MAUDE Adverse Event Report: ABBOTT VASCULAR MITRACLIP® SYSTEM CLIP DELIVERY SYSTEM; VALVE REPAIR

Model Number	CDS0201
Medical Device Problem Code	Incomplete Coaptation (2507)
Health Effect - Clinical Code	Mitral Valve Insufficiency/ Regurgitation (4451)
Date of Event	12/16/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The clip remains in the patient.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.Date of event estimated date: (b)(6) 2021.Implant date estimated date: (b)(6) 2016.
Event or Problem Description
This is filed to report the single leaflet device attachment/slda.It was reported that the initial mitraclip procedure was performed on (b)(6) 2016 (date not provided) to treat functional mitral regurgitation (mr).Two clips were implanted, reducing mr.On an unspecified date, echocardiogram was performed, imaging showed one of the clips had detached from the anterior leaflet and remained attached to the posterior leaflet (slda) and mr increased to 4.On (b)(6) 2021, a second mitraclip procedure was performed.One clip was implanted stabilizing the slda clip and reducing mr to 1.No additional information was provided.
Additional Manufacturer Narrative
The clip remains in the patient.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.Date of event estimated date: (b)(6) 2021.Implant date estimated date: (b)(6) 2016.
Event or Problem Description
This is filed to report the single leaflet device attachment/slda.It was reported that the initial mitraclip procedure was performed on (b)(6) 2016 (date not provided) to treat functional mitral regurgitation (mr).Two clips were implanted, reducing mr.On an unspecified date, echocardiogram was performed, imaging showed one of the clips had detached from the anterior leaflet and remained attached to the posterior leaflet (slda) and mr increased to 4.On (b)(6) 2021, a second mitraclip procedure was performed.One clip was implanted stabilizing the slda clip and reducing mr to 1.No additional information was provided.
Additional Manufacturer Narrative
The device was not returned for analysis.A review of the lot history record and similar complaint history was not performed as the lot number was not provided.The investigation was unable to determine a cause for the reported single leaflet device attachment (slda).The recurrent mitral regurgitation (mr) appears to be due to the procedural condition of the slda.The reported hospitalization and unexpected medical intervention were results of case-specific circumstances.Mr is listed in the instructions for use as a known possible complication associated with mitraclip procedures.There is no indication of a product issue with respect to manufacture, design, or labeling.Na.

• Brand Name: MITRACLIP® SYSTEM CLIP DELIVERY SYSTEM
• Common Device Name: VALVE REPAIR
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005070406; 3885 bohannon drive; menlo park CA 94025
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 13172672
• Report Number: 2024168-2022-00123
• Device Sequence Number: 4620518
• Product Code: NKM
• UDI-Device Identifier: 08717648195914
• UDI-Public: 08717648195914
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P100009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• 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): 01/18/2022

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 Model Number: CDS0201
• Device Catalogue Number: CDS0201
• 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: 12/16/2021
• Supplement Date Received by Manufacturer: 01/07/2022
• Initial Report FDA Received Date: 01/05/2022
• Supplement Report FDA Received Date: 01/18/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: IMPLANTED MITRACLIP(X1)
• Outcome Attributed to Adverse Event: Hospitalization; Hospitalization; Required Intervention; Required Intervention
• Patient Age: 88 YR
• Patient Sex: Male
• Patient Weight: 68 KG