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 Atrial Perforation (2511)

Event Date 01/06/2021

Event Type  Injury  

Manufacturer Narrative

The device will not be returned for evaluation.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 atrial septal defect.It was reported that this was a mitraclip procedure to treat mixed mitral regurgitation (mr) with a grade of 3.One clip was successfully implanted, reducing mr to 2.After retracting the steerable guide catheter (sgc) from the left atrium (la), a big right to left shunt in the septum was visible.The patient was asymptomatic.No treatment was performed.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.The reported patient effect of atrial perforation as listed in the mitraclip ntr/xtr system instructions for use (ifu), is a known possible complication associated with mitraclip procedures.Based on the information reviewed, the atrial perforation appears due to procedural conditions/user technique.There is no indication of a product issue with respect to manufacture, design, or labeling.Health effect - clinical code updated from 2511 atrial perforation to 2001 perforation.

• 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: 11229318
• MDR Text Key: 228640033
• Report Number: 2024168-2021-00605
• 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: 03/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/25/2021
• Device Catalogue Number: SGC0302
• Device Lot Number: 00925U152
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 1 IMPLANTED MITRACLIP; 1 IMPLANTED MITRACLIP
• Patient Outcome(s): Other