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

Catalog Number SGC0302

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

Patient Problem Thrombosis (2100)

Event Date 06/22/2020

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.

Event Description

This is being filed to report the thrombosis. 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 inserted into the patient and then the clip delivery system (cds) was advanced. As soon as the clip exited the sgc, thrombus was noted attached to the sgc. The cds and sgc were carefully removed with the thrombus attached to the sgc. The procedure was aborted with the mr remaining at 4+. There was no clinically significant delay in the procedure and no adverse patient sequela.

• 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: 10235540
• MDR Text Key: 197755461
• Report Number: 2024168-2020-05489
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K161985
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 08/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 12/18/2020
• Device Catalogue Number: SGC0302
• Device Lot Number: 91218U210
• 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: 07/23/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/19/2019
• 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: 07/06/2020 Patient Sequence Number: 1