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

Model Number	39202
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	09/26/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Age at time of event: 18 years or older.
Event or Problem Description
It was reported that stent foreshortening occurred.The 80% re-stenosed target lesion was located in a shunt in the moderately tortuous and non-calcified cephalic vein.After a 7x100x75 epic stent was implanted, it was noted that the stent foreshortened for about 6cm causing vessel obstruction.Further devices were unable to pass through.The patient was sent for surgery and graft replacement was performed.No further complications were reported.
Additional Manufacturer Narrative
Age at time of event: 18 years or older.
Event or Problem Description
It was reported that stent foreshortening occurred.The 80% re-stenosed target lesion was located in a shunt in the moderately tortuous and non-calcified cephalic vein.After a 7x100x75 epic stent was implanted, it was noted that the stent foreshortened for about 6cm causing vessel obstruction.Further devices were unable to pass through.The patient was sent for surgery and graft replacement was performed.No further complications were reported.Device was returned for analysis.The outer sheath, tip, inner sheath and the remainder of the device were checked for damage.Visual analysis showed that the inner liner had multiple kinks from the tip proximally to 13cm.It was noticed the stent was not returned with the device.The stent was implanted in the patient.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.

• 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: 7978758
• Report Number: 2134265-2018-62051
• Device Sequence Number: 1381029
• Product Code: NIO
• UDI-Device Identifier: 08714729805557
• UDI-Public: 08714729805557
• 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: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/09/2018

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: 10/08/2022
• Device Model Number: 39202
• Device Catalogue Number: 39202
• Device Lot Number: 0021232060
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2018
• Initial Date Received by Manufacturer: 09/26/2018
• Supplement Date Received by Manufacturer: 10/18/2018
• Initial Report FDA Received Date: 10/18/2018
• Supplement Report FDA Received Date: 11/09/2018
• 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: GUIDE WIRE: KYOUSHA 035X150; GUIDE WIRE: KYOUSHA 035X150; INTRODUCER SHEATH: MOSQUITO SHEATH 6F; INTRODUCER SHEATH: MOSQUITO SHEATH 6F; GUIDE WIRE: KYOUSHA 035X150; INTRODUCER SHEATH: MOSQUITO SHEATH 6F
• Outcome Attributed to Adverse Event: Required Intervention