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

Catalog Number CDS0702-XTW

Device Problem Incomplete Coaptation (2507)

Patient Problems Dyspnea (1816); Mitral Valve Insufficiency/ Regurgitation (4451)

Event Date 01/17/2024

Event Type  Injury  

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 the clip detachment from the posterior leaflet, was due to pre-existing anatomy with restricted posterior leaflet, as per the physician.The reported worsening mr was a result of the slda.The reported dyspnea appears to be a secondary effect of worsening mr.The reported patient effects of mitral regurgitation and dyspnea, as listed in the mitraclip system instructions for use, are known possible complications associated with mitraclip procedures.The reported hospitalization and unexpected medical intervention were results of case-specific circumstances.There is no indication of a product quality issue with respect to manufacture, design, or labeling.

Event Description

It was reported that on (b)(6) 2023 a patient presented with grade 3 functional mitral regurgitation (mr) and an enlarged atrium for a mitraclip procedure.One mitraclip xtw was centrally implanted and the mr was reduced to grade 1-2.On (b)(6) 2024, the patient presented with dyspnea and worsened grade 4 mr.The transesophageal echocardiogram (tee) displayed a single leaflet device attachment (slda).The posterior mitral leaflet (pml) was detached.A jet can be seen medially and laterally to the index xtw.On (b)(6) 2024, a second clip intervention was performed to stabilize the slda.The first xt was implanted lateral to the xtw.The second xt was implanted medial to the xtw.After deployment, a small remaining jet appeared medially.There were no issues with procedure.The mr was reduced to grade 1-2.The patient was cardiopulmonary stable at all times.

• 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: 18731134
• MDR Text Key: 335735201
• Report Number: 2135147-2024-00727
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P100009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/19/2024

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/18/2023
• Device Catalogue Number: CDS0702-XTW
• Device Lot Number: 21216R1062
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/31/2024
• Initial Date FDA Received: 02/19/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/19/2022
• 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
• Patient Outcome(s): Required Intervention