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

Model Number	CDS0501
Medical Device Problem Code	Incomplete Coaptation (2507)
Health Effect - Clinical Codes	Dyspnea (1816); Mitral Regurgitation (1964)
Date of Event	12/27/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event - estimated.The device was not returned for analysis.A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no similar complaints reported from this lot.The reported patient effects of mitral regurgitation (mr) and dyspnea, as listed in the mitraclip system instructions for use, (ifu), are known possible complications associated with mitraclip procedures.Based on the information provided, the reported recurrent mr appears related to the single leaflet device attachment (slda) and the dyspnea was due to the recurrent mr.The investigation was unable to determine a conclusive cause for the slda.There is no indication of a product issue with respect to manufacture, design, or labeling.
Event or Problem Description
This is filed to report the single leaflet device attachment/slda.It was reported the mitraclip procedure was performed on (b)(6) 2018 to treat mixed mitral regurgitation (mr).Two clips (71011u144, 71011u130) were implanted, reducing mr from 4 to <1.Approximately 18 months later, the patient experienced dyspnea.Echocardiogram was performed, one of the implanted clips had detached from the anterior leaflet and remained attached to the posterior leaflet, (single leaflet device attachment/slda) and mr increased to 4+.No additional procedures have been planned.No additional information was provided.

• 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: 9618567
• Report Number: 2024168-2020-00842
• Device Sequence Number: 2677666
• Product Code: NKM
• UDI-Device Identifier: 08717648216800
• UDI-Public: 08717648216800
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P100009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/22/2020

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/11/2018
• Device Model Number: CDS0501
• Device Catalogue Number: CDS0501
• Device Lot Number: 71011U1NA
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/02/2020
• Initial Report FDA Received Date: 01/22/2020
• 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: Other