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

Catalog Number CDS0602-XTR

Device Problem Unintended Movement (3026)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/11/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.The other two mitraclip devices referenced are filed under a separate medwatch report number.

Event Description

This is filed to report the clip opened during the final arm angle test.It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 4+.The first clip delivery system (cds 90926u451) was advanced to the mitral valve.The final arm angle (efaa) test failed, the clip opened to 50-60 degrees.The sixth efaa attempt was successful; however, the decision was made to not implant the clip and the cds was removed.A second cds (90926u452) was advanced and the clip was placed.However, during the efaa test the clip slightly opened 20-25 degrees.Leaflet insertion was still very good, therefore the clip was implanted.After deployment, the clip opened more than prior to deployment, but remained secure on the leaflets.A third clip (90926u496) was advanced to further reduce mr; after the leaflets were grasped, the posterior leaflet tore.The clip was implanted; mr was reduced to 3-4.The patient was hemodynamically stable and was extubated without any problems.No additional information was provided.

Manufacturer Narrative

The device was returned and investigated.The reported unintended movement (clip open ¿ during establishing final arm angle (efaa)) was not confirmed during returned device analysis as the device performed as indicated.A review of the lot history record revealed no manufacturing nonconformities to the reported lot that would have contributed to this event.Additionally, a review of the complaint history did not identify a lot specific quality issue.All available information was investigated, a definitive cause for the reported unintended movement could not be determined.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• Brand Name: MITRACLIP® SYSTEM CLIP DELIVERY SYSTEM
• Type of Device: VALVE REPAIR
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9527916
• MDR Text Key: 173057596
• Report Number: 2024168-2019-15047
• 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: 02/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/27/2020
• Device Catalogue Number: CDS0602-XTR
• Device Lot Number: 90926U451
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2020
• Initial Date Manufacturer Received: 12/11/2019
• Initial Date FDA Received: 12/27/2019
• Supplement Dates Manufacturer Received: 01/23/2020
• Supplement Dates FDA Received: 02/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: STEERABLE GUIDE CATHETER; STEERABLE GUIDE CATHETER