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

Model Number	CDS0501
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Mitral Regurgitation (1964)
Date of Event	04/12/2020
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 identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history did not identify any similar incidents reported from this lot.All available information was investigated and the reported migration resulting in mitral regurgitation (mr) likely appears to be related to progression of disease.The reported patient effects of patient effect of worsening mr as listed in the mitraclip system instructions for use (ifu), is a known possible complication associated with mitraclip procedures.There is no indication of a product quality issue with respect to manufacture, design or labeling.
Event or Problem Description
This is filed to report post procedure clip movement with recurrent mitral regurgitation.It was reported that the index mitraclip procedure was performed on (b)(6) 2018 to treat degenerative mitral regurgitation (mr) with grade 4+.One clip was implanted successfully, reducing mr to <1.The procedure was completed with great results.On unspecified date, the patient presented with recurrent mr grade of 4+.On (b)(6) 2020, a control echocardiogram was performed which found that a large jet was coming through the implanted clip.The clip had changed position distorting the valve possibly due to the progression of the disease.There was no tissue damage noted and the clip was noted to be stable on the leaflets.A second mitraclip procedure was discussed; however, anatomically it was not an option due to the distortion of the valve.Mitral valve replacement is being considered for a later date.No additional information was provided.

• 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: 10005754
• Report Number: 2024168-2020-03951
• Device Sequence Number: 480879
• Product Code: NKM
• UDI-Device Identifier: 08717648216800
• UDI-Public: 08717648216800
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 04/28/2020

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: 09/25/2018
• Device Model Number: CDS0501
• Device Catalogue Number: CDS0501
• Device Lot Number: 70925U295
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/13/2020
• Initial Report FDA Received Date: 04/28/2020
• 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
• Patient Age: 85 YR