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

Model Number CDS0701-XT

Device Problem Off-Label Use (1494)

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

Event Date 12/17/2020

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.The additional device referenced is filed under a separate medwatch report number.

Event Description

This is being filed to report the clip causing damage to the leaflet and increased tr.It was reported that the initial mitraclip procedure was performed on (b)(6) 2020, to treat tricuspid regurgitation (tr) with a grade of 4+.Patient was severely diuresed before procedure to lessen coaptation gap of tr.Three clips were implanted, reducing tr to 1.The patient returned on a later date and transesophageal echocardiography (tee) observed the tr had increased to 4 and that two of the clips had torn through the anterior leaflet.The clip were still attached to both leaflets.According to the physician, after the patient¿s procedure, the patient was given fluid volume on the floor and became volume overloaded.The thought was that because they were diuresed prior, the overload of volume put too much immediate stress on leaflets causing a tear.No further treatment was 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.It should be noted that per the mitraclip system instructions for use (ifu), indication for use section states: the mitraclip g4 system is indicated for the percutaneous reduction of significant symptomatic mitral regurgitation.The off-label use does not appear to have contributed to the reported patient effects.The reported patient effect of tissue damage appears to have been a result of procedural conditions.The reported patient effect of recurrent tr appears to have been a cascading event of the reported tissue damage.Additionally, the reported patient effect of tissue damage as listed in the mitraclip system instructions for use, is a known possible complication 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: 11135280
• MDR Text Key: 225733036
• Report Number: 2024168-2021-00237
• 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: 01/12/2021

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: 08/17/2021
• Device Model Number: CDS0701-XT
• Device Catalogue Number: CDS0701-XT
• Device Lot Number: 00818U104
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/17/2020
• Initial Date FDA Received: 01/07/2021
• Supplement Dates Manufacturer Received: 01/08/2021
• Supplement Dates FDA Received: 01/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 2 IMPLANTED MITRACLIPS
• Patient Outcome(s): Other
• Patient Age: 97 YR
• Patient Weight: 67