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 Problems Embolism (1829); Thrombosis (2100)

Event Date 08/31/2020

Event Type  Injury  

Manufacturer Narrative

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 thrombus.It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with grade 4.At the beginning of the procedure, when inserting steerable guide catheter (sgc) thrombus was noted on the right atrial lead of the pacemaker.The procedure proceeded and during insertion, the thrombus was carried to the left atrium.A snare device tried to snare the thrombus and with a separate catheter, aspiration was performed.However, the thrombus had embolized.Neurology was consulted and the procedure continued.Two clips were implanted, reducing mr to 1.The procedure was finished with good results.After the procedure, the patient was woken up and followed all commands.There was no evidence of neurological defect.The patient was discharged.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 information available, a definitive cause for the reported patient effects could not be determined.The patient effects of thrombosis and embolism are listed in the mitraclip instructions for use as known possible complications associated with mitraclip procedures.Additional therapy / non-surgical treatment was a result of case-specific circumstances as snaring was done due to the thrombus.Treatment with medication was a result of case-specific circumstances as heparin was given at the start of the procedure.Although a conclusive cause for the reported patient effects and the relationship to the device, if any, cannot be determined, there is no indication of a product issue with respect to manufacture, design or labeling.

Event Description

Additional information received reported that heparin was the only anticoagulant administered and the thrombus resolved on its own.No additional information was provided.

• 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: 10570254
• MDR Text Key: 208084920
• Report Number: 2024168-2020-07915
• 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: 11/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/23/2021
• Device Model Number: SGC0301
• Device Catalogue Number: SGC0301
• Device Lot Number: 00622U233
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 81 YR
• Patient Weight: 87