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

Model Number 26921

Device Problem Fracture (1260)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/16/2023

Event Type  Injury  

Event Description

It was reported that the stent fractured.An 8 x 60 x 75 innova self-expanding stent was selected for use in a percutaneous transhepatic biliary stent implantation in the stenosed right bile duct.When the stent was deployed, it was noted that the stent might have been fractured.Post-dilation was attempted with a balloon but failed.A non-boston scientific drainage catheter was placed into the left bile duct, and the procedure was completed with another innova self-expanding stent.There were no patient complications reported, and the patient was in stable condition following the procedure.

Manufacturer Narrative

Media analysis by manufacturer: the device was not returned for analysis; however, media was provided in the form of three photos and one video.The media provided clearly shows the stent, and it does appear to be fractured.

Event Description

It was reported that the stent fractured.An 8 x 60 x 75 innova self-expanding stent was selected for use in a percutaneous transhepatic biliary stent implantation in the stenosed right bile duct.When the stent was deployed, it was noted that the stent might have been fractured.Post-dilation was attempted with a balloon but failed.A non-boston scientific drainage catheter was placed into the left bile duct, and the procedure was completed with another innova self-expanding stent.There were no patient complications reported, and the patient was in stable condition following the procedure.It was further reported that the bile duct was 90% stenosed with severe biliary tortuosity.The procedure was completed without another innova self-expanding stent; only one drainage catheter was placed to end the procedure.The drainage catheter was not originally planned.

• Brand Name: INNOVA
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 16897177
• MDR Text Key: 314849308
• Report Number: 2124215-2023-22669
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 26921
• Device Catalogue Number: 26921
• Device Lot Number: 0031002416
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/07/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 52 YR
• Patient Sex: Female
• Patient Weight: 50 KG