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

Model Number	CDS0501
Medical Device Problem Code	Incomplete Coaptation (2507)
Health Effect - Clinical Codes	Mitral Valve Insufficiency/ Regurgitation (4451); Unspecified Tissue Injury (4559)
Date of Event	08/09/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The clip remains implanted.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.Date of event: date estimated.
Event or Problem Description
This is being filed to report that the clip detached from one leaflet, recurrent mitral regurgitation (mr) and leaflet injury.It was reported that the initial mitraclip procedure was performed on (b)(6) 2017 to treat unk mitral regurgitation (mr) with a grade of 4+.One clip was implanted, reducing the mr to 3+.On an unknown date, a control echocardiogram was performed, which confirmed that the clip detached from the posterior leaflet and remained attached to the anterior leaflet (single leaflet device attachment/slda) and mr increased to 4+.It appears there may be some leaflet damage from the slda to the posterior leaflet.There is a p2 flail leaflet and flail chord but it is not certain if this was preexisting prior to the initial clip placement.The patient has been increasingly symptomatic in the last 6 months.The slda is suspected to have occurred 6-12 months after implantation according the physician.A second mitraclip procedure will be performed at a later date.No additional information was provided.
Event or Problem Description
Subsequent to the initial report filing, additional information received reporting that on (b)(6) 2021 a second mitraclip procedure was performed.Two additional clips were implanted to stabilize the slda, reducing mr from 4+ to 2.There were no issues during the procedure.The devices performed as intended.No additional information was provided.
Additional Manufacturer Narrative
The device was not returned for analysis.A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot.Additionally, a review of the complaint history identified no similar incidents reported from this lot.Based on available information, a cause for the reported single leaflet device attachment (slda) and tissue damage could not be determined.The reported mitral regurgitation (mr) was a cascading event of reported slda.The reported medical intervention and hospitalization was a result of case-specific circumstances.The reported patient effects of tissue injury and mr are listed in the instruction for use (ifu) as known possible complication associated with mitraclip procedures.There is no indication of a product issue with respect to manufacture, design, or labeling.

• Brand Name: MITRACLIP SYSTEM CLIP DELIVERY SYSTEM NT
• Common Device Name: VALVE REPAIR
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 12320728
• Report Number: 2024168-2021-07152
• Device Sequence Number: 4157993
• Product Code: NKM
• UDI-Device Identifier: 08717648216800
• UDI-Public: 08717648216800
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: P100009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/05/2021

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: 05/30/2018
• Device Model Number: CDS0501
• Device Catalogue Number: CDS0501
• Device Lot Number: 70530U115
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/28/2021
• Supplement Date Received by Manufacturer: 09/21/2021
• Initial Report FDA Received Date: 08/13/2021
• Supplement Report FDA Received Date: 10/05/2021
• 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; Required Intervention