MAUDE Adverse Event Report: ABBOTT VASCULAR MITRACLIP SYSTEM STEERABLE GUIDE CATHETER; VALVE REPAIR

Model Number SGC0301

Device Problem Failure to Advance (2524)

Patient Problems Perforation (2001); Cardiac Tamponade (2226)

Event Date 09/21/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

This is filed to report the perforation.It was reported this was a mitraclip procedure performed to treat degenerative mitral regurgitation (mr) with a grade of 4+.During advancement of the steerable guide catheter (sgc) just a few centimeters into the femoral vein, resistance was felt with the stenotic vessel and a vein perforation was noted.The sgc was removed without issue.A vascular surgeon was called, and balloon tamponade was performed, followed by stent implantation, resolving the perforation.The mitraclip procedure was aborted.No clips were implanted, mr remained 4+.Per the physician, it cannot be said for certain which device caused the injury to the vein.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.Additionally, a review of the complaint history identified no similar incidents reported from this lot.The reported patient effect of perforation as listed in the instructions for use, is a known possible complication associated with mitraclip procedures.Based on the information reviewed, the reported failure to advance-septum appears to be due to challenging patient anatomy (stenotic vessel).The cause for the reported patient effect of perforation could not be determined.The additional therapy non-surgical treatment was a result of case specific circumstances.There is no indication of a product issue with respect to manufacture, design, or labeling.Patient code 2226 - removed.

• Brand Name: MITRACLIP SYSTEM STEERABLE GUIDE CATHETER
• Type of Device: VALVE REPAIR
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 10680937
• MDR Text Key: 211437827
• Report Number: 2024168-2020-08606
• Device Sequence Number: 1
• Product Code: DRA
• UDI-Device Identifier: 08717648216824
• UDI-Public: 08717648216824
• Combination Product (y/n): N
• PMA/PMN Number: K161985
• 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: 12/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/16/2021
• Device Model Number: SGC0301
• Device Catalogue Number: SGC0301
• Device Lot Number: 00616U257
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention