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

Model Number H74939200084070

Device Problem Bent (1059)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/24/2018

Event Type  malfunction  

Manufacturer Narrative

Age at time of event: 18 years or older.(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 obtained, a supplemental mdr will be filed.(b)(4).

Event Description

It was reported that stent damage occurred.The 99% stenosed target lesion was located in the severely tortuous and severely calcified external iliac artery.After a guide wire crossed the lesion and pre-dilatation was performed, an 8x40x75 epic¿ vascular stent was advanced for treatment.However, the distal tip got caught in the calcification and it failed to cross the lesion.The device was completely removed and it was noted that the distal tip of the stent struts were slightly lifted.The procedure was completed with a different device.No patient complications were reported and the patient¿s status was stable.

• Brand Name: EPIC¿ VASCULAR
• Type of Device: STENT, ILIAC
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• Manufacturer (Section G): BOSTON SCIENTIFIC - GALWAY
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 7592738
• MDR Text Key: 110801240
• Report Number: 2134265-2018-05319
• Device Sequence Number: 1
• Product Code: NIO
• UDI-Device Identifier: 08714729805656
• UDI-Public: 08714729805656
• Combination Product (y/n): N
• PMA/PMN Number: P110035
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/14/2022
• Device Model Number: H74939200084070
• Device Catalogue Number: 39200-08407
• Device Lot Number: 21518627
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/24/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/15/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1