MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY ELUVIA¿ DRUG-ELUTING VASCULAR STENT SYSTEM; STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING

Model Number H74939295601510

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/24/2017

Event Type  malfunction  

Manufacturer Narrative

Device is combination product.(b)(4).The eluvia self-expanding stent delivery system was returned with a.014 guidewire inside the device.The outer shaft, mid-shaft, proximal liner and the remainder of the device were checked for damage.The handle was previously opened when received.Visual examination showed that the outer sheath showed no damage.The mid-shaft showed no damage.The pull rack showed damage on the 1st tooth.The thumbwheel showed minor damage.The stent was not returned.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.The investigation conclusion is caused by other device as another device/drug/subsequent procedure caused the complaint event.The eluvia dfu states that a stiff 0.035 in guidewire is strongly recommended for deployment of the stent, especially for tortuous anatomy and contralateral approaches.Use of undersized guidewires may lead to insufficient support of the device which can compromise stent delivery (b)(4).

Event Description

It was reported that partial stent deployment occurred.The target lesion was located in the superficial femoral artery.A 6x150 130 cm eluvia¿ drug-eluting vascular stent system was advanced over a.014 guidewire and deployment initiated.After 60mm of stent deployment, the thumbwheel would not turn and the pull grip did not work.The physician then opened the handle on the delivery system and released the stent with no further problems.The procedure was completed and no patient complications were reported.

• Brand Name: ELUVIA¿ DRUG-ELUTING VASCULAR STENT SYSTEM
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING
• 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: 7035812
• MDR Text Key: 92931385
• Report Number: 2134265-2017-11046
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): N
• PMA/PMN Number: SIMILAR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 10/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/27/2018
• Device Model Number: H74939295601510
• Device Catalogue Number: 39295-60151
• Device Lot Number: 20590687
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/24/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/12/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 92169170-FA
• Patient Sequence Number: 1