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

Model Number	39200
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/13/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that stent foreshortening occurred.The 99% stenosed target lesion was located in the severely tortuous and severely calcified iliac.After crossing the lesion with a 0.035 guidewire, pre-dilatation was performed.Subsequently, a 10x40x75 epic stent self expanding was used for treatment.However, shortening occurred unexpectedly, and lesion could not be covered.Another of the same device was used to complete the procedure.There were no patient injury reported.
Event or Problem Description
It was reported that stent foreshortening occurred.The 99% stenosed target lesion was located in the severely tortuous and severely calcified iliac.After crossing the lesion with a 0.035 guidewire, pre-dilatation was performed.Subsequently, a 10x40x75 epic stent self expanding was used for treatment.However, shortening occurred unexpectedly, and lesion could not be covered.Another of the same device was used to complete the procedure.There were no patient injury reported.It was further reported that the size of the stent was confirmed prior to the procedure and foreshortening determined when the cell spacing of the stent became narrower during the time of stent deployment.The stent was completely deployed and the physician used an eluvia stent to cover the remaining lesion.

• 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: 11237127
• Report Number: 2134265-2021-00811
• Device Sequence Number: 3842929
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/04/2021

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 Expiration Date: 10/06/2025
• Device Model Number: 39200
• Device Catalogue Number: 39200
• Device Lot Number: 0026147220
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/18/2021
• Supplement Date Received by Manufacturer: 01/28/2021
• Initial Report FDA Received Date: 01/27/2021
• Supplement Report FDA Received Date: 02/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention