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

Catalog Number CDS0702-NT

Device Problems Unstable (1667); Material Protrusion/Extrusion (2979)

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

Event Date 09/01/2023

Event Type  malfunction  

Event Description

This is filed to report material protrusion it was reported that a mitraclip procedure was performed to treat functional mitral regurgitation (mr) with grade 3+.A mitraclip xtw was implanted without issues.A mitraclip nt was then used, but difficulties deploying the clip occurred.After the actuator knob was turned eight times and retracted 0.5 cm, it came out significantly further than usual 0.5cm (approximately 10-15cm).Extreme force was not applied.There was less resistance than usual.There was almost no resistance noted when the actuator knob was retracted.Further deployment was not a problem.The procedure was completed with two clips implanted.The mr was reduced to grade 1.There was no clinically significant delay in the procedure and no adverse patient effects.No additional information was provided.

Manufacturer Narrative

All available information was investigated, and the reported material protrusion / extrusion (actuator mandrel (proximal)) and unstable (knob - loose) were not confirmed via device analysis.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 complaints 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 (technique in retracting actuator knob).The cause of the reported unstable (knob - loose) associated with the less resistance when rotating the actuator knob could not be determined.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 (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: 17809893
• MDR Text Key: 324236183
• Report Number: 2135147-2023-04162
• 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
• Report Date: 09/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/19/2024
• Device Catalogue Number: CDS0702-NT
• Device Lot Number: 30321R1065
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/01/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/21/2023
• 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: MITRACLIP; STEERABLE GUIDE CATHETER