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

Model Number SGC0301

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

Patient Problem Thrombosis (2100)

Event Date 08/10/2020

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.The clip delivery system referenced is filed under a separate medwatch report number.

Event Description

This is being filed to report the thrombus requiring intervention.It was reported that this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 3+.The steerable guide catheter (sgc) was advanced into the patient when thrombus was noted on the guide wire.The dilator was pulled back into the sgc and aspiration performed.The sgc and dilator were removed from the anatomy once the thrombus was aspirated.The sgc and dilator were flushed and prepped again.The sgc was then re-inserted into the anatomy however thrombus was again noted on the wire.The sgc and dilator were removed and aspiration performed.The guide wire was exchanged and the sgc was advance again with no issue.One clip was implanted on the mitral valve, reducing mr to 1+.The tricuspid valve was the attempted to be treated.The clip delivery system (cds) was steered down however there was not enough height to pull the clip up therefore the cds was under-straddled to complete grasping the septal / posterior leaflets.The gripper line was removed prior to clip deployment to reduce the stress on the leaflets.When the actuator knob was pulled back, the clip did not release from the delivery catheter (dc).After careful sgc manipulation, the cds was retracted further into the sgc and the clip was able to separate.The clip was stable on the leaflets and the tr reduced from 4 to 1-2.There was no clinically significant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 did not identify any manufacturing nonconformities issued to the reported lot.Based on the information reviewed, a cause for the reported thrombosis could not be determined.The reported patient effect of thrombus as listed in the mitraclip 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: 10465241
• MDR Text Key: 204868202
• Report Number: 2024168-2020-07200
• 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,health
• Type of Report: Initial,Followup
• Report Date: 09/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/10/2021
• Device Model Number: SGC0301
• Device Catalogue Number: SGC0301
• Device Lot Number: 00609U131
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 85 YR
• Patient Weight: 49