MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EPIC VASCULAR; STENT, ILIAC

Model Number 39201

Device Problems Device-Device Incompatibility (2919); Material Deformation (2976)

Patient Problem Restenosis (4576)

Event Date 04/18/2023

Event Type  Injury  

Event Description

It was reported that in-stent restenosis and stent damage occurred.Several years ago, a 2mmx6cm epic stent was implanted in the left subclavian vein.In (b)(6) 2023, the implanted stent had 95% in-stent restenosed and was moderately tortuous and mildly calcified.A 12.0 x 40, 75cm mustang balloon catheter was advanced to dilate the lesion along with a non-boston scientific guidewire.However, it was observed that the tip of the mustang caught on the edge of the stent, causing the edge of the stent to flip.The balloon catheter was removed and a different device was used to complete the procedure.There were no patient complications nor injuries reported.

Event Description

It was reported that in-stent restenosis and stent damage occurred.Several years ago, a 2mmx6cm epic stent was implanted in the left subclavian vein.In (b)(6) 2023, the implanted stent had 95% in-stent restenosed and was moderately tortuous and mildly calcified.A 12.0 x 40, 75cm mustang balloon catheter was advanced to dilate the lesion along with a non-boston scientific guidewire.However, it was observed that the tip of the mustang caught on the edge of the stent, causing the edge of the stent to flip.The balloon catheter was removed, and a different device was used to complete the procedure.There were no patient complications nor injuries reported.It was further reported that the epic vascular stent size is 6x120x75 and not 2mmx6cm as previously reported.

Manufacturer Narrative

B5.Describe event or problem corrected from 2mm to 12mm.D1.Brand name from epic biliary to epic vascular.D2a.Common device name from catheter, biliary, diagnostic to stent, iliac.D2b.Pro code from fge to nio.D4.Model and catalog number updated.

• Brand Name: EPIC VASCULAR
• Type of Device: STENT, ILIAC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 16949754
• MDR Text Key: 315421798
• Report Number: 2124215-2023-22530
• Device Sequence Number: 1
• Product Code: NIO
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P110035
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 39201
• Device Catalogue Number: 39201
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/19/2023
• Initial Date FDA Received: 05/17/2023
• Supplement Dates Manufacturer Received: 05/22/2023
• Supplement Dates FDA Received: 06/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: BALLOON CATHETER: MUSTANG; BALLOON CATHETER: MUSTANG; GUIDEWIRE: SURF35; GUIDEWIRE: SURF35; INTRODUCER SHEATH: MOSQUITO 7FR; INTRODUCER SHEATH: MOSQUITO 7FR
• Patient Outcome(s): Required Intervention