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

Catalog Number	CDS0701-XT
Medical Device Problem Codes	Device Damaged by Another Device (2915); Expulsion (2933); Migration (4003)
Health Effect - Clinical Codes	Embolism/Embolus (4438); Mitral Valve Insufficiency/ Regurgitation (4451)
Date of Event	08/23/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned for analysis.A review of the lot history record and complaints could not be performed as the lot information was not provided.All information was investigated, and the reported migration associated with the clip moving on the leaflets (partial clip movement) appears to be due to patient conditions (thin leaflets).The reported device damaged by another device (dislodged) and expulsion (complete clip detachment) appear to be related to procedural conditions, and due to the second clip interacting with this first implanted clip, causing expulsion of this first implanted clip.Mitral valve insufficiency/regurgitation (mr) appears to be due to the clip moving on the leaflets (migration).Additionally, the reported embolism/embolus appears to be related to the procedural conditions associated with complete clip detachment (expulsion).Mitral regurgitation and embolism are known possible complications associated with mitraclip procedures.Unexpected medical intervention, removal of foreign body and hospitalization were a result of case-specific circumstances.There is no indication of a product issue with respect to manufacture, design or labeling.The additional mitraclip device referenced in b5 is being filed under a separate medwatch report.
Event or Problem Description
This is filed to report migration, expulsion, device dislodgement, and embolism it was reported on an unknown date, a mitraclip procedure was performed to treat functional mitral regurgitation (mr) with an unknown grade.One clip was successfully implanted, reducing mr to an unknown grade.During a scheduled follow-up, echocardiography was performed and it was observed the implanted clip had moved on the leaflets, causing mr to increase to a grade of 4.On (b)(6) 2023 a second mitraclip procedure was performed, to treat the recurrent mr.While implanting an additional clip, the clip came in contact with the implanted clip, causing the implanted clip to detach from both leaflets and embolized.A snare was then inserted and the embolized clip was successfully removed.No additional information was provided.
Additional Manufacturer Narrative
The device was not returned for analysis.A review of the lot history record and complaints could not be performed as the lot information was not provided.All information was investigated, and the reported migration associated with the clip moving on the leaflets (partial clip movement) appears to be due to patient conditions (thin leaflets).The reported device damaged by another device (dislodged) and expulsion (complete clip detachment) appear to be related to procedural conditions, and due to the second clip interacting with this first implanted clip, causing expulsion of this first implanted clip.Mitral valve insufficiency/regurgitation (mr) appears to be due to the clip moving on the leaflets (migration).Additionally, the reported embolism/embolus appears to be related to the procedural conditions associated with complete clip detachment (expulsion).Mitral regurgitation and embolism are known possible complications associated with mitraclip procedures.Unexpected medical interventions, removal of foreign body and hospitalization were a result of case-specific circumstances.There is no indication of a product issue with respect to manufacture, design or labeling.

• 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: 17765677
• Report Number: 2135147-2023-04044
• Device Sequence Number: 7210202
• Product Code: NKM
• UDI-Device Identifier: 08717648230981
• UDI-Public: 08717648230981
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P100009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2023
• 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): 10/11/2023

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 Catalogue Number: CDS0701-XT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/24/2023
• Supplement Date Received by Manufacturer: 09/21/2023
• Initial Report FDA Received Date: 09/18/2023
• Supplement Report FDA Received Date: 10/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 Age: 70 YR
• Patient Sex: Male
• Patient Weight: 89 KG