MAUDE Adverse Event Report: ABBOTT VASCULAR MITRACLIP NTR CLIP DELIVERY SYSTEM; VALVE REPAIR

Model Number CDS0601-NTR

Device Problems Improper or Incorrect Procedure or Method (2017); Material Protrusion/Extrusion (2979); Activation Failure (3270)

Patient Problems Cardiac Arrest (1762); Hemorrhage/Bleeding (1888)

Event Date 02/03/2021

Event Type  Death  

Manufacturer Narrative

(b)(4).The device has been retained by the hospital.A follow-up report will be submitted with all additional relevant information.The steerable guide catheter referenced is filed under a separate medwatch report number.

Event Description

This is filed to report death.It was reported that this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 4+.It was noted that the patient had a severely rotated heart causing imaging to be very challenging.An ntr clip was inserted and the leaflets were successfully grasped.The clip passed the final arm angle test and both the gripper line and lock line were flossed without issues.The lock line was successfully removed, but the physician removed the gripper line prior to removing the release pin.After the release pin was removed, the actuator knob was turned eight times without issues.However, the actuator knob was unable to retract.The actuator knob was then rotated a few more times in the counterclockwise direction and was able to be retracted.However, while pulling on the actuator knob, the physician removed the actuator assembly from the device.The clip was still not deployed and troubleshooting was attempted, but ultimately unsuccessful.Therefore, the patient was transferred to surgery.While in surgery, the clip delivery system (cds) had to be cut down in order to detach the clip.After the clip was cut down, mitral valve replacement was performed.A few hours after mitral valve replacement, the patient was brought back to surgery due to bleeding.It was then observed that a shunt had occurred in the atrial septum.It was noted that no treatment was performed to treat the shunt.The following day, the patient coded; therefore, the chest was opened, and the heart was massaged.Unfortunately, the patient was unable to recover and passed away.The physician stated the patient passed away due to an aortic bleed at the sight of cannulation (ascending aorta).No additional information was provided.

Manufacturer Narrative

The device was not returned.A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot that would have contributed to the reported event.Additionally, a review of the complaint history did not identify any similar complaints.All available information was investigated, but without the device to analyze, a cause for the reported activation failure including failure to deploy the clip and material protrusion could not be determined.The poor image resolution is associated with the procedural circumstances and patient anatomy as imaging was reported to be suboptimal due to a severely rotated heart.It should be noted that the mitraclip system instructions for use (ifu) provides the instructions to deploy the clip and after the delivery catheter (dc) shaft detachment (clip deployment) step, then instructs the user to remove the gripper line.The user error was associated with the removal of the gripper line prior to removing the release pin.However, in this case removal of the gripper line prior to the release pin would not have contributed to the reported issue.The reported hemorrhage resulting in cardiac arrest and death appear to be a result of procedural circumstances.Cardiac arrest, hemorrhage and death are listed in the ifu as known possible complications associated with mitraclip procedures.The unexpected medical intervention, surgical interventions and hospitalization were a result of case-specific circumstances.There is no indication of a product issue with respect to manufacture, design or labeling.

• Brand Name: MITRACLIP NTR CLIP DELIVERY SYSTEM
• Type of Device: VALVE REPAIR
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 11372681
• MDR Text Key: 233286723
• Report Number: 2024168-2021-01419
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 08717648226342
• UDI-Public: 08717648226342
• Combination Product (y/n): N
• PMA/PMN Number: P100009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 07/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/05/2021
• Device Model Number: CDS0601-NTR
• Device Catalogue Number: CDS0601-NTR
• Device Lot Number: 00305U118
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/03/2021
• Initial Date FDA Received: 02/24/2021
• Supplement Dates Manufacturer Received: 06/11/2021
• Supplement Dates FDA Received: 07/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: STEERABLE GUIDE CATHETER; STEERABLE GUIDE CATHETER
• Patient Outcome(s): Death
• Patient Age: 81 YR