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

Catalog Number UNK SGC01

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

Patient Problem Atrial Perforation (2511)

Event Date 03/15/2012

Event Type  Injury  

Manufacturer Narrative

Date of event: date estimated (udi#): in the absence of a reported part number, the udi cannot be calculated.The devices are not returning.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.The additional mitraclip devices referenced in b5 are filed under a separate medwatch report number.Literature attachment.Article title ¿prevalence and echocardiographic features of iatrogenic atrial septal defect after catheter-based mitral valve repair with the mitraclip system¿na.

Event Description

This is filed to report atrial perforation it was reported through a research article that 30 patients with mitral regurgitation underwent a mitraclip procedure and had an atrial septal defect after the procedure was completed.Within 12 months of the procedure, 8 patients had an atrial septal defect that was still present and recurrent mitral regurgitation.Details are listed in the attached article, titled ¿prevalence and echocardiographic features of iatrogenic atrial septal defect after catheter-based mitral valve repair with the mitraclip system.¿ no additional information was provided.

Manufacturer Narrative

The device was not returned for analysis.A review of the lot history record could not be performed as the part and lot information regarding the complaint device was not provided.Based on the available information, the reported atrial perforation appears to have been a result of procedural conditions.The reported patient effect of atrial perforation, as listed in the mitraclip system instructions for use, is a known possible complication associated with mitraclip procedures.There is no indication of a product quality 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: 11193532
• MDR Text Key: 227507762
• Report Number: 2024168-2021-00557
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• PMA/PMN Number: K112239
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Type of Report: Initial,Followup
• Report Date: 02/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK SGC01
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other