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

Model Number H74939295601510

Device Problems Entrapment of Device (1212); Stretched (1601); Activation, Positioning or Separation Problem (2906)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/03/2017

Event Type  Injury  

Manufacturer Narrative

Device is combination product.(b)(4).

Event Description

It was reported that the stent partially deployed and the stent elongated.The patient presented with thrombus in a non bsc stent that was previously implanted 3 months ago located in the femoral artery.The thrombus was successfully removed using angiojet and a 6x150 130 cm eluvia¿ drug-eluting vascular stent system was then selected for use and advanced over a.035¿ zipwire to overlap the non bsc stent 10mm.Stent deployment was initiated and the thumbwheel was used until it stopped.The physician then used the pull grip to finish deployment.Elevated force and a strong pull was required to release the stent using the pull grip.A 6mm diameter x 15mm long balloon was used then to post dilate the stent.The physician reported that the stent elongated significantly as it appeared longer than the post-dilation balloon.The procedure continued with angioplasty on more distal vessels and the procedure was completed.The patient's condition was stable and control images looked well.This product is only ous approved but it is similar to an approved us device.

Manufacturer Narrative

(b)(4).Device evaluated by mfr.: returned product consisted of an eluvia self-expanding stent delivery system (sds) with a.035 zipwire guidewire stuck in the device.The outer shaft, mid-shaft, proximal liner and the remainder of the device were checked for damage.A.035 zipwire guidewire was stuck in the device upon receipt.The guidewire was protruding from the distal end approximately 19cm and protruding from the proximal end approximately 79cm.Visual examination showed no damage to the outer sheath or the mid-shaft.The thumbwheel was loose.The pull rack was locked.The handle was opened during investigation.The proximal inner and inner liner showed severe prolapsing.The pull rack showed damage on the 1st tooth.The thumbwheel showed no damage.The stent was not returned so the damage could not be confirmed.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.The most probable cause of the reported difficulties may be due to interaction with another device.(b)(4).

Event Description

It was further reported that at the end of the procedure when the delivery system was being cleaned for shipping that the eluvia was noted to be stuck on the wire.The guidewire may have became stuck when the physician was deploying the stent, but it may have been that it was dry post-procedure and therefore hard to remove from the delivery system.

• 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: 6981230
• MDR Text Key: 90383420
• Report Number: 2134265-2017-10576
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): N
• Reporter Country Code: MX
• PMA/PMN Number: SIMILAR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Health Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 10/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/16/2018
• Device Model Number: H74939295601510
• Device Catalogue Number: 39295-60151
• Device Lot Number: 20478563
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/31/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/10/2017
• 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
• Patient Outcome(s): Required Intervention