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

Model Number CDS0701-XTW

Device Problems Off-Label Use (1494); Incomplete Coaptation (2507); Expulsion (2933)

Patient Problems Embolism (1829); Tricuspid Regurgitation (2112); Foreign Body In Patient (2687)

Event Date 12/01/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).The customer reported the device is not returning.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.The additional two mitraclip devices referenced are filed under a separate medwatch report number.

Event Description

This is filed to report the single leaflet device attachment (slda), complete clip detachment, embolism and valve replacement.It was reported that this was a mitraclip procedure to tricuspid regurgitation (tr) with grade 4+.Imaging was challenging due to the anatomy.The first clip delivery system (cds) (cds0701-xtw, 00917u275) was advanced to the tricuspid valve and the clip was deployed on the anterior/septal leaflets.A second cds (cds0701-xtw, 00917u272) was advanced and the clip was deployed on the posterior /septal leaflet.The procedure was completed without issue but when the patient was waking up from the anesthesia, hemodynamics changed.Echocardiogram noted that both clips had single leaflet device attachment (slda).The clips had detached from the septal leaflet and remained attached to the other leaflet.The physician decided to use a third clip.A new sgc was advanced and the third cds (cds0701-xtw, 00917u273) was advanced to the tricuspid valve.The third clip was deployed on the anterior and posterior leaflets.The procedure was completed the three clips implanted, reducing tr to 3+.The next morning, the patient¿s tr had increased to 4+, a transthoracic echocardiography (tte) and transesophageal echocardiography (tee) was performed and it showed two clips had dislodged and could not be located.The first clip remained stable on the anterior leaflet.An x-ray showed that the clips had embolized in the liver.There was no treatment performed for the two clips in the liver, but the patient did have tricuspid valve replacement on (b)(6) 2020.The patient was doing very well after the valve replacement.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 did not indicate a lot-specific issue.It should also be noted that per the mitraclip system instructions for use (ifu) states: ¿the mitraclip¿ g4 system is indicated for the percutaneous reduction of significant symptomatic mitral regurgitation (mr).The reported off-label use was due to the device being used on a tricuspid valve.Based on the available information, the reported single leaflet device attachment (slda) appears to have been a result of the reported off-label use.The reported expulsion (complete clip detachment) appears to have been a result of the reported slda.The reported recurrent tricuspid regurgitation, foreign body in patient, and embolism appear to have been cascading events of the reported expulsion (complete clip detachment).The reported poor image resolution appears to have been due to patient anatomy.Additionally, the reported patient effects of foreign body in patient and embolism are listed in the mitraclip system ifu as known possible complications associated with mitraclip procedures.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: 11049595
• MDR Text Key: 223142679
• Report Number: 2024168-2020-10780
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 08717648231001
• UDI-Public: 08717648231001
• 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: 01/15/2021

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: 09/16/2021
• Device Model Number: CDS0701-XTW
• Device Catalogue Number: CDS0701-XTW
• Device Lot Number: 00917U272
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/01/2020
• Initial Date FDA Received: 12/21/2020
• Supplement Dates Manufacturer Received: 01/06/2021
• Supplement Dates FDA Received: 01/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 2 IMPLANTED MITRACLIP
• Patient Outcome(s): Hospitalization; Required Intervention; Disability
• Patient Age: 81 YR
• Patient Weight: 85