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); Positioning Failure (1158)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device evaluated by mfr: the device has not been received for analysis.The batch number is unknown and the manufacturing records for the complaint device could not be reviewed.The most probable root cause is operational context as device performance was limited due to anatomical procedural factors.(b)(4).

Event Description

Same case as: 2134265-2016-11569.Partial deployment and deployment difficulties occurred.The target lesion had numerous tortuosities.It was reported that the 6x150 eluvia¿ drug-eluting vascular stent system was advanced via the "humeral" approach to the lesion.After approximately 4cm of deployment the thumbwheel stopped working and stent deployment was unable to be completed by utilizing the pull grip.The stent fractured and a piece of the stent remained inside of the patient.The portion of the stent was unable to be located.A second 6x150 eluvia stent was advanced by the "cross-over" approach.Deployment was initiated and after approximately 4cm the thumbwheel stopped working and deployment was unable to be completed by utilizing the pull grip.The entire device was removed without any negative consequences to the patient.There were no further patient complications required and the patient's status is fine.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: 6181727
• MDR Text Key: 62679471
• Report Number: 2134265-2016-11568
• 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
• Type of Report: Initial
• Report Date: 11/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: H74939295601510
• Device Catalogue Number: 39295-60151
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/25/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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