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

Catalog Number SGC0302

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

Patient Problem Embolism (1829)

Event Date 09/25/2020

Event Type  Injury  

Manufacturer Narrative

The device will not be returned for evaluation; the device was reportedly discarded.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 embolism.It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 4.During insertion of the steerable guide catheter (sgc), a floating structure was observed at the septum in the left atrium (la).The sgc was removed and heparin was administered.The procedure aborted with the mr remaining at 4.There was no clinically significant delay in the procedure and no adverse patient sequela.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.Based on the available information, a cause for the reported embolism could not be determined.Additionally, embolism is listed in the mitraclip instructions for use (ifu) as a known possible complication associated with mitraclip procedures.There is no indication of a product issue with respect to manufacture, design, or labeling.

• 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: 10697493
• MDR Text Key: 211894786
• Report Number: 2024168-2020-08681
• Device Sequence Number: 1
• Product Code: DRA
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 11/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/04/2021
• Device Catalogue Number: SGC0302
• Device Lot Number: 00604U108
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention