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

Catalog Number CDS0706-XTW

Device Problems Incomplete Coaptation (2507); Device Damaged by Another Device (2915); Expulsion (2933)

Patient Problems Hypoxia (1918); Embolism/Embolus (4438)

Event Date 02/06/2024

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 being filed under a separate medwatch report.

Event Description

It was reported this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 4+.An xtw clip was successfully implanted.To further reduce mr, an xt clip prep per ifu and was inserted.While positioning the clip, "gross movements" were made and undone.After evaluation of the fluoroscopic and echocardiographic imaging, the clip was visualized sub valvular in the lateral commissure.This caused the the first clip to detach from the anterior leaflet and remained attached to the posterior leaflet (single leaflet device attachment/slda).It was noted that oxygen started to desaturate.A balloon pump was inserted to keep vitals stable.Further attempts were made to stabilize the slda but were unsuccessful.It was then observed, the first clip completely detached and embolized in the descending aorta.A snared was inserted and the clip was retracted and secured at the groin.The patient then underwent a surgical operation to replace the mitral valve.However, during the procedure, the patient expired.

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, the reported incomplete coaptation (slda, single leaflet device attachment), associated with clip detachment from the anterior leaflet, was due to interaction with another clip being attempted.The reported device damaged by another device (dislodged), associated with the clip-to-clip interaction, was due to gross movement being made during positioning of another clip.The reported expulsion (ccd, complete clip detachment) appears to be related to the slda as the clip was destabilized.The reported hypoxia (oxygen desaturation after the slda) was related to worsened mr from the slda.The reported device embolism was a result of the clip detachment.The reported death was related to the embolization of the complaint clip.The reported patient effects of embolism and death, as listed in the mitraclip system instructions for use, are known possible complications associated with mitraclip procedures.The reported unexpected medical interventions, removal of foreign body, and surgical intervention 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 patient had initial successful xtw @ a2/p2 for fmr; a second clip (xt) was passed below the valve to treated residual medial mr.Grasp was successful, however, there was mr between clips and the xt was released and passed laterally.From the rfi, it seems that the entire system was advanced laterally, however, the lateral movement was more pronounced than intended and the xtw (first clip) was released from the amvl (slda).The xt was noted to be in the lateral commissure.The patient's mr worsened and an iabp was inserted due to hemodynamic instability.Attempts to stabilize the xtw led to embolization of that clip to the aorta necessitating snaring and retrieval to the femoral vein (not removed entirely).It was decided to proceed to urgent open-heart surgery.The patient died during the procedure.The cause of death was due to the intra-procedural clip embolization which caused a cascade of events requiring urgent open-heart surgery which the patient did not survive.No obvious clip malfunction was noted.No imaging provided.

• 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: 18802438
• MDR Text Key: 336483493
• Report Number: 2135147-2024-00923
• 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: 03/12/2024

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: 02/20/2024
• Device Catalogue Number: CDS0706-XTW
• Device Lot Number: 30220R1090
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/06/2024
• Initial Date FDA Received: 02/28/2024
• Supplement Dates Manufacturer Received: 03/05/2024
• Supplement Dates FDA Received: 03/12/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/21/2023
• 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: IMPLANTED MITRACLIP.; STEERABLE GUIDE CATHETER.
• Patient Outcome(s): Death