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

Catalog Number SGC0302

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fistula (1862); Hemorrhage/Bleeding (1888)

Event Date 09/29/2020

Event Type  Injury  

Manufacturer Narrative

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 filed to report a hemorrhage and fistula.It was reported that this was a mitraclip procedure to treat mixed mitral regurgitation (mr) with a grade of 3.The steerable guide catheter (sgc) was inserted, but during insertion, a spurting hemorrhage was observed.A fistula was then noticed between the femoral artery and the femoral vein.For safety reasons, the physician decided to discontinue the procedure.To treat the hemorrhage, protamine was administered, a pressure bandage was used, and the wound was stitched up.The physician stated that the injuries were suspected to be caused by the puncture of the femoral vein.However, the hemorrhage was worsened by the sgc.No clips were implanted, and mr remained at a grade of 3.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 revealed no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Based on the information available, a definitive cause for the reported patient effect of fistula and hemorrhage could not be determined.The patient effects of fistula and hemorrhage, as listed in the mitraclip system instructions for use, are known possible complications associated with mitraclip procedures.Although a conclusive cause for the reported patient effects and the relationship to the device, if any, cannot be determined, there is no indication of a product issue with respect to manufacture, design or labeling.Na.

• 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: 10721104
• MDR Text Key: 212713098
• Report Number: 2024168-2020-08848
• 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: 12/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/25/2021
• Device Catalogue Number: SGC0302
• Device Lot Number: 00724U215
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention