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

Model Number	H74939200088020
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/21/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).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.(b)(4).
Event or Problem Description
It was reported the stent was the wrong size.The target lesion was located in an 85% stenosed and severely tourtous left leg iliac artery.A contralateral approach was used to access the pre-dilated lesion.A 6f non bsc sheath and a 5f non bsc guide catheter were advanced.The target lesion was then subsequently treated with an epic¿ vascular 8x80x120mm stent.During deployment the stent deployed the first 2cm normal.However, the physician found the rest of length of deployed stent was shorter than expected.The deployed stent was no more than 5 cm long and the lesion was not fully covered.The physician then selected a 8x10mm non bsc stent to cover the remainder of the lesion.The procedure was completed by post-dilating the stent with a mustang balloon catheter.The patient was stable without any complications.

• 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: 6582745
• Report Number: 2134265-2017-04837
• Device Sequence Number: 115853
• Product Code: NIO
• UDI-Device Identifier: 08714729805724
• UDI-Public: (01)08714729805724(17)20190228(10)18929557
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• PMA/510(K) Number: P110035
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• 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: 02/28/2019
• Device Model Number: H74939200088020
• Device Catalogue Number: 39200-08802
• Device Lot Number: 18929557
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/27/2017
• Initial Report FDA Received Date: 05/22/2017
• 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: GUIDE CATHETER: 5F TERUMO; SHEATH: 6F COOK
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 83 YR