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

Catalog Number SGC0302

Device Problems Improper or Incorrect Procedure or Method (2017); Failure to Advance (2524); Deformation Due to Compressive Stress (2889)

Patient Problem Perforation of Vessels (2135)

Event Date 05/10/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device will not be returned for evaluation, the device was reportedly discarded.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

This is being filed to report vessel perforation requiring intervention.It was reported that this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 4.The steerable guide catheter (sgc) was advanced in the vein, however, met resistance therefore force was applied and the sgc kinked.The sgc was removed and the vein dilated, however a perforation of the vena iliaca was noted.A stent was implanted as treatment and the procedure was aborted with the mr remaining at 4.There was no adverse patient sequela.No additional information was provided.

Manufacturer Narrative

The device was not returned.A review of the lot history record identified no manufacturing nonconformities issued to the reported lots and a review of the complaint history identified no other incident reported from this lot.Based on this information a cause for the reported failure to advance issue could not be determined.Additionally, the reported kink in the shaft and perforation appear to be due to the user error of applying force when inserting sgc.It should be noted that the mitraclip ntr/xtr system instructions for use (ifu) states: do not use excessive force to advance or manipulate the guide-dilator assembly.If resistance is encountered, use echocardiography and/or fluoroscopy to assess before proceeding.Use of excessive force may result in arrhythmias, vascular and/or cardiac injury, including creation of a clinically significant atrial septal defect.The reported unexpected medical intervention was a result of case specific circumstances there is no indication of a 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: 11863255
• MDR Text Key: 251946956
• Report Number: 2024168-2021-04299
• 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: 07/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/10/2021
• Device Catalogue Number: SGC0302
• Device Lot Number: 01210U244
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention