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); Mitral Regurgitation (1964); Mitral Valve Stenosis (1965)
Date of Event	08/01/2009
Type of Reportable Event	Death
Additional Manufacturer Narrative
Outcomes to adverse event, date of event, implant date: dates estimated.The device remains in the patient.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.Literature: percutaneous edge-to-edge mitral valve repair with the mitraclip system in barlow¿s disease.(b)(4).
Event or Problem Description
This is filed to report post mitraclip procedure, the patient had recurrent mr, mr stenosis, medical intervention and death.It was reported through literature review, that a (b)(6)-year-old female patient with barlow¿s disease underwent a mitraclip procedure to treat degenerative mitral regurgitation with grade 3 and gradient of 8 mmhg.One clip was implanted reducing mr to <1 but gradient increased to 10 mmhg.On 30-day follow-up, the patient success was mentioned as not successful.6 months later, the patient was re-hospitalized for heart failure due to recurrent mr.There was no treatment reported.On 12 months follow up, the patient had recurrent mr at 3+.There was no treatment or procedure performed.14 months later, the patient died after percutaneous mitral repair.Additional details are listed in the attached article titled, percutaneous edge-to-edge mitral valve repair with the mitraclip system in barlow¿s disease.No additional information was provided.
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
The device was not returned for analysis.A review of the lot history record could not be performed as the part and lot information regarding the complaint device was not provided.A conclusive cause for the reported patient effects of mitral regurgitation, mitral stenosis, and death could not be determined.The patient effects of recurrent mitral regurgitation, mitral stenosis, and death are listed in the mitraclip system instructions for use as known possible complications associated with mitraclip procedures.Based on the information reviewed, a conclusive cause for the reported patient effects of mitral regurgitation, mitral stenosis, and death could not be determined.Although 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.

• 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: 9872287
• Report Number: 2024168-2020-02788
• Device Sequence Number: 16882103
• 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): 07/27/2020

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: 03/24/2020; 07/20/2020
• Initial Report FDA Received Date: 03/24/2020
• Supplement Report FDA Received Date: 04/06/2020; 07/27/2020
• 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: 45 YR