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	Mitral Regurgitation (1964); Tissue Damage (2104)
Date of Event	08/01/2013
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Dates of event, tests, and implant: dates estimated.The clip remains in patient.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
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 male patient with barlow¿s disease underwent a mitraclip procedure to treat degenerative mitral regurgitation with grade 4.One clip was implanted reducing mr to 2.On 30 day and 12 months follow up, the device and procedure were a success.On last follow up (60 month) visit, the patient had recurrent mr which was treated with a second mitraclip procedure.Two additional clips were implanted.However, despite the implantation of another two clips (three clips in total) early recurrence of mr occurred due to the leaflet perforation and the patient underwent urgent mitral valve replacement.No additional information was provided.
Additional Manufacturer Narrative
The device was not returned for analysis.A review of the lot history record could not be performed as the specific lot number information was not provided.Based on the information reviewed, a definite cause for the reported patient effects of recurrent mitral regurgitation (mr) and tissue damage (leaflet perforation) could not be determined.The reported patient effect of recurrent mitral regurgitation (mr) and tissue damage as listed in the mitraclip system instructions for use, are known possible complications associated with mitraclip procedures.Here is no indication of a product quality issue with respect to manufacture, design or labeling.Part number corrected.
Additional Manufacturer Narrative
(b)(4).

• 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: 9878175
• Report Number: 2024168-2020-02852
• Device Sequence Number: 19687827
• 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: CDS02ST
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/02/2020
• Supplement Date Received by Manufacturer: 04/02/2020; 07/20/2020
• Initial Report FDA Received Date: 03/25/2020
• Supplement Report FDA Received Date: 04/17/2020; 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: Hospitalization; Required Intervention; Disability
• Patient Age: 54 YR