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

Model Number	39200
Medical Device Problem Codes	Break (1069); Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/02/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that shaft break and stent deployment issue occurred.The target lesion was located in the mildly tortuous and moderately calcified left iliac artery.Two 10x80x75 epic stents were used for treatment.However, during the procedure on both devices, the shaft came apart from the stent before fully deployment.Additional stent was deployed to make sure original stents stayed deployed and fully opened.There were no patient complications nor injuries reported.
Additional Manufacturer Narrative
B5.Describe event or problem- corrected and updated.Device evaluated by mfr.: returned product consisted of an epic self-expanding stent system.The outer sheath, tip, inner sheath and the remainder of the device were checked for damage.Visual examination revealed multiple kinks along the inner liner.The inner liner is separated from the handle.Microscopic examination revealed no additional damages.Inspection of the remainder of the device presented no other damage or irregularities.
Event or Problem Description
It was reported that stent detachment occurred.The target lesion was located in the mildly tortuous and moderately calcified left iliac.Two 10x80x75 epic stent was advanced for treatment.However, during procedure on both devices, the shaft came apart from the stent before fully deployment.Additional stent was deployed to make sure original stents stayed deployed and fully opened.There were no patient complications nor injuries reported.It was further reported that just one 10x80x75 epic stent was used and not two epic stents as previously reported.There was resistance during advancing of the device and the shaft break occurred prior to stent deployment.

• Brand Name: EPIC VASCULAR
• Common Device Name: STENT, ILIAC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 12814640
• Report Number: 2134265-2021-14114
• Device Sequence Number: 11951246
• Product Code: NIO
• UDI-Device Identifier: 08714729805090
• UDI-Public: 08714729805090
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/29/2021

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: 07/06/2026
• Device Model Number: 39200
• Device Catalogue Number: 39200
• Device Lot Number: 0027623460
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/02/2021
• Supplement Date Received by Manufacturer: 11/11/2021
• Initial Report FDA Received Date: 11/15/2021
• Supplement Report FDA Received Date: 11/29/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/07/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown