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

Catalog Number CDS0602-XTR

Device Problems Off-Label Use (1494); Migration (4003)

Patient Problems Tricuspid Regurgitation (2112); Heart Failure (2206)

Event Date 09/26/2020

Event Type  Injury  

Manufacturer Narrative

(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.

Event Description

It was reported that on (b)(6) 2020, a mitraclip procedure was performed to treat tricuspid regurgitation (tr) with a grade of 5.One xt clip (91226u124) was successfully implanted on the anterior and septal leaflets, reducing tr to a grade of 3.On (b)(6) 2020, the patient returned to patient returned to the hospital due to heart failure symptoms.Transesphagael echocardiography (tee) was performed and showed the tr and increased to a grade of 4 and the implanted xt clip had partially detached from the anterior leaflet.To reduce tr and stabilize the partially detached clip, a triclip was successfully implanted, reducing tr to a grade of 2.On (b)(6) 2020, the patient returned to the hospital and tee showed that tr had increased to a grade of 3.It was noted that both clips were stable on the leaflets.The following day, an additional triclip was successfully implanted, reducing tr to a grade of 1.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 similar incidents reported from this lot.Based on the available information, a cause for the reported partial clip movement could not be determined.The reported recurrent tricuspid regurgitation (tr) and heart failure appear to have been cascading events of the reported partial clip movement.Additionally, the reported patient effect of heart failure is listed in the mitraclip system instructions for use as a known possible complication associated with mitraclip procedures.The reported additional therapy/non-surgical treatment and hospitalization were results of case-specific circumstances, as the patient underwent prolonged hospitalization due to heart failure and an additional clip was implanted to stabilize the partially detached clip.It should be noted that per the mitraclip system instructions for use states: ¿the mitraclip system is intended for reconstruction of the insufficient mitral valve through tissue approximation¿.Since the mitraclip device was implanted on a tricuspid valve, this is considered as an off-label use of the device.However, it could not be determined whether using mitraclip on the tricuspid valve caused or contributed to the reported migration (partial clip movement).There is no indication of a product quality issue with respect to manufacture, design or labeling.

• Brand Name: MITRACLIP XTR CLIP DELIVERY SYSTEM
• Type of Device: VALVE REPAIR
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 11066153
• MDR Text Key: 223429912
• Report Number: 2024168-2020-10900
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/14/2021

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 Expiration Date: 01/01/2021
• Device Catalogue Number: CDS0602-XTR
• Device Lot Number: 91226U124
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/02/2020
• Initial Date FDA Received: 12/23/2020
• Supplement Dates Manufacturer Received: 01/05/2021
• Supplement Dates FDA Received: 01/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention