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

Model Number CDS0706-XTW

Device Problems Difficult or Delayed Positioning (1157); Product Quality Problem (1506); Difficult to Open or Close (2921)

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

Event Date 05/16/2023

Event Type  malfunction  

Event Description

This will be filed to report a gripper actuation issue.It was reported that a mitraclip procedure was performed to treat degenerative mitral regurgitation (mr) grade 4+ with posterior leaflet flail.It was noted that imaging was challenging throughout the procedure.While advancing the clip, the height was lost due to the septum sagging.Due to this event the clip became entangled in chordae.Troubleshooting was performed and was successful, however, the anterior gripper was no longer functional.Subsequently, the clip was removed and exchanged.Upon inspection of the clip, it was noticed that the gripper line was no longer visible.The procedure was concluded with a resulting mr of grade 3.There was no clinically significant delay in the procedure and no adverse patient sequelae.No additional information was provided.

Manufacturer Narrative

The device has been received.However, investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.Na.

Manufacturer Narrative

In this case, during return device analysis, the reported difficult or delayed positioning (anatomy) and image resolution poor could not be replicated in a testing environment.A visual inspection of the device found that the gripper line was broken and the reported difficult to open or close (gripper actuation - single) was confirmed.Additionally, a visual inspection confirmed the reported product quality problem (irregular appearance - no gripper line visible).A review of the lot history record revealed 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 available information and return device analysis the reported image resolution poor cannot be determined.The cause of the reported delayed positioning (anatomy) associated with the clip getting caught in the chordae appears to be due to a combination of procedural conditions (septum sagging) and patient anatomy (aneurysmal septum).The cause of the observed broken gripper line appears to be due to procedural conditions.The reported product quality problem (irregular appearance - no gripper line visible) appears to be due to a combination of the broken gripper line and troubleshooting steps performed to retract clip from the chordae.The reported difficult to open or close (gripper actuation - single) is a cascading effect of the reported broken gripper line.There is no indication of a product quality issue with respect to manufacture, design, or labeling.

Event Description

N/a.

• 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 MEDICAL NORTHPOINT REG 3020950818; 1820 bastian court; westfield IN 46074
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 17081257
• MDR Text Key: 317133506
• Report Number: 2135147-2023-02491
• 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: 07/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/20/2024
• Device Model Number: CDS0706-XTW
• Device Catalogue Number: CDS0706-XTW
• Device Lot Number: 30221A1062
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/31/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/16/2023
• Initial Date FDA Received: 06/07/2023
• Supplement Dates Manufacturer Received: 06/28/2023
• Supplement Dates FDA Received: 07/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/21/2023
• 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 Age: 85 YR
• Patient Sex: Female
• Patient Weight: 56 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White