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.

Manufacturer Narrative

The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other complaint reported from this lot.It should be noted that per mitraclip instructions for use (ifu) states that ¿release the sleeve fastener and retract the clip delivery system (cds) approximately 10 cm into the guide by pulling only on the sleeve handle¿ should be performed before, ¿carefully retract the guide tip into the right atrium (ra).The guide may be straightened further with the +/- knob if desired¿.Based on the information provided within this complaint, the sgc was inadvertently retracted into the ra without retracting the cds into the guide.Therefore, the reported improper or incorrect procedure or method appears to be due to user error.All available information was investigated, and the reported difficult to remove is a cascading effect of failure to follow steps.The reported positioning failure and difficult to advance was due to challenging patient anatomical condition.The reported unintended movement was an outcome of procedural circumstance.The reported perforation was due to troubleshooting steps during the procedure.Perforation is listed in the mitraclip system instructions for use as a known possible complication associated with mitraclip procedures.There is no indication of product issue with respect to manufacture, design or labeling.

• Brand Name: MITRACLIP SYSTEM STEERABLE GUIDE CATHETER
• Type of Device: VALVE REPAIR
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• 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
• PMA/PMN Number: K161985
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/27/2021
• Device Catalogue Number: SGC0302
• Device Lot Number: 00726U148
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/24/2021
• Initial Date FDA Received: 07/19/2021
• Supplement Dates Manufacturer Received: 09/02/2021
• Supplement Dates FDA Received: 09/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CLIP DELIVERY SYSTEM; CLIP DELIVERY SYSTEM
• Patient Outcome(s): Other
• Patient Age: 87 YR