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

Model Number CDS0706-XT

Device Problems Improper or Incorrect Procedure or Method (2017); Unintended Movement (3026)

Patient Problems Intracranial Hemorrhage (1891); Cardiogenic Shock (2262); Coma (2417); Respiratory Failure (2484); Mitral Valve Insufficiency/ Regurgitation (4451); Unspecified Tissue Injury (4559)

Event Date 01/10/2023

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.2017 improper or incorrect procedure or method was added for not performing second establishing final arm angle (efaa) of the procedure.

Event Description

This is being filed to report a mitraclip xt that opened while locked and perforated a leaflet that led to a cascade of effects.A patient presented with grade 3+ functional mitral regurgitation (mr), small valve area, a dilated left atrium, severe tricuspid regurgitation (tr), severe heart failure, non-ischemic cardiomyopathy, and obstructed sleep apnea.It was noted that the patient was waitlisted for a heart transplant.During a mitraclip procedure, an xtw clip was implanted in the center of a2/p2.It took approximately 34 minutes from steerable guide catheter (sgc) insertion to xtw deployment.While awake, the patient's systolic blood pressure was 90 mmhg and the heart rate was 100 bpm.Under anesthesia the blood pressure dropped a little, and epinephrine was administered.To lessen the effect on the heart rate, the physician requested a transition from epinephrine to levophed (epinephrine can increase heart rate).Oxygen was low 90s and 100 percent on the ventilator, and heart rate was 90-100 bpm.There was increased mobility of the heart cavity/ pericardium.The tidal volume was lowered on the ventilator to decrease mobility and facilitate precision with clip placement.The patient did not respond well to this approach.The solution was to give the patient breaks to recover.Once the xtw clip was implanted, the mr was reduced to grade 2-3, and the blood pressure increased to 130 mmhg as the clip was closed.The increase in blood pressure did not surprise the team, as this is common for functional mr.There was a possibility that blood pressure medication was not adjusted, but this cannot be confirmed.The second clip was an xt, which was placed lateral to the xtw.A grasp was confirmed, first establishing final arm angle (efaa) was successful, and the xt device was ready to deploy.When the lock line was about to be pulled, it was noted that the blood pressure increased to 190 mmhg and the heart rate increased from 110 to 135 bpm.The mr came back, and the deployment sequence was paused to assess the situation and stabilize the vitals.A perforation in the belly of the anterior leaflet was found where the xt was placed.There were issues oxygenating the patient at this point.Per the physician, the issues with oxygenation, increase in blood pressure/hypertension and tachycardia were unrelated to the mitraclip devices.Reportedly, the events were related to the mismanagement of the blood pressure medications and anesthesia provided for the procedure.Additionally, per the physician, the tachycardia, and hypertension contributed to the anterior leaflet perforation, noted where the xt was placed.Once the blood pressure and heart rate were under control, the xt clip was grasped on the other side of the perforation.Only first efaa was performed.After efaa, the clip opened while locked.The xt was closed again, re-opened, and remained stable.The final state of the arm positioner was loose neutral.Second efaa was not performed, due to the urgency of the case and to avoid disrupting the clip.The xt was implanted, with no impact on mr and treated the leaflet perforation with minimal success.To further reduce the mr and stabilize the xt, a third clip (an nt), was implanted.The nt was successfully implanted lateral to the xt clip.The mr was not improved and remained at baseline (grade 3+).After the last mitraclip was implanted, a balloon pump was placed to rest the heart and help oxygenate the patient.This was a continuing effect of the initial mismanagement of blood pressure medication and anesthesia that led to the leaflet perforation.The patient's condition did not improve and continued to struggle with oxygenation.The balloon pump was then removed, and the patient was placed on extracorporeal membrane oxygenation (ecmo) with impella to rest the left ventricle.The patient was stabilized.On thursday, (b)(6) 2023, the patient had an abbott heartmate 3 left ventricular assist device (lvad) implanted and ecmo/impella was removed.The perforation grew into a tear that essentially covered the entire anterior leaflet.The clips were explanted, and mitral valve replacement was performed.The case was successful.Overnight from thursday, (b)(6) 2023, to friday, (b)(6) 2023, the patient developed a cerebral hemorrhage, currently has no brain activity, and was placed on life support.As of (b)(6) 2023, the patient is still on life support.In the physician's opinion the cerebral hemorrhage was caused by the extensive blood thinners from the lvad procedure.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 and without the device to analyze, a cause for the reported clip opening while locked could not be determined.The reported improper or incorrect procedure or method is due to the user deploying the clip without conducting the second efaa check.The reported mr appears to be a cascading event of the clip opening while locked.The reported tissue injury, cardiogenic shock, and respiratory failure appear to be due to procedural conditions.The reported unrelated death is due to complications with the subsequent lvad procedure.Additionally, mr, tissue injury, cardiogenic shock, respiratory failure, and death are listed in the ifu as known possible complications associated with mitraclip procedures.The reported unexpected medical interventions (additional mitraclip, balloon pump, and lvad), surgery, and hospitalization are the results of case-specific circumstances.There is no indication of product issue with respect to manufacture, design or labeling.The provided image was reviewed by an abbott clinical research and development staff engineer.The reviewer stated ¿one powerpoint file was provided containing three (3) fluoroscopic still images.The first image was taken during active use of the second cds (xt clip, reported for cowl) which has the delivery catheter (dc) extended and the clip is grasped onto the leaflets; the clip is attached to the dc shaft indicating the image was taken prior to deployment.However, it is unclear at which step during deployment (e.G.First efaa, lock line removal, second efaa) the image was taken.The first implanted clip (xtw clip, bottom clip in the image) can be seen medial to the second clip.Both clips appear to have a similar arm angle of ~30°.The second fluoro image was taken post deployment of the second clip (top clip in the image) after the cds was removed.The second clip arm angle appears to be ~70° while the first clip arm angle remains unchanged at ~30°.While the angles stated in this evaluation are estimations based on visual assessment with naked eye and are not confirmed, it is apparent that the arm angle of the second clip (reported device) has increased post deployment, as compared to the first image taken pre-deployment.This aligns with the reported incident details that the second clip (reported device) experienced a cowl event.Reportedly, a second efaa check was not performed and the clip was deployed "due to the urgency of the case and to avoid disrupting the clip".It should be noted that deploying a clip without conducting the second efaa check is against the ifu.The third image was taken post deployment of the third clip (nt clip, no reported issue).The clip arm angle of the second clip (middle clip in the image, reported device) remains stable and does not appear to have changed, as compared to the second image.There are no additional observations based on the videos.¿ b5: the abbott heartmate 3 left ventricular assist device (lvad) is filed under a separate medwatch report.H6 health effect - clinical codes 2417 and 1891 were removed h6 health effect - impact code 1802 was removed.

Event Description

Subsequent to the initial report.Overnight, from thursday, (b)(6) 2023, it was reported that the patient was noted to have non-reactive pupils post-procedure with an abbott heartmate 3 left ventricular assist device (lvad) and post-mitraclip resection / mitral valve repair.A computed tomography (ct) scan of their head revealed a left frontal intracerebral hemorrhage (ich) with midline shift and uncal herniation.The patient was brought back to the operating room (or) for a left frontal craniotomy and ich evacuation.Per the physician, the cerebral hemorrhage was caused by the extensive blood thinners from the lvad procedure.On (b)(6) 2023 the patient was still on life support due to the cerebral hemorrhage.The patient passed away on (b)(6) 2023.No additional information was provided.

• 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: 16299118
• MDR Text Key: 308823744
• Report Number: 2135147-2023-00391
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 05415067037404
• UDI-Public: 05415067037404
• 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: 05/16/2023

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: 11/10/2023
• Device Model Number: CDS0706-XT
• Device Catalogue Number: CDS0706-XT
• Device Lot Number: 21111R1072
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/10/2023
• Initial Date FDA Received: 02/03/2023
• Supplement Dates Manufacturer Received: 05/01/2023
• Supplement Dates FDA Received: 05/16/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/11/2022
• 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): Hospitalization; Disability; Required Intervention; Life Threatening
• Patient Age: 19 YR
• Patient Sex: Female
• Patient Weight: 82 KG