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

Catalog Number CDS0702-XT

Device Problems Break (1069); Difficult or Delayed Positioning (1157); Difficult or Delayed Activation (2577); Mechanical Jam (2983)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/25/2023

Event Type  Injury  

Manufacturer Narrative

The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.The first mitraclip referenced is filed under a separate medwatch report.

Event Description

This is being filed to report a mitraclip that experienced difficulty during deployment.It was reported that a patient presented with grade 3-4 mixed mitral regurgitation (mr) and calcification at the tip of the anterior leaflet.During a mitraclip procedure, an xtw was the first implanted clip.A second clip was implanted medial to the xtw, to further reduce the mr.During second clip implantation, a single leaflet device attachment (slda) occurred with the xtw (first clip).The anterior mitral leaflet (aml) was detached.The second clip was then placed medial to stabilize the slda.A third clip, an xt, was implanted medial to the second clip to further stabilize the first clip.During deployment of the xt, there was resistance as the clip delivery system (cds) was attempted to be detached.Both of the gripper lines were not detaching from the clip.After troubleshooting, the gripper lines were exposed, and one was stuck to the xt.As a fourth clip was being prepared, the xt was stabilized with an introducer and the gripper line was pulled.The free end of the torn gripper line was found in the left atrium.A fourth clip was placed medial to the three implanted clips for further stabilization.The mr was reduced to grade 1.There was no clinically significant delay or adverse patient sequelae.

Event Description

Subsequent to the previously filed report, additional information was received: while the introducer was stabilizing the third clip as the gripper line was being pulled, a loss of leaflet capture with the anterior mitral leaflet (aml) occurred.The clip was deployed on one leaflet.The third clip was stabilized by the fourth clip.No additional information was provided.

Manufacturer Narrative

All available information was investigated, and the reported difficult or delayed activation (clip deployment), mechanical jam (cga gripper line), break (cga gripper line) and difficult or delayed positioning (leaflet capture) could not be replicated in a testing environment.Additionally, the actuator coupler and actuator mandrel separated at the welded area, and both were corroded.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 difficult or delayed activation (clip deployment) was due to the mechanical jam (cga gripper line) as the gripper line could not be retracted from the clip.A cause of the mechanical jam (cga gripper line) could not be determined.The reported difficult or delayed positioning (leaflet capture) associated with the loss of anterior leaflet capture was due to troubleshooting maneuvers to retract the gripper lines.The reported break (cga gripper line) also appears to be related to the mechanical jam and repeated attempts to retract the jammed gripper line.The observed corroded actuator coupler and actuator mandrel appear to be due to environmental conditions (i.E., moisture, salinity) post procedure.The broken welded actuator assembly appears to be related to the corrosion.The reported foreign body in patient was a result of the gripper line break while in the patient anatomy.The reported unexpected medical intervention was a result of case specific circumstances.There is no indication of a product quality issue with respect to manufacture, design or labeling.H6: clinical code 4614 (serious injury /illness /impairment) was removed.

• 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: 16395932
• MDR Text Key: 309780236
• Report Number: 2135147-2023-00568
• 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: 04/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2023
• Device Catalogue Number: CDS0702-XT
• Device Lot Number: 21130R1065
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/30/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2022
• 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: MITRACLIP (X2).; STEERABLE GUIDE CATHETER.
• Patient Outcome(s): Required Intervention; Other