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

Model Number 39200

Device Problem Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/17/2020

Event Type  Injury  

Manufacturer Narrative

(b)(6).

Event Description

It was reported that stent foreshortening occurred.The 75% stenosed target lesion was located in a moderately tortuous and moderately calcified iliac artery.A 10x40x75 epic (epic vascular) stent was selected for use.During deployment, the physician intended to apply tension properly during deployment; however, the device was eventually shortened.Subsequently, an additional stent was placed and the procedure was completed with a different device.No patient complications nor injuries reported.

• Brand Name: EPIC VASCULAR
• Type of Device: STENT, ILIAC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 10184103
• MDR Text Key: 196084419
• Report Number: 2134265-2020-08346
• Device Sequence Number: 1
• Product Code: NIO
• UDI-Device Identifier: 08714729805014
• UDI-Public: 08714729805014
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 06/23/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 05/21/2024
• Device Model Number: 39200
• Device Catalogue Number: 39200
• Device Lot Number: 0023843038
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/17/2020
• Initial Date FDA Received: 06/23/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/23/2019
• 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
• Patient Outcome(s): Other