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

Catalog Number CDS0602-XTR

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Tissue Damage (2104)

Event Date 12/11/2019

Event Type  Injury  

Manufacturer Narrative

Exemption number e2019001.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.The reported patient effect of mitral valve injury (tissue damage) as listed in the mitraclip system instructions for use, is a known possible complication associated with mitraclip procedures.Based on the information available, the reported patient effect of tissue damage appears to be due to procedural conditions.There is no indication of a product quality issue with respect to manufacture, design or labeling.The other two mitraclip devices are filed under a separate medwatch report number.

Event Description

This is filed to report tissue damage.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.

• Brand Name: MITRACLIP® SYSTEM CLIP DELIVERY SYSTEM
• Type of Device: VALVE REPAIR
• 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: 9527929
• MDR Text Key: 174901986
• Report Number: 2024168-2019-15050
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P100009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/27/2019

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: 09/27/2020
• Device Catalogue Number: CDS0602-XTR
• Device Lot Number: 90926U496
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/11/2019
• Initial Date FDA Received: 12/27/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/28/2019
• 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
• Patient Outcome(s): Other