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

Model Number	CDS0501
Medical Device Problem Codes	Off-Label Use (1494); Incomplete Coaptation (2507)
Health Effect - Clinical Code	Tricuspid Regurgitation (2112)
Date of Event	01/17/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: date estimated.(b)(4).The device was not returned for analysis.A review of the lot history record could not be performed as the lot number is unknown.A cause for the reported single leaflet device attachment (slda) could not be determined.The reported recurrent tricuspid regurgitation (tr) appears to have been a cascading event of the reported slda.It should also be noted that per the mitraclip system instructions for use states: the mitraclip nt clip delivery system is indicated for the percutaneous reduction of significant symptomatic mitral regurgitation (mr) based on the available information, the reported off-label use was due to the device being used on a tricuspid valve.However, it cannot be confirmed in this case whether the off-label use contributed to the reported incomplete coaptation/slda and patient effects.The reported hospitalization and additional therapy/non-surgical treatment were results of case-specific circumstances, as the patient was hospitalized and an additional clip was implanted to stabilize the slda.There is no indication of a product quality issue with respect to manufacture, design or labeling.The additional device referenced is filed under a separate medwatch report number.
Event or Problem Description
This is filed to report single leaflet device attachment it was reported that on (b)(6) 2017, a mitraclip procedure was performed to treat mitral regurgitation (mr) with a grade of 4 and tricuspid regurgitation (tr) with an unknown grade.One nt clip was successfully implanted in the mitral valve reducing mr to a grade of 1.Also, one nt clip was successfully implanted in the tricuspid valve, reducing tr to an unknown grade.On an unknown date, the patient returned to the hospital symptomatic.Echocardiography was performed and showed that both mr and tr had increased.It was also noticed that the clip in the tricuspid valve had detached from one of the leaflets and remained attached to the septal leaflet (single leaflet device attachment/slda).The clip in the mitral valve remained attached to the leaflets.However, the physician did not know what caused the increased in mr.On (b)(6) 2021, a second procedure was performed to treat the increased mr and tr.In the mitral valve, valve replacement was performed.In the tricuspid valve, an additional clip was implanted to stabilize the slda.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: 11314102
• Report Number: 2024168-2021-01093
• Device Sequence Number: 13658766
• Product Code: NKM
• UDI-Device Identifier: 08717648216800
• UDI-Public: 08717648216800
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P100009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/11/2021

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 Model Number: CDS0501
• Device Catalogue Number: CDS0501
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/18/2021
• Initial Report FDA Received Date: 02/11/2021
• 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; Required Intervention