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

Model Number	CDS0701-NTW
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	Mitral Valve Insufficiency/ Regurgitation (4451)
Date of Event	05/01/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
This will be filed to report a clip that opened while locked.It was reported that on (b)(6) 2021 a mitraclip procedure was performed to treat functional mitral regurgitation (mr) grade 4.One clip was implanted and the mr was reduced to grade 1.Roughly 18 months later, the patient returned to the hospital.Transesophageal echocardiography (tee) was performed and it was observed the clip had slightly opened, causing mr to increase to a grade of 3-4.On (b)(6) 2023 a second mitraclip procedure was performed.An additional clip was then implanted, reducing mr to a grade of 1.No additional information was provided.
Additional 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.B3: date of event is estimated.
Additional 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.Based on available information, the reported mitral valve insufficiency/ regurgitation (recurrent mr) associated with mr increasing to 3-4 appears to be due to the clip opening while locked (cowl).The cause of the reported unintended movement (clip open - locked) associated with the cowl could not be determined.The reported patient effect of mitral regurgitation, as listed in the mitraclip system instructions for use (ifu), is a known possible complication associated with mitraclip procedures.The reported unexpected medical intervention and hospitalization were results of case-specific circumstances.There is no indication of a product quality issue with respect to manufacture, design, or labeling.This event was reviewed by a staff engineer clinical r&d, and the reviewer stated ¿one fluoroscopic still image of the reported clip was provided.A single, fully deployed clip can be visualized.It was reported that the initial procedure was performed on (b)(6) 2021 in which one clip (reported device) was implanted.On (b)(6) 2023 a second mitraclip procedure was performed to treat degenerative recurrent mr grade 3-4 due to the previously implanted clip opening.To this end, it is assumed the provided image was taken of the reported clip post procedurally, likely months after the initial procedure.The clip arm angle appears to be ~20°; this is an estimation based on visual assessment with the naked eye and is not confirmed.However, the clip does not present a significant clip arm angle.Per the instructions for use, the user closes the clip until the clip arms form a distinct "v" shape (fully closed) which is presented in the image provided.No pre-deployment cine of the reported clip was provided; as such, no assessment or comment regarding the pre-deployment state of the clip (clip arm angle prior to dc detachment), when and/or by how much the clip opened, can be made.There are no additional observations based on the image provided.¿.

• Brand Name: MITRACLIP G4 CLIP DELIVERY SYSTEM (MDD)
• Common Device Name: 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: 17007726
• Report Number: 2135147-2023-02330
• Device Sequence Number: 20418889
• Product Code: NKM
• UDI-Device Identifier: 08717648230967
• UDI-Public: 08717648230967
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P100009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/17/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/18/2022
• Device Model Number: CDS0701-NTW
• Device Catalogue Number: CDS0701-NTW
• Device Lot Number: 10619R194
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/02/2023
• Supplement Date Received by Manufacturer: 06/26/2023
• Initial Report FDA Received Date: 05/25/2023
• Supplement Report FDA Received Date: 07/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/19/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown