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

Model Number	39200
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/06/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that stent profile issue occurred.The 90% stenosed target lesion was located in the moderately tortuous and mildly calcified iliac artery.A 10x60x75mm epic stent was implanted for treatment.However, during post-dilation with a 8x60mm sterling balloon catheter, it was noted that the stent was 1-2cm longer than the 60mm balloon.The physician suspects the stent length elongated.No patient complications were reported.
Event or Problem Description
It was reported that stent profile issue occurred.The 90% stenosed target lesion was located in the moderately tortuous and mildly calcified iliac artery.A 10x60x75mm epic stent was implanted for treatment.However, during post-dilation with a 8x60mm sterling balloon catheter, it was noted that the stent was 1-2cm longer than the 60mm balloon.The physician suspects the stent length elongated.No patient complications were reported.
Additional Manufacturer Narrative
E1: initial reporter city - (b)(6).Device evaluated by mfr.: a media from the clinical procedure was received and reviewed.The media review report concluded that there were no device or stent malfunctions observed.Patient anatomy looked to be patent with good blood flow.

• Brand Name: EPIC VASCULAR
• Common Device Name: STENT, ILIAC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 9752305
• Report Number: 2134265-2020-01997
• Device Sequence Number: 2205086
• Product Code: NIO
• UDI-Device Identifier: 08714729805052
• UDI-Public: 08714729805052
• 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: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/18/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/12/2024
• Device Model Number: 39200
• Device Catalogue Number: 39200
• Device Lot Number: 0023790600
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/06/2020
• Supplement Date Received by Manufacturer: 03/05/2020
• Initial Report FDA Received Date: 02/25/2020
• Supplement Report FDA Received Date: 03/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GUIDEWIRE: JUPITER FC; GUIDEWIRE: JUPITER FC