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

Model Number H74939200091070

Device Problems Bent (1059); Migration or Expulsion of Device (1395)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/08/2018

Event Type  Injury  

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 medwatch will be filed.(b)(4).

Event Description

It was reported that stent damage and migration occurred.The 75% stenosed target lesion was located in the mildly tortuous and severely calcified iliac artery.After pre-dilation, a 9x100x75mm epic¿ vascular stent was implanted for treatment.However, when physician tried to advance the sheath further while using dilator, it was noted that the edge of the stent was caught in the gap and got flattened.Upon pushing further, the stent shifted.The procedure was completed by implanting another stent inside the epic stent.No patient complications nor injuries were reported.The flow until the distal was also good.

• 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: 7647823
• MDR Text Key: 112659394
• Report Number: 2134265-2018-05825
• Device Sequence Number: 1
• Product Code: NIO
• UDI-Device Identifier: 08714729805892
• UDI-Public: 08714729805892
• 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: 06/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/02/2021
• Device Model Number: H74939200091070
• Device Catalogue Number: 39200-09107
• Device Lot Number: 0018992679
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/08/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/07/2016
• 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): Required Intervention