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

Model Number N/A

Device Problems Break (1069); Difficult or Delayed Positioning (1157); Expulsion (2933)

Patient Problems Foreign Body In Patient (2687); Embolism/Embolus (4438); Unspecified Tissue Injury (4559)

Event Date 10/11/2022

Event Type  Death  

Manufacturer Narrative

Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.The additional mitraclip device referenced in b5 is filed under separate medwatch report number.Na.

Event Description

This is filed to report clip embolization requiring intervention and death.It was reported that on (b)(6) 2022, a mitraclip procedure was performed to treat degenerative mitral regurgitation (mr) grade of 4+ with an anterior (a2) leaflet flail and enlarged atrium.An ntw clip (20520r126) was advanced to the mitral valve; however, it was not possible to grasp the leaflets.The ntw clip was removed with no reported issue and replaced.An xtw clip (20308r128) was advanced to the mitral valve and after several attempts to grasp the leaflets, the gripper stopped working properly.The xtw clip was removed with no reported issue and replaced.Another xtw clip (20614r175) was advanced to the mitral valve and after several grasping attempts tissue damage was noticed.The procedure continued, the leaflets were grasped and the clip was deployed.However, during deployment, when pulling the actuator knob, the clip rose into the left atrium and detached from both leaflets.It was noted that there was no immediate disconnection between the clip and the delivery system.Therefore, an attempt was made to retract the embolized clip into the steerable guide catheter (sgc).While the cds was pulled into the sgc, the clip detached from the cds and embolized.The patient was converted to surgery.The clip was removed from the heart, however it was noted that a piece of the gripper line was still attached to the clip.The patient then had their mitral valve replaced.The patient did not leave cpb (extracorporeal circulation) and died on (b)(6) 2022.No additional information was provided.

Manufacturer Narrative

All available information was investigated, and the reported expulsion, difficult leaflet grasping, and poor image resolution could not be replicated in a testing environment.The reported broken gripper line was confirmed via returned 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 incidents reported from this lot.Based on available information and the returned device analysis, the cause of the reported expulsion (ccd), broken gripper line, poor image resolution, and death were unable to be determined.The reported difficult leaflet grasping was due to procedural circumstances.The reported tissue injury was likely related to the reported difficult leaflet grasping.The reported embolism and foreign body in patient were cascading events of the reported expulsion (ccd).The reported patient effect of death, tissue injury, and embolism as listed in the mitraclip system instructions for use are known possible complications associated with mitraclip procedures.The reported surgical intervention, delay of treatment, and removal of foreign body were results of case-specific circumstances.There is no indication of a product quality issue with respect to manufacture, design or labeling.Product performance engineering reviewed the incident information provided to abbott, manufacturing records, complaint history for the reported lot and performed analysis of the returned device.Reportedly, it was a mitraclip procedure performed to treat mitral regurgitation (mr) grade 4+.The patient presented with an anterior leaflet flail, large atrium, bileaflet prolapse, long anterior leaflet, short posterior leaflet, and dilated mitral annulus.Two clips were attempted to be implanted.Both clips had difficulty grasping the leaflets with ~15 combined attempts.The third clip (xtw) was advanced to the mitral valve and after several grasping attempts (~15 attempts) tissue damage was noticed.The procedure continued, the leaflets were grasped and the clip was deployed.However, during deployment, when pulling the actuator knob, the clip rose into the left atrium and detached from both leaflets.It was noted that there was no immediate disconnection between the clip and the delivery system.Therefore, an attempt was made to retract the embolized clip into the steerable guide catheter (sgc).While the cds was pulled into the sgc, the clip detached from the cds and embolized.The patient was converted to surgery.The clip was removed from the heart, however it was noted that a piece of the gripper line was still attached to the clip.The patient then had their mitral valve replaced.The patient did not leave cpb (extracorporeal circulation) and died.In this case, the returned device analysis confirmed the broken gripper line.The reported expulsion (ccd) could not be replicated in a testing environment due to the condition of the returned device (clip was deployed).The reported difficult leaflet grasping and poor image resolution could not be replicated in a testing environment as it was related to patient anatomy or procedural operational circumstances.Additionally, the gripper arm was observed to be sticking out of the clip and the gripper line stuck in the clip was observed to be kinked.Based on available information and the returned device analysis, the cause of the reported expulsion was unable to be determined.It is possible that user technique (positioning too high above valve, pulling the actuator knob and retracting the dc handle to deploy clip) contributed to the reported event; however, this could not be confirmed.The cause of the reported broken gripper line was unable to be determined.It is possible that technique of retraction of the clip into the sgc contributed to the reported event; however, this could not be confirmed.The reported difficult leaflet grasping was due to procedural circumstances (user technique, challenging patient anatomy).The cause of the reported poor image resolution was unable to be determined.It is possible that equipment limitations or patient anatomy contributed to the user experience; however, this could not be confirmed.The observed deformed gripper arm and gripper line are unrelated and won¿t contribute to the reported issue as they are likely due to post procedural handling (removal of clip during surgery).The cause of the reported death was undetermined.It is possible that patient condition contributed to the patient death; however, this could not be confirmed.The reported tissue injury was likely related to the reported difficult leaflet grasping as ~15 grasping attempts were made with this clip.The reported embolism and foreign body in patient were cascading events of the reported expulsion (ccd).Additionally, the reported patient effect of death, tissue injury, and embolism, are listed in the mitraclip system instructions for use (ppl2128518, revision a, potential complications and adverse events section), and are known possible complications associated with mitraclip procedures.The reported surgical intervention, delay of treatment, and removal of foreign body were results of case-specific circumstances as the patient was converted to mitral valve replacement surgery and the embolized clip was removed.The broken gripper line was submitted to the materials characterization lab (mcl) for scanning electron microscopy (sem) and failure analysis.The analysis concluded that the broken gripper line (gl) exhibited severe ¿necking¿ (elongation) at the fracture.The fracture morphology exhibited ductile dimples characteristic of a tensile fracture.No evidence of inclusions was found during the analysis.(refer to pit-002395 within this complaint record for additional details) the trumpet end of the gripper line was submitted to the materials characterization lab (mcl) for scanning electron microscopy (sem).The analysis concluded that on two of the four sides of the gripper line trumpet, burnishing and cracks were found.(refer to pit-002463 within this complaint record for additional details) the clip connector was submitted to the materials characterization lab (mcl) for scanning electron microscopy (sem).The analysis concluded that the proximal id of the clip connector appeared to have some metal smearing.The od of the clip connector did not exhibit any evidence of mechanical damage (scratches).(refer to pit-002534 within this complaint record for additional details) additionally, this event and the imaging provided by the account were further reviewed by the clinical r&d (research and development) staff engineer, and the reviewer stated that ¿this confirms that the clip was not mechanically separated from the dc shaft during this maneuver, and aligns with the reported incident details that 'it was noted that there was no immediate disconnection between the clip and the delivery system'.The dc handle was incorrectly retracted into the la during the deployment attempt, prior to mechanical separation of the clip and is indicative of use error.¿ (refer to pit-002589 within the complaint record for additional details) the event was further reviewed by an abbott medical affairs team.The reviewer stated that ¿the failure of the clip to release from the cds and eventual embolization of the clip necessitated an urgent surgery to remove the clip.The patient could not be weaned from cpb and died.The failure of the clip to release from the cds and eventual embolization was the major contributor to the patient¿s death as it necessitated the urgent open-heart surgery and cpb.After reviewing echo images and reviewing engineering evaluation, one possible explanation is that the cds handle was not sufficiently locked in place when the clip was being released.While this seems like a reasonable explanation, at this time we do not have sufficient information to make a define a definitive etiology.However, there is no clear evidence to suggest device failure.¿ (refer to pit-002205 and pit-002621 within this complaint record for additional details).

• 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: 15729960
• MDR Text Key: 303034006
• Report Number: 2135147-2022-01926
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: P100009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/14/2023
• Device Model Number: N/A
• Device Catalogue Number: CDS0705-XTW
• Device Lot Number: 20614R175
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/15/2022
• 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
• Patient Outcome(s): Death; Required Intervention
• Patient Age: 87 YR
• Patient Sex: Male