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

Model Number H74939200124020

Device Problems Device Damaged Prior to Use (2284); Activation, Positioning or Separation Problem (2906)

Patient Problem No Patient Involvement (2645)

Event Date 12/05/2014

Event Type  malfunction  

Event Description

It was reported that premature stent deployment occurred.A 12x40x120 epic¿ vascular stent was selected.During preparation, the physician went to insert the device into a sheath; however, it was noted that the stent had been out.The safety lock was not removed and the thumbwheel was not operated.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was good.

Manufacturer Narrative

Age at time of event: 18 years or older.(b)(4).

Manufacturer Narrative

Device evaluated by mfr: returned product consisted of an epic stent delivery system (sds).There was blood in the wire lumen and on the handle.There was no damage or irregularities of the rack length.The distal end of the stent was partially expanded a length of 6mm.The safety-lock was securely attached to the rack, as-received; however, it could not be determined if it was removed and replaced prior to return to bsc.Inspection of the remainder of the device presented no other damage or irregularities.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 Description

It was reported that premature stent deployment occurred.A 12x40x120 epic vascular stent was selected.During preparation, the physician went to insert the device into a sheath; however, it was noted that the stent had been out.The safety lock was not removed and the thumbwheel was not operated.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was good.

• Brand Name: EPIC? VASCULAR
• Type of Device: STENT, ILIAC
• Manufacturer (Section D): BOSTON SCIENTIFIC - MAPLE GROVE; one scimed place; maple grove MN 55311
• Manufacturer Contact: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 4358076
• MDR Text Key: 5232697
• Report Number: 2134265-2014-08035
• Device Sequence Number: 1
• Product Code: NIO
• Combination Product (y/n): N
• PMA/PMN Number: P110035
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/08/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/24/2016
• Device Model Number: H74939200124020
• Device Catalogue Number: 39200-12402
• Device Lot Number: 15825768
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/06/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/24/2013
• 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
• Treatment: GUIDE WIRE: AMPLATZ (COOK); INTRODUCER SHEATH: 6FR DESTINATION (TERUMO)