively altered leaflets).Unspecified tissue injuries resulting in mitral valve insufficiency/regurgitation (mr) appear to be due to the severely degeneratively altered anatomy and later due to the clip embolizing.Foreign body in patient and embolism appear to be due to the procedural circumstances associated with the clip coming out of the posterior leaflet and the clip being deployed only on one leaflet during the initial mitraclip procedure and subsequently the clip completely detaching from the leaflet and embolizing in the anatomy.Tissue damage, emboli, mitral regurgitation and foreign body in patient (dislodgement of previously implanted devices) are listed in the mitraclip system instructions for use as known possible complications associated with mitraclip procedures.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.

Event Description

Subsequent to the initially filed report, additional information was received stating the implanted xtw clip deployed on the anterior leaflet completely detached and embolized, causing a tear to the anterior leaflet.It is unknown where the clip embolized within the anatomy.Mr returned to a grade of 4, causing the patient to become symptomatic.It is unknown what symptoms the patient presented.

• 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: 18622734
• MDR Text Key: 334322992
• Report Number: 2135147-2024-00445
• Device Sequence Number: 1
• Product Code: NKM
• 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: 02/23/2024

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: CDS0702-XTW
• Device Lot Number: 30807R1088
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/10/2024
• Initial Date FDA Received: 02/01/2024
• Supplement Dates Manufacturer Received: 02/01/2024
• Supplement Dates FDA Received: 02/23/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/07/2023
• 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