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

Model Number CDS0706-XTW

Device Problems Break (1069); Entrapment of Device (1212); Difficult to Open or Close (2921)

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

Event Date 06/07/2023

Event Type  Injury  

Manufacturer Narrative

Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

This filed to report clip caught in chordae, gripper actuation issue, gripper line break, and intervention.It was reported that a mitraclip procedure was performed to treat functional mitral regurgitation (mr) with a grade of 4+.The patient presented with a thick chordal network and a rotated heart.It was noted that imaging was challenging due to patient¿s anatomy.During positioning, the gripper line got entangled with the anterior leaflet.During attempts to free the clip, the gripper stopped working.The assumption was that the gripper line broke.It was not possible to free the clip.The clip was able to be deployed on both leaflets and chordae.The clip is stable on the leaflets.Another clip was implanted to stabilize the first clip.Mr was reduced to grade 2.There was no clinically significant delay in the procedure and no adverse patient effects.No additional information was provided.

Manufacturer Narrative

The returned device confirmed the broken gripper line.The reported difficult gripper actuation could not be replicated in a testing environment due to the condition of the returned device (clip was deployed).The reported entrapment of device (clip caught on chordae) and poor imaging could not be replicated in a testing environment as these issues were related to patient anatomy, procedural conditions, or operational circumstances.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no similar complaints reported from this lot.Based on the available information, the reported difficult gripper actuation appears to be due to the broken gripper line.The broken gripper line is a cascading event of the troubleshooting performed for the entrapment of device (clip caught on chordae).The reported entrapment of device (clip caught on chordae) is due to challenging patient anatomy.The reported poor imaging is due to challenging patient anatomy.The reported unexpected medical intervention is the result of case-specific circumstances.There is no indication of 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: 17220369
• MDR Text Key: 318076496
• Report Number: 2135147-2023-02836
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 05415067037381
• UDI-Public: 05415067037381
• 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: 09/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/08/2024
• Device Model Number: CDS0706-XTW
• Device Catalogue Number: CDS0706-XTW
• Device Lot Number: 30208R2084
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/09/2023
• 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: 67 YR
• Patient Sex: Male
• Patient Weight: 126 KG