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

Model Number SGC0301

Device Problems Difficult to Remove (1528); Physical Resistance/Sticking (4012)

Patient Problem Atrial Perforation (2511)

Event Date 11/04/2020

Event Type  Injury  

Manufacturer Narrative

The customer reported the device is not returning. Investigation is not yet complete. A follow up report will be submitted with all additional relevant information. The additional mitraclip delivery system referenced is filed under a separate medwatch report number.

Event Description

This is filed to report atrial perforation, tissue damage, difficult to remove. It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 4. The steerable guide catheter (sgc) was advanced to the mitral valve, and the first clip was deployed, reducing mr. Then a second clip delivery system (cds) was advanced to the mitral valve; however, the septum tore causing the sgc to lose height. Then the cds dropped below the valve, and the clip became entangled with the chordae. After maneuvering, the clip became freed, but a chordal rupture occurred. A decision was made to remove the sgc and cds from the patient to abort the procedure. After the cds was removed, it was noted that the actuator mandrel was protruding distally. Additional treatment was not performed. The patient is stable. One clip was implanted, reducing mr to 3. There was no clinically significant delay in the procedure. 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
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005070406; 3885 bohannon drive; menlo park CA 94025
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 10900244
• MDR Text Key: 218242038
• Report Number: 2024168-2020-09898
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161985
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 01/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 06/12/2021
• Device Model Number: SGC0301
• Device Catalogue Number: SGC0301
• Device Lot Number: 00612U112
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 12/14/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/12/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 11/25/2020 Patient Sequence Number: 1

Treatment

1 IMPLANTED MITRACLIP; CLIP DELIVERY SYSTEM