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

Catalog Number SGC0302

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/05/2020

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.

Event Description

This is being filed to report the leak requiring intervention.It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 3.One clip was successfully placed without issue.During insertion of the second clip delivery system (cds) the hemostatic valve was no longer tight and air entered the steerable guide catheter (sgc).Aspiration was performed and the sgc was replaced with a new one.The second clip was implanted, reducing mr to 1-2.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 revealed no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other complaints reported from this lot.The investigation was unable to determine a cause for the reported leak.The reported additional therapy/non-surgical treatment was a result of case-specific circumstance as aspiration was performed due to the leak.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: 10928396
• MDR Text Key: 218971290
• Report Number: 2024168-2020-10027
• 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: 01/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/03/2020
• Device Catalogue Number: SGC0302
• Device Lot Number: 91204U146
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/06/2020
• Initial Date FDA Received: 12/01/2020
• Supplement Dates Manufacturer Received: 12/21/2020
• Supplement Dates FDA Received: 01/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 1 IMPLANTED MITRACLIP; CLIP DELIVERY SYSTEM; 1 IMPLANTED MITRACLIP; CLIP DELIVERY SYSTEM
• Patient Outcome(s): Required Intervention