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 Cardiogenic Shock (2262); Mitral Valve Insufficiency/ Regurgitation (4451)

Event Date 09/19/2023

Event Type  Death  

Event Description

It was reported on (b)(6) 2023, a mitraclip procedure was performed to treat mitral regurgitation (mr).One clip was implanted, reducing mr.On (b)(6) 2023, the patient returned to the hospital with a symptom of cardiogenic shock.Echocardiography showed the implanted clip detached from the posterior leaflet and remained attached to the anterior leaflet (single leaflet device attachment/slda), causing mr to return to a grade of 4+.On (b)(6) 2023, the patient died.No additional information was provided.

Manufacturer Narrative

The clip remains in the patient.The device will not be returned for evaluation.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.Na.

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, a cause of the reported incomplete coaptation (slda, single leaflet device attachment), associated with clip detachment from the posterior leaflet, could not be determined.The reported worsening mr and cardiogenic shock appear to be results of the slda.The reported death appears to be due to the patient suffering from a cardiogenic shock.The reported patient effects of death, cardiogenic shock, and mitral regurgitation, as listed in the mitraclip system instructions for use, are known possible complications associated with mitraclip procedures.The reported hospitalization was a result 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 patient¿s death appears to be due to acute severe mr and cardiogenic due to an slda which occurred about 9 days after mitral transcatheter edge-to-edge repair (mteer) for fmr.No other clinical data was provided and images were not available to review due to national patient record regulations.".

Event Description

It was reported on (b)(6) 2023, a mitraclip procedure was performed to treat functional mitral regurgitation (mr) with a grade of 3-4.One xtw clip was implanted, reducing mr to a grade of 1-2.On (b)(6) 2023, the patient returned to the hospital with a symptom of cardiogenic shock.Echocardiography showed the implanted clip detached from the posterior leaflet and remained attached to the anterior leaflet (single leaflet device attachment/slda), causing mr to worsen to a grade of 4+.On (b)(6) 2023, the patient died.

• 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: 18330092
• MDR Text Key: 330521656
• Report Number: 2135147-2023-05527
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• Reporter Country Code: BE
• 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: 02/14/2024

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: CDS0702-XTW
• Device Lot Number: 30614R1080
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/21/2023
• Initial Date FDA Received: 12/14/2023
• Supplement Dates Manufacturer Received: 02/05/2024
• Supplement Dates FDA Received: 02/14/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/15/2023
• 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
• Patient Outcome(s): Death