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

Model Number CDS0701-XTW

Device Problem Incomplete Coaptation (2507)

Patient Problems Dyspnea (1816); Edema (1820); Mitral Regurgitation (1964)

Event Date 05/13/2020

Event Type  Injury  

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.The additional mitraclip delivery system referenced are filed under separate medwatch report number.

Event Description

This is filed to report the single leaflet device attachment of the index mitraclip.It was reported that on (b)(6) 2020 this was a mitraclip procedure to treat grade 4 degenerative mitral regurgitation (mr) in the patient with a large posterior flail and very thick mitral valve leaflets.Two mitraclips were implanted.On (b)(6) 2020 the patient had shortness of breath, edema, and recurrent mr grade 4.One of the original mitraclips was noted to only be attached to the anterior leaflet.The posterior leaflet had come out of the mitraclip.A redo mitraclip procedure was performed.On (b)(6) 2020 the first mitraclip was implanted.During removal of the lock line the posterior leaflet came out of the mitraclip.Imaging was difficult during the redo procedure due to the shadowing created from the two index clips.The physician suspected that although there appeared to be enough leaflet, in retrospect, it is possible that there was not enough posterior leaflet inside the clip.A second mitraclip was implanted to stabilize the first clip.Mr was reduced to grade 1.No additional information was provided.

Manufacturer Narrative

The device was not returned for analysis as it remains implanted.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event and a review of the complaint history identified no similar incident reported from this lot.Based on all available information, the reported slda (single leaflet device attachment) appears to be due to challenging patient anatomy as the physician stated that the reported slda was due to the leaflets not being grabbed enough due to challenging patient anatomy (large flail on p2 and very thick mitral valve leaflets.).Additionally, the reported dyspnea, edema and mitral regurgitation were cascading effects of the reported slda.The reported patient effect of dyspnea, edema and mitral regurgitation are listed in the mitraclip ntr/xtr instructions for use as known possible complications associated with mitraclip procedures.There is no indication of a product issue with respect to manufacture, design, or labeling.

• Brand Name: G4 MITRACLIP 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: 10119010
• MDR Text Key: 194004872
• Report Number: 2024168-2020-04750
• 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: 07/06/2020

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: 04/24/2020
• Device Model Number: CDS0701-XTW
• Device Catalogue Number: CDS0701-XTW
• Device Lot Number: 91023U129
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/13/2020
• Initial Date FDA Received: 06/04/2020
• Supplement Dates Manufacturer Received: 06/12/2020
• Supplement Dates FDA Received: 07/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: OTHER INDEX CLIP.; OTHER INDEX CLIP
• Patient Outcome(s): Hospitalization; Required Intervention