MAUDE Adverse Event Report: ABBOTT VASCULAR MITRACLIP G4 CLIP DELIVERY SYSTEM; MITRAL VALVE REPAIR DEVICES

Model Number CDS0701-XT

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

Patient Problem Tricuspid Regurgitation (2112)

Event Date 12/31/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).The clip remains in patient.The device will not be returned for evaluation.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

This is filed to report post procedure,a single leaflet device attachment and recurrent mr occurred.It was reported that this was a mitraclip procedure on 12/30/2020 to treat tricuspid regurgitation (tr) with grade 4+.One clip was implanted on the anterior and septal leaflets, reducing tr to 2.Imaging was poor during the procedure.The next day, the transthoracic echocardiography showed tr returned to a grade 4.A single leaflet device attachment was noted.There was no tissue damage noted.There was no additional treatment performed or planned.No additional information was provided.

Manufacturer Narrative

The device was not returned for analysis.A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other incidents reported from this lot.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 result of the slda.A cause for the reported poor imaging could not be determined.It should be noted that per the mitraclip system instructions for use states: ¿the mitraclip¿ g4 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 if the off-label use contributed to the reported slda.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• Brand Name: MITRACLIP G4 CLIP DELIVERY SYSTEM
• Type of Device: MITRAL VALVE REPAIR DEVICES
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 11164399
• MDR Text Key: 226619929
• Report Number: 2024168-2021-00404
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 08717648230981
• UDI-Public: 08717648230981
• Combination Product (y/n): N
• PMA/PMN Number: P100009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/19/2021

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 Expiration Date: 08/18/2021
• Device Model Number: CDS0701-XT
• Device Catalogue Number: CDS0701-XT
• Device Lot Number: 00818U231
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/31/2020
• Initial Date FDA Received: 01/13/2021
• Supplement Dates Manufacturer Received: 01/13/2021
• Supplement Dates FDA Received: 01/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other