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

Catalog Number CDS0706-XTW

Device Problems Break (1069); Positioning Failure (1158); Difficult to Remove (1528); Retraction Problem (1536); Improper or Incorrect Procedure or Method (2017); Deformation Due to Compressive Stress (2889); Difficult to Open or Close (2921); Expulsion (2933)

Patient Problems Cardiac Arrest (1762); Hemorrhage/Bleeding (1888); Low Blood Pressure/ Hypotension (1914); Foreign Body In Patient (2687); Pericardial Effusion (3271); Embolism/Embolus (4438)

Event Date 07/26/2023

Event Type  Death  

Manufacturer Narrative

The device will not be returned for evaluation as the device was reportedly discarded.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 being filed under a separate medwatch report number.H6: device code 2017 - failure to follow steps / instructions.

Event Description

This will be filed to report patient death, a single gripper actuation issue, and a clip that was unable to be closed.It was reported that a mitraclip procedure was performed to treat functional mitral regurgitation (mr) grade 4+ with an anterior leaflet flail.The physician advanced the clip into the ventricle (lv), but grasping was noted to be difficult.The clip was repositioned, but it was observed the posterior gripper would not lower.Troubleshooting was performed, but the issue was unable to be resolved.The physician then attempted to retract the clip back into the left atrium (la).However, resistance was felt while retracting the delivery catheter (dc) handle.The clip was able to be pulled back into the la, but at this time, a pericardial effusion was observed and the patient's blood pressure decreased, resulting in a clinically significant delay in the procedure.Pericardiocentesis was performed, but the effusion and blood pressure did not change.The clip was then attempted to be closed in an attempt to retract, but the clip was unable to close.The physician decided to retract the clip into the steerable guide catheter (sgc).However, the clip became caught on the soft tip of the sgc, causing damage to the soft tip and a bend in one of the clip arms.Both the sgc and clip delivery system (cds) were attempted to be removed together, but became stuck in the vein.At this point, the patient went into cardiac arrest and compressions were administered.The mitraclip devices were then forcefully removed from the patient in order to perform open heart surgery.It was noted the forceful removal of the device caused the clip to detach from the mandrel.Open heart surgery was attempted, but was unsuccessful as the patient bleed out and died.No additional information was provided.

Manufacturer Narrative

The device was not returned for 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 did not indicate a lot-specific quality issue.Based on available information, a cause of the reported positioning failure (leaflet grasping - clip not implanted), associated with the grasping difficulty, could not be determined.The reported difficult to open or close (gripper actuation - single), associated with the posterior gripper not lowering, was due to tissue interactions.Without the device to analyze, a cause of the reported retraction problem (dc handle - retraction), associated with the resistance felt during dc (delivery catheter) handle retraction, could not be determined.A cause of the reported difficult to open or close (clip close - inability), associated with the clip not closing, could not be determined.The reported deformation due to compressive stress, associated with the sgc soft tip damage and bent clip arm, was due to retraction of opened clip into the sgc (steerable guide catheter).The reported difficult to remove (cds/sgc), associated with the clip getting stuck in vein during system removal, was due to the attempt to remove the entire system (sgc and cds) with the clip opened.The reported improper or incorrect procedure or method was associated with the user retracting the clip into sgc while the clip remained open and pulling the opened clip into the vein.The reported expulsion (clip remains on gripper line and lock line), and the reported break, associated with the missing clip components observed outside of patient, was related to the system removal attempt with the clip opened, as this could impose excessive stress onto clip structure.The reported hypotension was secondary to the pericardial effusion.A cause of the reported pericardial effusion could not be determined.The reported foreign body in patient and embolism were associated with the missing clip components observed.A cause of the reported cardiac arrest requiring compression could not be determined.The reported bleeding appears to be related to the pericardial effusion and/or the open-heart surgery.The reported death of patient was due to av disruption.The reported patient effects of death, hypotension, cardiac arrest, pericardial effusion, hemorrhage, and embolism, as listed in the mitraclip system instructions for use, are known possible complications associated with mitraclip procedures.The reported unexpected medical interventions, surgical intervention, and delay to treatment/ therapy were results of case-specific circumstances.There is no indication of a product quality issue with respect to manufacture, design, or labeling.The event was further reviewed by an abbott medical affairs team.The reviewer stated the following: the cause of death was trauma from the device and/or cds to the lateral wall of the left atrium with a laceration noted in this location at the time of urgent surgery.Please note that during the procedure there was multiple attempts to grasp the leaflets which were not successful and, eventually, a gripper would not lower or raise adequately; this was likely due to tissue entrapment, however, device malfunction cannot be excluded.Additionally, when the physician attempted to close the clip to remove it through the sgc, it would not close.Again, this could be due to tissue entrapment, however, device malfunction cannot be excluded.The trauma to the atrial wall which caused the hemopericardium and hemodynamic decompensation occurred during attempts to free the clip after it became entangled; this included pronounced movements of the m knob and retraction of the cds back into the left atrium to dislodge the clip.The clip did pull free and likely injured the atrial wall.Additionally, the physician attempted to pull clip with the open arms in to the sgc.As it could not be pulled in with open arms, the entire system was withdrawn and it then become "stuck in the vein".The specific vein was not noted in the narrative.In summary, the death was likely due to physician technique and measured used by the physician to free the entangled clip likely contributed to the atrial injury and eventual death of the patient.Since the description of the procedure included reference to grippers and clip arms not functioning as intended during the procedure, i cannot exclude the possibility the device malfunction contributed to the atrial injury and death or to what degree this may have contributed.If the device/cds/sgc are returned and evaluated and found to be defective or not found to be functioning as intended, the medical review may be updated.Addendum medical review: given the additional information provided, it is much more likely that manipulations of the device caused injury to the atrial wall and hemodynamic compromise; thus, the complication is most likely procedure related rather than a device malfunction.Na.

• Brand Name: MITRACLIP G4 CLIP DELIVERY SYSTEM (MDR)
• 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: 17574944
• MDR Text Key: 321455797
• Report Number: 2135147-2023-03606
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 05415067037381
• UDI-Public: 05415067037381
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/28/2023

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: 03/19/2024
• Device Catalogue Number: CDS0706-XTW
• Device Lot Number: 30320R1033
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: STEERABLE GUIDE CATHETER
• Patient Outcome(s): Death
• Patient Age: 85 YR
• Patient Sex: Female
• Patient Weight: 59 KG