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

Catalog Number CDS0702-XT

Device Problems Break (1069); Difficult to Remove (1528); Difficult to Open or Close (2921); Unintended Movement (3026)

Patient Problems Foreign Body In Patient (2687); Embolism/Embolus (4438)

Event Date 07/26/2023

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 is filed to report the clip opening while establishing final arm angle, the clip breaking, detached grippers embolizing, and intervention.It was reported that a mitraclip procedure was performed to treat functional mitral regurgitation (mr) grade 4+.The first used mitraclip was implanted without issues.A second mitraclip xt was then attempted to be implanted.After several grasping attempts with the mitraclip xt, a good position was found.After establishing the final arm angle, the clip failed to close completely, it would reopen approximately 5 to 10 degrees.It was decided to remove the clip from the patient.The physician attempted to pull the clip back into the steerable guide catheter (sgc) from the closed position, but it could not due to the opening.The physician tried to force it into the sgc again, but then the clip broke at the binding plate allowing the clip to fully embolize as the lock line also became detached due to the break.Part of the clip was snared and pulled to the femoral vein where the vascular surgeon then removed the clip.However, the grippers had detached and remained in the atrium.It was decided to leave the grippers in the patient and not attempt removal.No additional information was provided.

Manufacturer Narrative

All available information was investigated, and the reported unintended movement (clip open - efaa), difficult to open or close (clip close - inability), and difficult to remove (cds/sgc) could not be replicated in a testing environment.The reported break was not confirmed via device analysis.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 foreign body in patient (no treatment) and embolism/embolus (therapy/non-surgical treatment, additional) associated with the clip components embolizing into anatomy were due to the clip components (clip arms and grippers) separating from the connecter and delivery catheter.The reported break associated with the perceived component breakage, the observed material separation associated with the clip separation, the observed missing gripper/ leaf spring/ binding plate, the observed hinge pin disengagement, the observed harness deformation, and the observed lock line fray, were due to forces put on the clip during forced withdrawal into the sgc tip.The reported difficult to remove (cds/sgc) associated with the clip catching on the sgc tip was due to the inability to completely close the clip.The cause of the reported difficult to open or close (clip close - inability), and the reported unintended movement (clip open - efaa), could not be determined.The observed corroded associated with the connector and hinge pin corrosion appear to be due to post-procedural shipping/ storage conditions.The reported patient effect of embolism, as listed in the mitraclip system instructions for use, is a known possible complication associated with mitraclip procedures.The reported surgical intervention was a result of case-specific circumstances.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: 17577188
• MDR Text Key: 321516678
• Report Number: 2135147-2023-03620
• 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: 09/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/20/2024
• Device Catalogue Number: CDS0702-XT
• Device Lot Number: 30322R1024
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/22/2023
• 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: 83 YR
• Patient Sex: Male