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

Model Number	39200
Medical Device Problem Codes	Device-Device Incompatibility (2919); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/14/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that stent damage post-deployment occurred.Vascular access was obtained utilizing an ipsilateral retrograde puncture.The 90% stenosed target lesion was located in the moderately tortuous and mildly calcified right common iliac artery.The lesion length was slightly less than 4cm.After a 235cm jupiter sfc guidewire and a 6f non-boston scientific guide catheter were advanced, pre-dilatation was performed with an 8.0x20 sterling mr balloon catheter.Subsequently, a 10x40x75 epic vascular stent was deployed and post dilatation was performed using a 10.0x40 non-boston scientific balloon.Intravenous ultrasound confirmed the stent was properly apposed to the vessel wall.However, when the non-bsc guide catheter was moved up for final imaging, the stent got caught causing the distal edge to lift and shorten.Balloon dilatation was then attempted with the 8.0x20 sterling mr balloon catheter, however sufficient dilatation could not be obtained.A 10.0x40 non-bsc balloon was attempted to be used but it could not be inserted inside the stent.A 4.0x40 non-bsc balloon was also used but sufficient dilatation still could not be obtained.Since good blood flow was observed, no further intervention was performed and the procedure was completed.There were no patient complications and the patient condition was stable.It was further reported that 8.0x20 sterling mr balloon catheter was able to inflate but failed to dilate the lesion.There was no problem with the stent size after placement.The area where the shortening occurred was visually reduced to approximately 50% of the size.

• Brand Name: EPIC VASCULAR
• Common Device Name: 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: 16918435
• Report Number: 2124215-2023-19868
• Device Sequence Number: 20565457
• Product Code: NIO
• UDI-Device Identifier: 08714729805014
• UDI-Public: 08714729805014
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P110035
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/12/2023

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
• Operator of Device: Health Professional
• Device Model Number: 39200
• Device Catalogue Number: 39200
• Device Lot Number: 0030630904
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/17/2023
• Initial Report FDA Received Date: 05/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BALLOON CATHETER: STERLING MR 8.0-20; GUIDE CATHETER: MEDIKIT PARENT 6FR; GUIDEWIRE: JUPITER SFC 235CM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown