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

Catalog Number CDS0702-XTW

Device Problem Material Protrusion/Extrusion (2979)

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

Event Date 02/10/2023

Event Type  malfunction  

Event Description

This is filed to report material protrusion.It was reported that a mitraclip procedure was performed to treat degenerative mitral regurgitation (mr) with grade 3.An xtw clip was inserted and placed on the mitral valve.While deploying the clip, the actuator knob was pulled back but the proximal end of the mandrel pulled out completely.The clip was successfully deployed and was stable on the leaflets.Mr was reduced to a grade of 1.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

The device is expected to be returned for evaluation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.

Event Description

N/a.

Manufacturer Narrative

All available information was investigated, and the device analysis confirmed that the actuator assembly was retracted.Additionally, the actuator mandrel was observed to be bent at the proximal end.A review of the lot history record revealed no manufacturing nonconformities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 incidents reported from this lot.Based on available information, the reported material protrusion / extrusion (actuator mandrel (proximal)) associated with the actuator assembly being retracted to where the actuator mandrel is visible appears to be due to procedural circumstances (user technique in retracting actuator knob).The observed deformation due to compressive stress associated with the proximal bend on the actuator mandrel appears to be due to post-procedural/ shipping conditions, as the actuator mandrel was bent where it connects to the rest of the actuator assembly, and the device was returned with the actuator mandrel exposed.There is no indication of a product quality issue with respect to manufacture, design, or labeling.

• Brand Name: MITRACLIP G4 CLIP DELIVERY SYSTEM
• 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: 16496460
• MDR Text Key: 310859954
• Report Number: 2135147-2023-01042
• 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: 03/28/2023

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: 10/16/2023
• Device Catalogue Number: CDS0702-XTW
• Device Lot Number: 21017R1018
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/10/2023
• Initial Date FDA Received: 03/07/2023
• Supplement Dates Manufacturer Received: 03/23/2023
• Supplement Dates FDA Received: 03/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/17/2022
• 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.