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

Model Number	CDS0201
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Mitral Regurgitation (1964)
Date of Event	08/01/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Dates of event, tests, and implant: dates estimated.The clip remains in 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.
Event or Problem Description
This is filed to report post mitraclip procedure, the patient had recurrent mitral regurgitation.This event was captured based on a review of the article, percutaneous edge to edge mitral valve repair with the mitraclip system in barlows disease.It was reported that a (b)(6)-year-old female patient with barlow¿s disease underwent a mitraclip procedure to treat degenerative mitral regurgitation with grade 3.One clip was implanted reducing mr to 1.On 30 day the device and procedure were a success.On 12 months follow up, the patient had recurrent mr.There was no treatment or procedure performed.No additional information was provided.
Additional Manufacturer Narrative
The devices were not returned for analysis and a review of the lot history record and similar complaint review could not be performed as the part and lot information regarding the complaint device was not provided.Based on the information provided a conclusive cause for the reported recurrent mitral regurgitation cannot be determined.The reported patient effects of recurrent mitral regurgitation, as listed in the mitraclip system instructions for use (ifu), is a known possible complication associated with mitraclip procedures.Based on the information provided a conclusive cause for the reported recurrent mr cannot be determined.There is no indication of a product issue with respect to manufacture, design, or labeling.Other serious removed catalog number corrected, udi number corrected.
Additional Manufacturer Narrative
This report is being resubmitted to ensure the enclosed attachment can be easily opened by the fda.

• Brand Name: MITRACLIP SYSTEM CLIP DELIVERY SYSTEM
• Common Device Name: VALVE REPAIR
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9875681
• Report Number: 2024168-2020-02823
• Device Sequence Number: 14180652
• Product Code: NKM
• UDI-Device Identifier: 08717648195914
• UDI-Public: 08717648195914
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: P100009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/29/2020

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?: No
• Operator of Device: Health Professional
• Device Model Number: CDS0201
• Device Catalogue Number: CDS02ST
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/02/2020
• Supplement Date Received by Manufacturer: 04/11/2020; 07/20/2020
• Initial Report FDA Received Date: 03/24/2020
• Supplement Report FDA Received Date: 04/29/2020; 07/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Other
• Patient Age: 51 YR