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

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

Patient Problem Atrial Perforation (2511)

Event Date 01/19/2014

Event Type  Injury  

Manufacturer Narrative

Date of event: date estimated.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.Literature titled, hemodynamic patterns of residual interatrial communication after transcatheter mitraclip repair.

Event Description

This is filed to report atrial perforation.It was reported through a research article that 28 patients underwent a mitraclip procedure.30 days after the procedure, multiple patient still had an atrial septal defect present.Details are listed in the article, titled ¿hemodynamic patterns of residual interatrial communication after transcatheter mitraclip repair.¿ 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 lot and part numbers were not provided.Based on the available information, a cause for the reported atrial perforation could not be determined.The reported patient effect of atrial perforation is listed in the mitraclip system instructions for use and is a known possible complication of 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: 11170812
• MDR Text Key: 226819092
• Report Number: 2024168-2021-00443
• 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: literature
• Type of Report: Initial,Followup
• Report Date: 01/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 74 YR