MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INNOVA VASCULAR; STENT, SUPERFICIAL FEMORAL ARTERY

Model Number H74939293081530

Device Problem Entrapment of Device (1212)

Patient Problem Insufficient Information (4580)

Event Date 07/12/2022

Event Type  malfunction  

Event Description

Innova vascular otw self-expanding stent system 8mm x 150mm x 130cm was placed in left sfa and deployed but not fully expanded towards the last part.The medtronic rep recommended chocolate scoring balloon to use to open the rest of the stent.However, the balloon got stuck inside the stent resulting with prolonged fluoroscopy time to remove balloon.Doctors were consulted.In the end after several attempts able to remove chocolate balloon.

• Brand Name: INNOVA VASCULAR
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 15174078
• MDR Text Key: 297326235
• Report Number: 15174078
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/29/2022,07/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: H74939293081530
• Device Catalogue Number: H74939293081530
• Device Lot Number: 27858690
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/29/2022
• Date Report to Manufacturer: 08/05/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/05/2022
• Type of Device Usage: Unknown
• Patient Sequence Number: 1