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

Catalog Number SGC0302

Device Problems Break (1069); Product Quality Problem (1506)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/17/2020

Event Type  malfunction  

Manufacturer Narrative

The device is expected to be returned for evaluation. It has not yet been received. A follow up report will be submitted with all additional relevant information. The additional device referenced is being filed under a separate medwatch report.

Event Description

This is filed to report a broken hemostasis valve. 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 the patient had very friable leaflets. The clip delivery system (cds) (91205u230) was inserted into the steerable guide catheter (sgc) (00213u344), but it was noticed that the sgc was facing in a posterior direction, but the clip was positioned in the anterior direction. This caused the sgc to be move in an abnormal direction. Therefore, the cds was attempted to be removed, but during removal the clip became stuck on the hemostasis valve of the sgc. It was then noticed that the hemostasis valve was broken; therefore, the sgc was removed from the stabilizer and placed below the heart to prevent the insertion of air. The physician was then able to remove both the cds and sgc without further issues. It was noted that the difficulty removing the clip was caused by the cds. A new sgc was inserted and one clip was successfully implanted on the lateral side of a2p2. To further reduce mr, an additional clip (91105u165) was implanted medially of the first clip. A remaining jet was noticed; therefore, a third clip was inserted and implanted at a3p3. However, after the third clip was implanted, it was noticed that the second clip caused a tear on the posterior leaflet. No additional clips were implanted mr reduced to a grade of 2-3. 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: 10385901
• MDR Text Key: 202795461
• Report Number: 2024168-2020-06647
• 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

0 Patients were Involved in the Event:

• Date FDA Received: 08/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 02/11/2021
• Device Catalogue Number: SGC0302
• Device Lot Number: 00213U344
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2020
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 09/24/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/12/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial