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

Catalog Number CDS0705-XTW

Device Problems Difficult to Open or Close (2921); Expulsion (2933); Material Deformation (2976); Mechanical Jam (2983); Unintended Movement (3026); Physical Resistance/Sticking (4012)

Patient Problems Cardiac Arrest (1762); Low Blood Pressure/ Hypotension (1914); Multiple Organ Failure (3261); Embolism/Embolus (4438); Heart Failure/Congestive Heart Failure (4446)

Event Date 06/29/2023

Event Type  Death  

Manufacturer Narrative

The device is expected to be returned for evaluation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.

Event Description

This will be filed to report a clip that opened while locked and embolized.It was reported that on (b)(6) 2023 a mitraclip procedure was performed to treat mixed mitral regurgitation (mr) with a grade of 4+, a prolapsed posterior leaflet, and dilated left atrium.The deployment steps were initiated and while removing the lock line resistance was felt in the lock line and arm positioner, and the lock line was unable to be removed.Resistance was also felt while attempting to close the clip.Troubleshooting was performed and was unsuccessful.The physician moved on in the deployment process and after the release pin was removed the clip opened and embolized in the patient, resulting in a clinically significant delay.Attempts to remove the clip percutaneously failed, subsequently, the femoral vein was cut down and the clip was removed.The procedure was concluded with an mr of grade 4 and no clips implanted.The next day the patient expired due to multiorgan failure.No additional information was provided.

Event Description

Subsequent to the previously reported information, it was further reported that the lock line was not visible and difficult to remove.It was noted the lock line had to be retrieved using hemostats to unwind the polyamide tubing.The physician was moving quickly and knots in the lock line could not be checked for.It was also noted resistance was felt while turning the m-knob and when the clip jumped open to the inverted position, it remained attached to the lock line.The clip was pulled into the femoral artery were the snare technique was performed multiple times to retrieve the clip.While performing the technique, the lock line was severed, embolizing the clip.The clip was unable to be removed, subsequently a left arteriotomy was performed.During the arteriotomy the patients blood pressure dropped and cardiopulmonary resuscitation (cpr) was performed.The patient was stabilized with anesthesia, cpr was successful, and the clip was able to be retrieved.The patient was then transferred to the intensive care unit where the patients ejection fraction became progressively worse, leading to the heart and multiorgan failure.No additional information was provided.

Manufacturer Narrative

In this case, the returned device analysis confirmed the reported knot on the lock line and inability to remove the lock line.The reported clip jumps open while locked, and clip expulsion could not be replicated in a testing environment.The reported resistance in the m-knob and arm positioner were unable to be confirmed during the analysis.Additionally, it was observed that the actuator mandrel was deformed, l-lock tabs were scratched, and the lock line was severed.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 and return device analysis, the reported inability to remove the lock line was due to an observed knot in the lock line.A cause of the observed knot in the lock line could not be determined.The cause of the reported clip arms jumping open while locked during the procedure appears to be due to the delivery catheter being separated from the clip while a knot in the lock line still put pressure on the locking mechanism of the clip, allowing the clip to open.Deploying the clip while tension is being applied from the lock line onto the locking mechanism of the clip could allow the clip to open.The severed lock line was due to procedural condition (as the lock line was severed during the snaring process).The reported clip expulsion associated with the clip detaching from the leaflets was due to the clip jumping open after detachment from the dc with a knot applying tension.The reported embolism was due to the lock line being severed while the clip was only attached to the cds via the lock line.The cause of the reported m-knob resistance and arm positioner resistance could not be determined, as they were not replicated during analysis.The observed actuator mandrel deformation appears to be due to post-procedural shipping/ storage of the device, as the device was returned with the m-knob applied, and such a deformation being present prior to deployment would have caused difficulty unthreading the actuator coupler.The reported drop in the blood pressure, cardiac arrest, heart failure, and organ failure could not be determined.The observed scratches on the l-lock tabs appear to be due to post procedural handling of the device.The reported death appears to be a result of the multi organ failure.Additionally, the reported patient effects of embolism, death, hypotension, heart failure and cardiac arrest are listed in the mitraclip system instructions for use, and are known possible complications associated with mitraclip procedures.The reported medical interventions (snaring attempts & cpr - cardiopulmonary resuscitation), surgical intervention, removal of foreign body, medication required, delay to treatment, and prolonged hospitalization and were results of case-specific circumstances.There is no indication of a product quality issue with respect to manufacture, design, or labeling.This event was further reviewed by an abbott vascular senior director of medical affairs, and the reviewer stated that ¿there is not enough details in the narrative to determine how or why the lock like developed resistance and could not be removed or what ultimately caused the embolization of the clip.I noted that the patient had a cardiomemes indicating they had a history of heart failure.I also cannot comment on the cause of death as no details were provided on how the patient died.I cannot determine if the failed mitraclip procedure contributed to the patient's death.Should more details come available, i can provide an addendum to this report.Addendum (8/14/2023): additional information was received from the field team.The clip actually embolized in to the lv then to the aorta and lodged in the femoral artery, not the femoral vein as communicated in the narrative.This was surgically removed.Additionally, the field rep could not confirm if the lock line was "flossed" before attempts to remove it as the physician "went too fast".Thus, it is possible that a knot was present and represented the cause of the resistance encountered in the lock line after 30 cm of the line was removed.An efaa check was performed with the entrapped lock line in place; the physician elected to deploy the clip; upon release of the pin and grippers, the clip inverted and embolized.The lock like was still attached, however, attempt to withdraw the clip in to the sgc were not successful as were attempts to snare the clip.Eventually, surgery was required as above.It is not clear if the lock line remained attached to the clip when it embolized out of the heart.No additional details were provided as to the actual cause of death.Thus, i cannot determine with certainty to what degree the device embolization contributed to the patients death; however, given the need for urgent vascular surgery, it is likely that the chain of cascading events caused by the embolization contributed to the patient's instability and death.I remain suspicious that a knot in the lock line may have been present and contributed to inability to remove the lock line, however, this cannot be definitively stated.Cine: there is no additional information that was able to be obtained from the cine imaging provided.

• 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: 17379557
• MDR Text Key: 319592499
• Report Number: 2135147-2023-03151
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• Reporter Country Code: CS
• 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: 09/05/2023

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: 05/16/2024
• Device Catalogue Number: CDS0705-XTW
• Device Lot Number: 30518R1096
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/29/2023
• Initial Date FDA Received: 07/24/2023
• Supplement Dates Manufacturer Received: 08/30/2023
• Supplement Dates FDA Received: 09/05/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/18/2023
• 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: 74 YR
• Patient Sex: Male
• Patient Weight: 76 KG
• Patient Ethnicity: Hispanic