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

Model Number H74939295600810

Device Problem Entrapment of Device (1212)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/23/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Returned product consisted of an eluvia self-expanding stent delivery system (sds) with a.035 guidewire stuck in the device.The outer shaft, mid-shaft, proximal liner and the remainder of the device were checked for damage.Visual examination showed a kink at the nosecone.The guidewire that was stuck in the device was protruding from the distal end approximately 25.5cm from the tip.The wire was protruding from the proximal end approximately 79cm from the handle.The stent was not returned.The handle was opened to inspect for further damage.It was noticed that the mid-shaft was buckled/damaged at the retainer clip.The inner liner was buckled/damaged around the guidewire at the clip area.With the buckled/damaged mid-shaft at the retainer clip around the guidewire and the inner liner buckled/damaged around the guidewire, this most likely contributed to the guide wire being stuck in the device.No damage to the proximal inner was noticed.No damage to the pull rack or the thumbwheel teeth.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.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 the delivery system was stuck on the wire.A 6x80x130 eluvia¿ drug-eluting vascular stent system was selected for a percutaneous transluminal angioplasty (pta) procedure.During the procedure, the stent was fully deployed.After deployment, the stent delivery system (sds) could not be removed because it was stuck on the.035 guidewire used.The sds and the guidewire were removed together.There were no patient complications and the procedure had a good outcome.

Manufacturer Narrative

Updated: describe event or problem.(b)(4).

Event Description

It was further reported that the lesion location was in the arteria femoral superficial (afs).

• Brand Name: ELUVIA¿ DRUG-ELUTING VASCULAR STENT SYSTEM
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC - MAPLE GROVE; one scimed place; maple grove MN 55311
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 7035550
• MDR Text Key: 92923029
• Report Number: 2134265-2017-11028
• 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
• Type of Report: Initial,Followup
• Report Date: 10/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2018
• Device Model Number: H74939295600810
• Device Catalogue Number: 39295-60081
• Device Lot Number: 19561900
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/23/2017
• Initial Date FDA Received: 11/15/2017
• Supplement Dates Manufacturer Received: 12/15/2017
• Supplement Dates FDA Received: 01/04/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/26/2016
• 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