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)

Patient Problems Mitral Valve Insufficiency/ Regurgitation (4451); Tricuspid Valve Insufficiency/ Regurgitation (4453)

Event Date 12/09/2021

Event Type  Injury  

Event Description

This is filed to report the single leaflet device attachment (slda) requiring an additional clip for stabilization.It was reported that this was a mitraclip procedure to treat tricuspid regurgitation (tr) with grade of 4.The clip delivery system (cds) was advanced to the tricuspid valve and the clip was implanted.After the clip was deployed, the clip detached from the septal leaflet and remained attached to the posterior leaflet (single leaflet device attachment/slda).An additional clip was attempted to be deployed to stabilize the slda but was not able to be placed due to very difficult imaging throughout the entire case.Tr remained at 4.No additional information was provided.

Manufacturer Narrative

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

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.A review of lot-specific similar complaints did not indicate a lot-specific quality issue.Based on the available information, the reported single leaflet device attachment (slda) appears to be due to challenging patient anatomy.It should be noted that the mitraclip g4 system instructions for use (ifu) states: ¿the mitraclip¿ g4 system is indicated for the percutaneous reduction of significant symptomatic mitral regurgitation (mr).Since the mitraclip device was implanted on the tricuspid valve, this is considered as an off-label use of the device.However, the off-label use did not appear to contribute to the reported slda.The poor image resolution was due to challenging patient anatomy.The reported tricuspid regurgitation (tr) appears to be a cascading event of the slda.The reported unexpected medical intervention was the result of case-specific circumstances.There is no indication of a product issue with respect to manufacture, design, or labeling.H6.Health effect - clinical code 4451 removed.

• 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
• 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: 13098782
• MDR Text Key: 288025571
• Report Number: 2024168-2021-12232
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 08717648231001
• UDI-Public: 08717648231001
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/08/2022

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: 06/04/2022
• Device Model Number: CDS0701-XTW
• Device Catalogue Number: CDS0701-XTW
• Device Lot Number: 10605R140
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/09/2021
• Initial Date FDA Received: 12/28/2021
• Supplement Dates Manufacturer Received: 01/28/2022
• Supplement Dates FDA Received: 02/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/05/2021
• 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
• Treatment: STEERABLE GUIDE CATHETER
• Patient Outcome(s): Required Intervention