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

Model Number SGC0301

Device Problems Off-Label Use (1494); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Thrombosis (2100)

Event Date 02/04/2020

Event Type  Injury  

Manufacturer Narrative

The other additional device referenced is being filed under a separate medwatch report number.The customer reported the device was 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 thrombosis requiring intervention.It was reported that this was a mitraclip procedure to treat mitral regurgitation (mr) with a grade of 4+.One clip was implanted, reducing mr to 1+.The tricuspid regurgitation (tr) with a grade of 4+ was treated next.Imaging was difficult however the clip delivery system (cds) was advanced and placed on the tricuspid valve.During deployment, the clip was misaligned and the grippers only attached to the septal leaflet.During removal of the cds, the steerable guide catheter (sgc) was occluded by a clot.The sgc was removed and cleaned outside the patient.The sgc was then readvanced into the patient with no issue.A second cds was advanced and the clip was implanted to stabilize the first clip, reducing tr to 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.The investigation determined the thrombosis was due to procedural condition.The mitraclip instructions for use (ifu) states that the reported patient effect of thrombosis is a known possible complication associated with mitraclip procedures.It should be noted that the mitraclip ifu states: the mitraclip system is a device indicated for the percutaneous reduction of significant symptomatic mitral regurgitation.In this case, the device was used for a tricuspid valve procedure; however, it was undermined if the off-label used have contribute to the reported issues.There is no indication of a product issue with respect to manufacture, design or labeling.

• Brand Name: STEERABLE GUIDE CATHETER
• Type of Device: VALVE REPAIR
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9717161
• MDR Text Key: 180728190
• Report Number: 2024168-2020-01527
• Device Sequence Number: 1
• Product Code: DRA
• UDI-Device Identifier: 08717648216824
• UDI-Public: 08717648216824
• 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: 03/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/23/2020
• Device Model Number: SGC0301
• Device Catalogue Number: SGC0301
• Device Lot Number: 90523U145
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 1 IMPLANTED MITRACLIP; CLIP DELIVERY SYSTEM
• Patient Outcome(s): Required Intervention
• Patient Age: 79 YR