MAUDE Adverse Event Report: ABBOTT MEDICAL MITRACLIP® SYSTEM CLIP DELIVERY SYSTEM; VALVE REPAIR

Catalog Number UNK CDS

Device Problems Incomplete Coaptation (2507); Expulsion (2933)

Patient Problems Dyspnea (1816); Pain (1994); Embolism/Embolus (4438); Mitral Valve Insufficiency/ Regurgitation (4451); Unspecified Tissue Injury (4559)

Event Date 04/26/2023

Event Type  Injury  

Manufacturer Narrative

B3 - date of event is estimated.D6 - the implant date is estimated.D4 - the udi number is not known as the part and lot numbers were not provided the device was not returned for analysis.The lot history record (lhr) review was not performed because this incident was based on an article review and no lot information was provided.Additionally, the complaint history review was not performed because this incident was based on an article review and no lot information was provided.Based on available information, the reported pain was due to the clip embolizing into the right common iliac artery bifurcation.The reported embolism/embolus (surgical procedure) associated with the clip embolizing into the right common iliac artery bifurcation was due to the clip detaching from the posterior leaflet (after slda).The reported unspecified tissue injury associated with the small chordae rupture appears to be due to the clip detaching from its implanted location.The cause of the reported expulsion associated with the clip detaching and being freed in anatomy, and the cause of the reported incomplete coaptation (intraprocedure) associated with the slda, could not be determined.The reported dyspnea appears to be due to the recurrent severe mr.The cause of the reported mitral valve insufficiency/ regurgitation (recurrent mr) could not be determined.The reported patient effects of mitral regurgitation, tissue injury, embolism, dyspnea, and pain, as listed in the mitraclip system instructions for use, are known possible complications associated with mitraclip procedures.The reported hospitalization, unexpected medical interventions, and removal of foreign body were results of case-specific circumstances.There is no indication of a product quality issue with respect to manufacture, design, or labeling.Attachment: article titled ¿mitraclip single-leaflet detachment and consequent migration in atrial functional mitral regurgitation".

Event Description

This will be filed to report a single leaflet device attachment (slda) and a complete clip detachment (ccd).It was reported that a mitraclip procedure was performed to treat functional regurgitation mr grade 4.The first clip was deployed successfully.It was noted that after deployment of the second clip, the clip detached from the anterior leaflet and remained attached to the posterior leaflet (single leaflet device attachment/slda).No further treatment was provided and the procedure was concluded with a resulting mr of grade 3.Two weeks after being discharged, the patient was readmitted for inguinal pain and aggravated dyspnea.A transthoracic echocardiogram was performed and revealed recurrent mr and a small chordal rupture.An x-ray was performed and found the clip completely detached from the leaflets.A subsequent computed tomography was performed and found the clip embolized in the right common iliac artery.A percutaneous procedure was performed to retrieve the clip and a subsequent secondary mitraclip procedure was performed to treat the recurrent mr with a grade of 4.One additional clip was implanted and the procedure was concluded with a resulting mr of grade 2-3.Additional information can be found in the attached article, titled "mitraclip single-leaflet detachment and consequent migration in atrial functional mitral regurgitation.".

• Brand Name: MITRACLIP® SYSTEM CLIP DELIVERY SYSTEM
• Type of Device: VALVE REPAIR
• 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: 17033184
• MDR Text Key: 316292169
• Report Number: 2135147-2023-02371
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: P100009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/31/2023

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 Catalogue Number: UNK CDS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/08/2023
• Initial Date FDA Received: 05/31/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 84 YR
• Patient Sex: Female