MAUDE Adverse Event Report: ABBOTT VASCULAR SGC03; VALVE REPAIR

Model Number SGC0301

Device Problem Leak/Splash (1354)

Patient Problems Air Embolism (1697); Bradycardia (1751)

Event Date 03/17/2020

Event Type  Injury  

Manufacturer Narrative

The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.Na.

Event Description

This is filed to report a leak and air embolism.It was reported that this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 4.The steerable guide catheter (sgc) 91221u160 was inserted, but air started to appear in the column.Aspiration was performed, but the air was still present.It was noted that some air may have entered the patient, causing bradycardia.To treat the bradycardia, medication was given, which returned the patient heart rate to a normal sinus rhythm.The sgc was removed and was attempted to be re-prepped; however, a loss of fluid column occurred.The device was not used and was replaced.One clip was successfully implanted, reducing mr to a grade of 2.There was no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

The device was not returned.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot.Additionally, a review of the complaint history identified no similar incidents reported from this lot.All available information was investigated and a definitive cause for the reported leak could not be determined.The reported patient effects of air embolism and bradycardia appear to be related to the leak.The reported patient effects of air embolism and bradycardia as listed in the eifu, mitraclip ntr/xtr, are 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: SGC03
• Type of Device: VALVE REPAIR
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9920945
• MDR Text Key: 186717860
• Report Number: 2024168-2020-03331
• 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: 04/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/20/2020
• Device Model Number: SGC0301
• Device Catalogue Number: SGC0301
• Device Lot Number: 91121U160
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention