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

Model Number H74939295601510

Device Problems Difficult or Delayed Positioning (1157); Stretched (1601); Activation, Positioning or Separation Problem (2906)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/12/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device evaluated by manufacturer: the device was not returned for analysis.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause was unable to be determined.(b)(4).

Event Description

It was reported that deployment difficulties and partial stent deployment occurred.Vascular access was obtained via a contralateral approach.The target lesion was highly stenosed with low calcification and tortuosity.A 6x150x30cm eluvia¿ drug-eluting stent was selected for a percutaneous transluminal angioplasty procedure.The lesion was not pre-dilated.High force was required to turn the thumbwheel during stent deployment and only 1cm of the stent deployed.The eluvia¿ stent was then removed in which it was reported the stent stretched out of the sheath.The procedure was completed with another of the same device.There were no patient complications and the patient status is stable.This product is only ous approved but it is similar to an approved us device.

• 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: 6552861
• MDR Text Key: 74700155
• Report Number: 2134265-2017-04326
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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
• Report Date: 04/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2018
• Device Model Number: H74939295601510
• Device Catalogue Number: 39295-60151
• Device Lot Number: 19834884
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/13/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/24/2016
• 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
• Treatment: TERUMO DESTINATION 6FR. 90 CM INTRODUCER SHEATH; TERUMO RADIFOCUS 0.035 GUIDEWIRE