MAUDE Adverse Event Report: ABBOTT VASCULAR SGC03 VALVE REPAIR

Catalog Number SGC0302

Device Problems Improper or Incorrect Procedure or Method (2017); Material Split, Cut or Torn (4008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/29/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4). The device was received. The investigation is not yet complete. A follow-up report will be submitted with all additional relevant information.

Event Description

Revised. It was reported that the mitraclip procedure was performed to treat mixed mitral regurgitation with grade of 4. The patient had a small anatomy with small atrium, the septal puncture was a huge problem and the height over the valve was 3. 3 cm. The steerable guide catheter (sgc) was inserted and advanced into artery, per the instruction for use (ifu). The physician had to manipulate the clip delivery system (cds) to gain height to the mitral valve; therefore, more curves were applied to the cds than usual and tension was very high. Before clip deployment, the gripper line broke as due to too much tension. The procedure was aborted as the second cds would have the same issue. The cds with the clip attached and gripper line were removed. There were no clips implanted, mr remained at 4. There was no adverse patient effect and no clinically significant delay in the procedure. The cds was returned inside the sgc and analysis revealed that the sgc soft tip was torn. No additional information was provided.

• Brand Name: SGC03
• 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: 9823793
• MDR Text Key: 183125977
• Report Number: 2024168-2020-02314
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 04/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 11/14/2019
• Device Catalogue Number: SGC0302
• Device Lot Number: 81114U124
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2020
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 03/27/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/14/2018
• 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: 03/12/2020 Patient Sequence Number: 1

Treatment

CLIP DELIVERY SYSTEM