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

Catalog Number CDS0705-NT

Device Problem Positioning Failure (1158)

Patient Problems Arrhythmia (1721); Unspecified Tissue Injury (4559)

Event Date 11/24/2023

Event Type  Death  

Event Description

It was reported that a mitraclip procedure was performed to treat mitral regurgitation (mr).An xtw mitraclip was implanted near an indentation on the posterior leaflet, but shortly after implantation, the indentation opened into a cleft.Mr so far had been reduced to grade 2-3.An additional mitraclip nt and mitraclip xtw clips were then attempted to be implanted but could not grasp the leaflets.The xtw was able to grasp in one area but it resulted in no mr reduction.The grasping with the nt and xtw clips lead to leaflet damage and worsening mr.The leaflets started to look ¿ragged¿ on transesophageal echocardiogram (tee) imaging, pulmonary veins showed reversal.The procedure was abandoned.The patient remains hospitalized in a frail state.No additional information was provided.

Manufacturer Narrative

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

Manufacturer Narrative

B2 - date of death is estimated.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.H6 - health effect - clinical code 1721 added h6 - health effect - impact code 1802 added.

Event Description

Subsequent to the previously filed report, additional information was received: the patient remained hospitalized in a frail state and was discharged home one week after the procedure.One week after returning home, the patient passed away.The cause of death was presumed arrhythmia.No additional information was provided.

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 identified no similar complaints reported from this lot.The investigation determined the reported inability to grasp the leaflets appears to be related to patient and procedural condition due to cleft opened after implantation.The reported tissue injury (leaflet damaged) appears to be due to multiple grasping attempt due to the inability to grasp.A cause for the reported death and arrhythmia cannot be determined.Death, tissue injury, and arrhythmia are listed in the instructions for use as known possible complications associated with mitraclip procedures.The reported hospitalization was a results of case specific circumstance as the patient remained hospitalized due to the patient effects.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: 18343710
• MDR Text Key: 330667377
• Report Number: 2135147-2023-05551
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• Reporter Country Code: SN
• 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,Followup
• Report Date: 02/12/2024

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: 03/11/2024
• Device Catalogue Number: CDS0705-NT
• Device Lot Number: 30313R1078
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/24/2023
• Initial Date FDA Received: 12/18/2023
• Supplement Dates Manufacturer Received: 12/15/2023; 01/23/2024
• Supplement Dates FDA Received: 12/19/2023; 02/12/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/13/2023
• 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; Other
• Patient Age: 85 YR