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

Catalog Number SGC0302

Device Problems Positioning Failure (1158); Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017); Difficult to Advance (2920); Unintended Movement (3026)

Patient Problem Perforation (2001)

Event Date 06/24/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4). 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 filed under a separate medwatch report number.

Event Description

This is filed to report atrial perforation difficult to remove. It was reported this was a mitaclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 4. It was noted there was a very tortuous venous access. The steerable guide catheter (sgc) was inserted and advanced into the left atrium (la). It was noted that due to the tortuous venous access, the sgc was difficult to advance and became kinked. Therefore, the sgc was removed and replaced. The new sgc was inserted and advanced into the la. It was noted that transseptal access was difficult. An xtw clip was inserted into the la, but at this time it was observed when rotating the guide handle, the tip of the guide did not move. It was noted that a generation 3 sgc was used with a generation 4 clip delivery system (cds). Due to the inability to steer the sgc, the physician decided to pull the clip back into the sgc and remove the devices. However, the sgc was unintentionally retracted into the right atrium (ra) and the clip remained in the la. This caused difficulty retracting the cds into the sgc. By using force, the physician was able to pull the clip through the transeptal puncture. Once in the ra, the clip was able to be retracted into the sgc and both devices were removed. Once removed, it was observed a left to right shunt was present. No additional devices were inserted, and the procedure was discontinued. Mr remained at a grade of 4. 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: 12189222
• MDR Text Key: 262217290
• Report Number: 2024168-2021-06174
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: DA
• 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: 09/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 07/27/2021
• Device Catalogue Number: SGC0302
• Device Lot Number: 00726U148
• 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: 09/02/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/27/2020
• 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: 07/19/2021 Patient Sequence Number: 1

Treatment

CLIP DELIVERY SYSTEM