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

Catalog Number CDS0702-XTW

Device Problem Difficult or Delayed Positioning (1157)

Patient Problems Mitral Regurgitation (1964); Tissue Damage (2104)

Event Date 01/15/2021

Event Type  Injury  

Manufacturer Narrative

The device was not returned for analysis.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

This is being filed to report the leaflet damage requiring surgery.It was reported that this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 4.One clip was successfully placed without issue.A second clip delivery system (cds) was advanced to a2p2 however a perforation of the posterior mitral leaflet (pml) occurred during the multiple grasping attempts.The clip was able to be placed slightly medial to the damage on the pml however the mr remained at 4.The patient was sent for mitral valve replacement surgery the same day.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 the reported event.A review of lot-specific similar complaints revealed no indication of a lot-specific product quality issue.Based on available information, a cause for the reported difficult or delayed positioning (leaflet grasping) could not be determined.The reported tissue damage appears to be a cascading effect of the difficult or delayed positioning.The reported mitral regurgitation (mr) appears to be a cascading effect of the tissue damage.Additionally, tissue damage and mr are listed in the instructions for use as known possible complications associated with mitraclip procedures.There is no indication of product 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: 11305242
• MDR Text Key: 231165197
• Report Number: 2024168-2021-01041
• 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: 03/04/2021

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/25/2021
• Device Catalogue Number: CDS0702-XTW
• Device Lot Number: 00925U291
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/15/2021
• Initial Date FDA Received: 02/09/2021
• Supplement Dates Manufacturer Received: 02/10/2021
• Supplement Dates FDA Received: 03/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 1 IMPLANTED MITRACLIP.; STEERABLE GUIDE CATHETER.; 1 IMPLANTED MITRACLIP; STEERABLE GUIDE CATHETER
• Patient Outcome(s): Hospitalization; Required Intervention