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

Catalog Number SGC0302

Device Problem Failure to Advance (2524)

Patient Problems Perforation (2001); No Consequences Or Impact To Patient (2199)

Event Date 07/21/2020

Event Type  Injury  

Manufacturer Narrative

The customer reported the device was discarded.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.

Event Description

This is filed to report the perforation.It was reported this was a mitraclip procedure to treat grade 4 mixed mitral regurgitation (mr) and a triclip procedure to treat grade 4+ tricuspid regurgitation (tr).When advancing the steerable guide catheter (sgc) over the guide wire, high resistance was felt due to the tortuous vein.Fluoroscopy showed the iliac vein was perforated.The sgc was removed and manual compression was performed until the vascular surgeon arrived to do a complete evaluation.A non-abbott stent graft was implanted and was post-dilated with a 12x40mm peripheral balloon, successfully controlling the leakage.The patient remained stable during the process.Treatment of mitral and tricuspid valve was continued, through the left femoral vein.Two mitraclips were implanted in the mitral valve, reducing mr to 1-2.One triclip was implanted in the tricuspid valve, reducing tr to 2+.No additional information was provided.

Manufacturer Narrative

The device was not returned for analysis.A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot that would have contributed to the event.Additionally, a review of the complaint history identified no similar incidents reported from this lot.Based on the information reviewed, the reported failure to advance-septum was due to challenging patient anatomy.There is no indication of a product issue with respect to manufacture, design, or labeling.Although the steerable guide catheter (sgc) did not cause the perforation, this event has been reported; therefore, it will remain reportable.B5: describe event or problem although the steerable guide catheter (sgc) did not cause the perforation, this event has been reported; therefore, it will remain reportable.H6: patient code: 2001 - removed.

Event Description

Subsequent to the previously filed report, the following information was received: per the physician¿s opinion, the guide wire kinked due to the vessel tortuosity and the kinked guide wire caused the perforation.The mitraclip devices did not cause or worsen the perforation.Although the steerable guide catheter (sgc) did not cause the perforation, this event has been reported; therefore, it will remain reportable.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
• MDR Report Key: 10383071
• MDR Text Key: 202178141
• Report Number: 2024168-2020-06631
• 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: 09/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/27/2021
• Device Catalogue Number: SGC0302
• Device Lot Number: 00327U104
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention