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

Model Number	H74939200064020
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/29/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).  device evaluated by mfr: it is indicated that the device will not be returned for evaluation.If there is any further relevant information from that review, a supplemental medwatch will be filed.  (b)(4).
Event or Problem Description
It was reported that stent placement problem occurred.The 60% stenosed target lesion was located in the mildly tortuous and severely calcified superficial femoral artery.After a 014 choice pt guide wire crossed the lesion, a 6x40x120mm epic¿ stent was advanced for treatment.However, upon stent deployment, the stent jumped forward and missed the lesion.The stent was deployed at the wrong spot.The physician used another of the same device to complete the procedure.No patient complications were reported and patient's status was fine.

• Brand Name: EPIC¿ VASCULAR
• Common Device Name: STENT, ILIAC
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 7541597
• Report Number: 2134265-2018-04471
• Device Sequence Number: 2435467
• Product Code: NIO
• UDI-Device Identifier: 08714729805281
• UDI-Public: 08714729805281
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/30/2018

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: 03/22/2023
• Device Model Number: H74939200064020
• Device Catalogue Number: 39200-06402
• Device Lot Number: 0021900923
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/30/2018
• Initial Report FDA Received Date: 05/24/2018
• 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
• Patient Age: 68 YR