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 Codes	Death (1802); Myocardial Infarction (1969)
Date of Event	12/01/2009
Type of Reportable Event	Death
Additional Manufacturer Narrative
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.Article titled: percutaneous edge to edge mitral valve repair with the mitraclip system in barlows disease.(b)(4).
Event or Problem Description
This is filed to report post mitraclip procedure, the patient died due to myocardial infarction.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 62-year-old male patient with barlow¿s disease underwent a mitraclip procedure to treat degenerative mitral regurgitation (mr) with grade 4.Two clips were implanted reducing mr to <1.On 30-day follow-up, the patient was reported as optimal success.4 months later, the patient died due to myocardial infarction.Additional details are included in the attached article.No additional information was provided.
Additional Manufacturer Narrative
This report is being resubmitted to ensure the enclosed attachment can be easily opened by the fda.(b)(4).
Additional Manufacturer Narrative
The device was not returned for analysis.A review of the lot history record could not be performed as this incident was based on an article review and no lot information was provided.Based on all available information, the reported death appears to be due to the reported myocardial infarction.However, a definitive cause for the reported myocardial infarction could not be determined.The reported patient effects of death and myocardial infarction are listed in the mitraclip system instructions for use (ifu) as known possible complications associated with mitraclip procedures.Although, a conclusive cause for the reported patient effects, and the relationship to the device, if any, cannot be determined, 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
• MDR Report Key: 9872401
• Report Number: 2024168-2020-02792
• Device Sequence Number: 2952452
• 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: 2008
• Reporter Type: Manufacturer
• Report Source: literature
• 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: CDS0201
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/02/2020
• Supplement Date Received by Manufacturer: 05/13/2020; 07/20/2020
• Initial Report FDA Received Date: 03/24/2020
• Supplement Report FDA Received Date: 06/02/2020; 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: Death
• Patient Age: 62 YR