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

Catalog Number UNK CDS06

Device Problems Off-Label Use (1494); Incomplete Coaptation (2507)

Patient Problem Tricuspid Regurgitation (2112)

Event Date 09/01/2017

Event Type  Injury  

Manufacturer Narrative

Date of event/ implant date: estimated dates.(b)(4).The clip remains in the patient.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.Literature.Article title ¿comparison of transcatheter tricuspid valve repair using the mitraclip ntr and xtr systems¿.

Event Description

This is filed to report recurrent tricuspid regurgitation, single leaflet device attachment/ slda), medical intervention, it was reported in an article review that this was a mitraclip procedure to treat tricuspid regurgitation (tr).An ntr clip delivery system (cds) was advanced to the tricuspid valve for off label use, and the clip was deployed.However, the clip became detached from one leaflet, but remained attached to the other leaflet (single leaflet device attachment/ slda) due to challenging imaging.A 30-day follow up revealed that the patient had recurrent tr which was treated through medical management.No additional information was provided.

Manufacturer Narrative

The udi is unknown because the part number and lot number were not provided.The device was not returned for analysis.Reviews of the lot history record and of similar complaints could not be performed as lot and part numbers were not provided.Based on the available information, the single leaflet device attachment/slda appears to be due to procedural conditions.A cause for the reported poor imaging could not be determined.The reported tricuspid regurgitation (tr) appears to be a cascading event of the slda.The reported additional therapy/non-surgical treatment was a result of case-specific circumstances.It should be noted that per the mitraclip system instructions for use states: ¿the mitraclip system is indicated for the percutaneous reduction of significant symptomatic degenerative mitral regurgitation (mr).¿ since the mitraclip device was implanted on a tricuspid valve, this is considered as an off-label use of the device.However, the off-label use does not appear to have contributed to the reported patient effects.There is no indication of a product issue with respect to manufacture, design, or labeling.Na.

• Brand Name: MITRACLIP NTR CLIP DELIVERY SYSTEM
• Type of Device: VALVE REPAIR
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 11131486
• MDR Text Key: 225519284
• Report Number: 2024168-2021-00188
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• PMA/PMN Number: P100009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Type of Report: Initial,Followup
• Report Date: 01/21/2021

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK CDS06
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/15/2020
• Initial Date FDA Received: 01/07/2021
• Supplement Dates Manufacturer Received: 01/15/2021
• Supplement Dates FDA Received: 01/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention