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 Code	Mitral Regurgitation (1964)
Date of Event	02/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event - estimated.Implant date - estimated.The clip remains in the patient and will not be returned for evaluation.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
This is filed to report the single leaflet device attachment (slda).It was reported that the mitraclip procedure was performed on an unspecified date, approximately 2 years ago, to treat grade 4 degenerative mitral regurgitation (mr).One clip was implanted, reducing mr to grade 2.The procedure was successful, and the patient had a good outcome.In (b)(6) 2020, echocardiogram was performed.The clip detached from the posterior leaflet and remained attached to the anterior leaflet, (slda) and mr increased to 4.The patient remains asymptomatic and is pending another evaluation.No additional information was provided.
Additional Manufacturer Narrative
The device was not returned for analysis.A review of the lot history record and the complaint history could not be performed because the lot number was not provided.The reported patient effect of worsening mitral regurgitation (mr) as listed in the instructions for use is a known possible complication associated with mitraclip procedures.Based on the information reviewed, the reported single leaflet device attachment (slda) was likely caused by challenging patient anatomy.The mr appears to be an outcome of the slda.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: 10617665
• Report Number: 2024168-2020-08202
• Device Sequence Number: 14386411
• Product Code: NKM
• UDI-Device Identifier: 08717648216800
• UDI-Public: 08717648216800
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• 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,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/17/2020

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 Model Number: CDS0501
• Device Catalogue Number: CDS0501
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/09/2020
• Supplement Date Received by Manufacturer: 10/30/2020
• Initial Report FDA Received Date: 10/01/2020
• Supplement Report FDA Received Date: 11/17/2020
• 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