MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EXPRESS SD RENAL/BILIARY; STENT, RENAL

Model Number 20188

Device Problems Unstable (1667); Deformation Due to Compressive Stress (2889)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/21/2019

Event Type  malfunction  

Event Description

Stent was inserted into the left renal artery and came off of the balloon between the left renal artery and aorta.Stent was retrieved with a snare.Due to inability to fully retract stent into the snare and guide, the stent, snare, guide and sheath were all removed simultaneously from the right femoral artery.The 4.0x15 80cm sterling monorail balloon while going into patient body was kinked and was removed and not used.New balloon was opened.

• Brand Name: EXPRESS SD RENAL/BILIARY
• Type of Device: STENT, RENAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 8939315
• MDR Text Key: 155809611
• Report Number: 8939315
• Device Sequence Number: 1
• Product Code: NIN
• 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: 08/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 20188
• Device Catalogue Number: H74937912618150
• Device Lot Number: 22631407
• 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: 08/21/2019
• Event Location: Hospital
• Date Report to Manufacturer: 08/28/2019
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 31025 DA