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

Catalog Number CDS0705-XTW

Device Problems Difficult or Delayed Activation (2577); Expulsion (2933); Migration (4003)

Patient Problems Foreign Body In Patient (2687); Embolism/Embolus (4438)

Event Date 04/03/2024

Event Type  Injury  

Manufacturer Narrative

Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that a patient presented with grade 4 degenerative mitral regurgitation (mr), posterior leaflet segment 2 (p2) flail, and p2 prolapse (center-lateral) for a mitraclip procedure.The target was the anterior and posterior leaflet segment 2 (a2/p2).One xtw clip was implanted lateral to the prolapse.A second xtw was implanted medial to the first clip, and the third xtw (31031r1011) medial to this second clip.During deployment of the third xtw clip, there was resistance while retracting the delivery catheter (dc) handle to separate the clip from the dc tip.The implanter retracted it with great force, without making slight alignment adjustments to the steerable guide catheter (sgc).This resulted in impact on the leaflets and complete clip detachment.The clip went to the left atrium, and embolized in the ostium of the left pulmonary vein.A fourth xt clip was implanted in place of the third clip.The mr was reduced from grade 4+ to 1+, with a gradient of 3.8mmhg.An attempt was made to capture the embolized clip with a snare (loop) for 1 hour, but without success.The implanter decided to leave the clip in the left pulmonary ostium, monitor the patient over a period of days, and intervene again to remove the clip.The patient remained stable.There was no clinically significant delay.

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 the reported event.Additionally, a review of the complaint history did not indicate a lot-specific product issue.All available information was investigated and based on the information provided and without the device to analyze, a cause for the reported difficult or delayed activation (difficult to deploy the clip) cannot be determined.The reported migration and expulsion appear to be related to procedural conditions and due to the user technique of troubleshooting for the difficult clip deployment.Embolism/embolus and foreign body in patient were related to the procedural conditions associated with the clip completely detaching from both the leaflets (explusion).Embolism is a known possible complication associated with mitraclip procedures.Unexpected medical intervention and hospitalization were a result of case-specific circumstances.There is no indication of a product issue with respect to manufacture, design or labeling.

• 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: 19191881
• MDR Text Key: 341148363
• Report Number: 2135147-2024-01855
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 08717648288647
• UDI-Public: (01)08717648288647(17)241030(10)31031R1011
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/23/2024

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 Catalogue Number: CDS0705-XTW
• Device Lot Number: 31031R1011
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/03/2024
• Initial Date FDA Received: 04/26/2024
• Supplement Dates Manufacturer Received: 05/09/2024
• Supplement Dates FDA Received: 05/23/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/01/2023
• 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: 2 IMPLANTED MITRACLIPS.; STEERABLE GUIDE CATHETER.
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 87 YR
• Patient Sex: Male
• Patient Weight: 80 KG