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

Catalog Number CDS0705-NT

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

Patient Problems Thrombosis (2100); Tissue Damage (2104)

Event Date 12/18/2020

Event Type  Injury  

Manufacturer Narrative

The customer reported the device was discarded.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

This is filed to report tissue damage.It was reported that this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 3-4.The clip was implanted without issue in a3/p3.An mr jet was observed and a leaflet perforation was suspected.When the delivery catheter (dc) shaft was removed from the anatomy, tissue or thrombus was attached to the tip of the dc shaft.Since mr was reduced to 1, no additional treatment was provided.No additional information was provided.

Event Description

Subsequent to the initially filed report, the following information was received: pathological diagnosis confirmed the deposit found on the tip of the dc shaft was thrombus and not tissue.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.Tissue damage and thrombosis are listed in the instructions for use (ifu) as known possible complications associated with mitraclip procedures.Based on the available information, a cause for the reported tissue damage and thrombosis could not be determined.There is no indication of a product issue with respect to manufacture, design, or labeling.B5: description of event.

• 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: 11128380
• MDR Text Key: 225489400
• Report Number: 2024168-2021-00178
• 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: 01/21/2021

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: 08/16/2021
• Device Catalogue Number: CDS0705-NT
• Device Lot Number: 00815U267
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/18/2020
• Initial Date FDA Received: 01/06/2021
• Supplement Dates Manufacturer Received: 01/13/2021
• Supplement Dates FDA Received: 01/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: STEERABLE GUIDE CATHETER; STEERABLE GUIDE CATHETER
• Patient Outcome(s): Other