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

Model Number H74939295700410

Device Problems Premature Activation (1484); Activation, Positioning or Separation Problem (2906)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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 file (b)(4).

Event Description

It was reported that partial stent deployment occurred.A 7x40 75 cm eluvia¿ drug-eluting vascular stent system was selected for a procedure in the superficial femoral artery (sfa).During the procedure, when the physician attempted to deploy the stent, the thumbwheel was blocked.The physician could not deploy the stent inside the patient and it was reported to be partially deployed.The stent was removed from the introducer.There were no patient complications reported and the patient was ok post-procedure.

Manufacturer Narrative

(b)(4).Updated: describe event or problem, manufacturer name, upn- search, device lot number, device expiration date, device avail.For eval?, returned to mfr.On, mfg site name, device returned to mfr.?, device evaluated by mfr.?, device manufactured date, evaluation summary attached, conclusion codes, result codes, method codes device evaluated by mfr: returned product consisted of an eluvia sds.The shaft and handle were examined.The device returned with the stent partially deployed approximately 11mm from the marker band.The outer sheath showed some slight buckling at the nosecone.The mid-shaft showed no damage.The yellow thumbwheel lock was returned on the device.After inspection for damage, it was decided to rotate the thumbwheel and try and deploy the stent.The stent deployed as designed with no issue.The handle was opened to investigate for internal damage, no damage was noticed.There were no non-conformance's with this device in addition to the buckled shaft and the partially/inadvertent deployed stent.The investigation conclusion is handling damage as the complaint was caused by handling of the device or portion of the device without direct patient contact.(b)(4).

Event Description

It was further reported that the stent did not partially deploy inside the patient.When the stent package was opened, the stent was already partially deployed.The stent was not used on the patient and the procedure was completed with another eluvia without issues.

• Brand Name: ELUVIA¿ DRUG-ELUTING VASCULAR STENT SYSTEM
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY; one scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC - GALWAY
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 7030375
• MDR Text Key: 92842109
• Report Number: 2134265-2017-10815
• 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,Followup
• Report Date: 10/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/05/2018
• Device Model Number: H74939295700410
• Device Catalogue Number: 39295-70041
• Device Lot Number: 20823851
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/28/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/04/2017
• 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