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

Model Number H74939295601570

Device Problems Detachment Of Device Component (1104); Fracture (1260); Stretched (1601); Activation, Positioning or Separation Problem (2906)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 09/13/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Device is a combination product.Device evaluated by mfr: the device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).

Event Description

It was reported the stent partially deployed, elongated, and fractured.A crossover approach was used to access the over 70% stenosed target lesion located in the very tortuous and calcified superficial femoral artery (sfa).Pre-dilation was performed with a mustang balloon.A 6x150 75 cm eluvia¿ drug-eluting vascular stent system, sheath, and standard stiff 0.035" wire were selected for use.During the procedure, eluvia deployment was initiated.After half of the stent deployed, the thumbwheel became blocked once the white arrow was visible and deployment could not be completed with the pull grip.The physician pulled the handle firmly to withdraw the whole system.The device was removed.The stent elongated and fractured.The 15 cm of the stent was removed blocked inside the delivery sheath and 2 cm remained in the patient.A broken inner shaft was also observed.Kinks were observed on the shaft after use.There were no further patient complications and the patient was ok though needed to be re-treated the following day.

Manufacturer Narrative

Device evaluated by mfr.: returned product consisted of an eluvia self-expanding stent delivery system (sds) with a.014 guidewire stuck in the device.The outer shaft, mid-shaft, proximal liner and the remainder of the device were checked for damage.The device showed a.014 guidewire stuck inside.The guidewire was protruding from the distal end approximately 58cm and protruding from the proximal end 146cm.Visual examination showed that the outer sheath showed a kink at the nosecone.The mid-shaft showed damage in the form of flattening approximately 4cm from the distal end of the outer sheath distally 21cm to the tip.The pull rack was locked in the handle.The thumbwheel was difficult to turn.The handle was opened for further investigation.The proximal inner and inner liner showed prolapsing damage.The pull rack showed damage on the 1st tooth.The thumbwheel showed blue residue from the pull rack and there was some slight damage.The stent was not returned with the device; however, photos provided from the customer site did confirm that the stent was fractured and damaged.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 interaction with another device.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 the stent partially deployed, elongated, and fractured.A crossover approach was used to access the over 70% stenosed target lesion located in the very tortuous and calcified superficial femoral artery (sfa).Pre-dilation was performed with a mustang balloon.A 6x150 75 cm eluvia drug-eluting vascular stent system, sheath, and standard stiff 0.035" wire were selected for use.During the procedure, eluvia deployment was initiated.After half of the stent deployed, the thumbwheel became blocked once the white arrow was visible and deployment could not be completed with the pull grip.The physician pulled the handle firmly to withdraw the whole system.The device was removed.The stent elongated and fractured.15 cm of the stent was removed blocked inside the delivery sheath and 2 cm remained in the patient.A broken inner shaft was also observed.Kinks were observed on the shaft after use.There were no further patient complications and the patient was ok though needed to be re-treated the following day.

• 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: 6926858
• MDR Text Key: 88861144
• Report Number: 2134265-2017-09728
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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,Followup
• Report Date: 09/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/26/2018
• Device Model Number: H74939295601570
• Device Catalogue Number: 39295-60157
• Device Lot Number: 20749451
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/24/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/16/2017
• 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): Other