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 Problems Thrombosis (2100); Atrial Perforation (2511)

Event Date 07/20/2020

Event Type  Injury  

Manufacturer Narrative

The device is not returning for analysis. A follow-up report will be submitted with all additional relevant information.

Event Description

This is filed to report the suspected thrombus. It was reported this was a mitraclip procedure to treat grade 4 functional mitral regurgitation (mr). The left atrium is enlarged, the fossa ovalis is large, and floppy. A slight patency of patent foramen ovale (pfo) was pre-existing. The steerable guide catheter (sgc) was inserted. A 5cm filamentous tissue was noted, connected from around the fossa ovalis. It is suspected the filamentous tissue is a blood clot, but it is unclear. The filamentous tissue disappeared during the procedure; the physician speculated that it may have been dissolved by a thrombus. The activated clotting time (act) was maintained for more than 250 seconds with heparin, which is the usual procedure range. The procedure was continued. Two clips were implanted, reducing mr to 1+. When removing the sgc into the right atrium, a strong left to right shunt was observed. Per the physician, the left to right shunt occurred in the sgc passage portion of the mitraclip device and was caused by the sgc. The atrial septal defect was of normal size and caused no symptoms; thus, no treatment was performed. 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: 10382337
• MDR Text Key: 202167926
• Report Number: 2024168-2020-06621
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 10/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 09/26/2020
• Device Catalogue Number: SGC0302
• Device Lot Number: 90926U237
• 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: 09/15/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/27/2019
• 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: 08/07/2020 Patient Sequence Number: 1