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

Catalog Number SGC0302

Device Problem Off-Label Use (1494)

Patient Problem Atrial Perforation (2511)

Event Date 08/14/2020

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.(b)(4).

Event Description

This is being filed to report the atrial septal defect requiring intervention.It was reported that this was a mitraclip procedure to treat tricuspid regurgitation (tr) with a grade of 3.One clip was implanted, reducing tr to 1-2.After the clip delivery system (cds) was removed, it was noted there was an atrial septal defect (asd).An occluder was placed to treat the asd.There was no clinically significant delay in the procedure and no adverse patient effects.No additional information was provided.

Manufacturer Narrative

The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot.Based on the available information, the reported atrial perforation was due to procedural conditions.It should be noted that the mitraclip ifu states: the mitraclip nt system is intended for reconstruction of the insufficient mitral valve through tissue approximation.The off-label use does not appear to have contributed to the reported issue.The reported patient effect of atrial septal defect requiring intervention as listed in the mitraclip nt system instructions for use (ifu), 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: 10488057
• MDR Text Key: 205491590
• Report Number: 2024168-2020-07334
• 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: 10/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/06/2021
• Device Catalogue Number: SGC0302
• Device Lot Number: 00406U104
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 1 IMPLANTED MITRACLIP; 1 IMPLANTED MITRACLIP
• Patient Outcome(s): Required Intervention