MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MAPLE GROVE EPIC¿ VASCULAR; STENT, ILIAC

Model Number	H74939200061220
Medical Device Problem Code	Bent (1059)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/27/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Age at time of event: 18 years or older (b)(4).
Event or Problem Description
It was reported that stent damage occurred.The 100% stenosed target lesion was located in a moderately tortuous superficial femoral artery.A contralateral approach was used to gain access to the target lesion and a 6 x 120 x 120 mm epic¿ vascular stent was advanced over a steep bifurcation in the iliac artery.During advancement the catheter shaft kinked and the outer sheath was unable to be removed.The physician continued the procedure ad initiated stent deployment.During deployment the stent was observed to be shortening as it was deploying.In attempts to straighten the stent the physician stretched the stent delivery catheter shaft by applying tension; however, the stent shortening issue was not resolved and the stent was shortened as it was implanted.As a result of the shortened stent the lesion was not fully covered and additional stenting was required.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was not received for analysis.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause is operational context as device performance was limited due to anatomical/procedural factors.
Event or Problem Description
It was reported that stent damage occurred.The 100% stenosed target lesion was located in a moderately tortuous superficial femoral artery.A contralateral approach was used to gain access to the target lesion and a 6x120x120mm epic¿ vascular stent was advanced over a steep bifurcation in the iliac artery.During advancement the catheter shaft kinked and the outer sheath was unable to be removed.The physician continued the procedure ad initiated stent deployment.During deployment the stent was observed to be shortening as it was deploying.In attempts to straighten the stent the physician stretched the stent delivery catheter shaft by applying tension; however, the stent shortening issue was not resolved and the stent was shortened as it was implanted.As a result of the shortened stent the lesion was not fully covered and additional stenting was required.No patient complications were reported.

• Brand Name: EPIC¿ VASCULAR
• Common Device Name: STENT, ILIAC
• Manufacturer (Section D): BOSTON SCIENTIFIC - MAPLE GROVE; one scimed place; maple grove MN 55311
• MDR Report Key: 6582710
• Report Number: 2134265-2017-04896
• Device Sequence Number: 16309077
• Product Code: NIO
• UDI-Device Identifier: 08714729805229
• UDI-Public: (01)08714729805229(17)20180228(10)0017679520
• Combination Product (Y/N): N
• PMA/510(K) Number: P110035
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/27/2017

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: 02/28/2018
• Device Model Number: H74939200061220
• Device Catalogue Number: 39200-06122
• Device Lot Number: 0017679520
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/27/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/22/2017
• Supplement Report FDA Received Date: 05/23/2017
• 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: CRUISE 0.014
• Outcome Attributed to Adverse Event: Required Intervention