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

Catalog Number UNK CDS

Device Problem Off-Label Use (1494)

Patient Problems Tissue Damage (2104); Tricuspid Regurgitation (2112)

Event Date 10/01/2017

Event Type  Injury  

Manufacturer Narrative

Date of event, implant date: estimated dates.The clip remains in the patient.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.Literature titled, comparison of transcatheter tricuspid valverepair using the mitraclip ntr and xtr systems.

Event Description

This is filed to report recurrent tricuspid regurgitation, and tissue damage.It was reported through a research article identifying mitraclip devices that were implanted for off-label use that were related to the following outcomes: recurrent tricuspid regurgitation and tissue damage.Specific patient information is documented as unknown.Details are listed in the article, titled comparison of transcatheter tricuspid valver epair using the mitraclip ntr and xtr systems.¿ no additional information was provided.

Manufacturer Narrative

The devices were not returned for analysis and a review of the lot history record review could not be performed as the part and lot information regarding the complaint device was not provided.The similar complaint review was not performed because there was no device malfunction reported and this complaint was based on an article review with no device/lot information provided.The reported off-label use of the device was associated with the procedure being performed on the tricuspid valve.It should be noted that the mitraclip instructions for use (ifu) states under the "intended use" section that "the mitraclip ntr/xtr system is intended for reconstruction of the insufficient mitral valve through tissue approximation." as it was reported that the mitraclip device was used on the tricuspid valve, this is considered off-label use of the device.However, it cannot be determined whether the ifu deviation contributed to the reported patient effects.Based on the information provided, the reported tissue damage appears to be related to procedural conditions associated.It is likely the reported tricuspid regurgitation/tr was either an outcome of tissue damage or otherwise related to disease progression/patient condition.The patient effects of tissue damage, and tr are listed in the instructions for use (ifu) as known possible complications associated with mitraclip procedures.There is no indication of a product issue with respect to manufacture, design or labeling.

• Brand Name: MITRACLIP SYSTEM CLIP DELIVERY SYSTEM
• Type of Device: VALVE REPAIR
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 11131648
• MDR Text Key: 225521866
• Report Number: 2024168-2021-00192
• 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: 03/10/2021

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
• Device Operator: Health Professional
• Device Catalogue Number: UNK CDS
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/15/2020
• Initial Date FDA Received: 01/07/2021
• Supplement Dates Manufacturer Received: 02/13/2021
• Supplement Dates FDA Received: 03/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other