MAUDE Adverse Event Report: ABBOTT VASCULAR MITRACLIP XTR 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

The udi is unknown because the part number and lot number were not provided.The device was not returned for analysis and a review of the lot history record could not be performed as the part and lot information regarding the complaint device was not provided.Based on the available information, a cause for the reported single leaflet device attachment/slda could not be determined.A cause for the reported patient effect of recurrent tricuspid regurgitation (tr) could not be determined.The reported patient effect of recurrent tr is listed in the mitraclip system instructions for use (ifu), and is a known possible complication associated with mitraclip procedures.The reported additional therapy/non-surgical treatment was a result of case-specific circumstances.It should also be noted that the mitraclip ifu states: ¿do not use mitraclip outside of the labeled indication¿.Since mitraclip was used for a tricuspid valve procedure, this is considered as an off-label use of the device.However, it could not be determined if using the mitraclip on the tricuspid valve caused or contributed to the reported events.There is no indication of a product quality issue with respect to manufacture, design or labeling.Article titled, "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 xtr 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).A 30-day follow up revealed that the patient had recurrent tr which was treated through medical management.No additional information was provided.

• Brand Name: MITRACLIP XTR CLIP DELIVERY SYSTEM
• Type of Device: VALVE REPAIR
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005070406; 3885 bohannon drive; menlo park CA 94025
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 11132708
• MDR Text Key: 225575058
• Report Number: 2024168-2021-00222
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P100009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/07/2021

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/15/2020
• Initial Date FDA Received: 01/07/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention