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

Catalog Number SGC0302

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Insufficient Information (4580)

Event Date 03/03/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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 filed to report use after expiration.It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 4.An expired steerable guide catheter (sgc) was advanced to the mitral valve, and three clips were deployed.Three clips were implanted, reducing mr to 1.There were no reported adverse patient effects and no reported clinically significant delay in the procedure.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 this event.Additionally, a review of the complaint history did not indicate a lot-specific quality issue.The investigation determined the reported use after expiration was due to the user error of using an expired steerable guide catheter (sgc) for the procedure.It should be noted that, per the intended use section of the instructions for use states: ¿do not use the mitraclip system after the ¿use by¿ date stated on the package label, and never reuse or re-sterilize the system.Use of expired, reused, or re-sterilized devices may result in infection, endocarditis, and / or sepsis¿.In this case, the device was used post expiration date, which is a deviation from instruction for use (ifu).There is no indication of a product issue with respect to manufacture, design or labeling.Na.

• 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: 11562810
• MDR Text Key: 243923862
• Report Number: 2024168-2021-02340
• 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: 05/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/16/2021
• Device Catalogue Number: SGC0302
• Device Lot Number: 00217U110
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 3 IMPLANTED MITRACLIPS