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

Catalog Number SGC0302

Device Problems Leak/Splash (1354); Unstable (1667)

Patient Problems Air Embolism (1697); Non specific EKG/ECG Changes (1817)

Event Date 08/07/2020

Event Type  Injury  

Manufacturer Narrative

The device has been received.Investigation has not been completed.A follow-up report will be submitted with all additional relevant information.The additional steerable guide catheter referenced is filed under separate medwatch report number.

Event Description

This is filed to report a leak, air embolism and myocardial infarction (mi).It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 4.Prior to the procedure, it was noted that patient had a small atrium.The steerable guide catheter (sgc 00308u150) was advanced to the left atrium (la).The dilator and guide wire were removed, but it was noted the st-elevation had elevated and it was confirmed that air had entered the patient.No aspiration was performed, and the procedure was continued.No hemodynamic changes were observed; therefore, the clip introducer was inserted into the hemostatic valve of the sgc, but it was noticed that the sgc lost fluid column.The clip introducer was removed and reinserted, but the water level continued to drop; therefore, the sgc was removed.It was suspected that the hemostatic valve might not have been working properly.A new sgc (00308u246) was advanced, but after inserting the clip delivery system (cds), a loss of fluid column occurred.Aspiration was performed and the cds was removed.It was noted that the loss of fluid column may have been caused by insufficient closure of the hemostatic valve.The cds was reinserted and the sgc functioned as intended.The clip was successfully implanted, reducing mr to a grade of <1.After the procedure, the physician stated that no air was noticed in the left ventricle or aorta, so it was determined that the air had disappeared.The st-elevation was unable to be returned to normal.There was no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

All available information was investigated and the reported leaks and issue with the hemostasis valve could not be confirmed via returned device 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 did not indicate a lot-specific quality issue.The investigation was unable to determine a cause for the reported leaks and issue with the hemostasis valve.The air embolism and ekg/ecg changes appear to be due to the procedural condition of the leaks.The patient effects of air embolism and ekg/ecg changes are listed in the instructions for use (ifu) as known possible complications associated with mitraclip procedures.There is no indication of a product issue with respect to manufacture, design, or labeling.Na.

• 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: 10460785
• MDR Text Key: 204581143
• Report Number: 2024168-2020-07173
• 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: 10/20/2020

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: 03/11/2021
• Device Catalogue Number: SGC0302
• Device Lot Number: 00308U150
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2020
• Initial Date Manufacturer Received: 08/07/2020
• Initial Date FDA Received: 08/27/2020
• Supplement Dates Manufacturer Received: 10/02/2020
• Supplement Dates FDA Received: 10/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CLIP DELIVERY SYSTEM; CLIP DELIVERY SYSTEM
• Patient Outcome(s): Other
• Patient Age: 61 YR
• Patient Weight: 50