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

Model Number H74939295701510

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/04/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device evaluated by mfr: it is indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.(b)(4).

Event Description

It was reported that partial stent deployment and stent elongation occurred.The greater than 70% stenosed, moderately calcified, and moderately tortuous target lesion was located in the superficial femoral artery (sfa).Following pre-dilation, a 7 x 150 x 130 eluvia¿ drug-eluting vascular stent system was advanced anterograde over a.035 terumo guidewire and stent deployment was initiated.After approximately 50% of the stent being deployed, the thumbwheel blocked and was no longer working.The pull grip was used to deploy the stent; however force was required to deploy the stent resulting in the implanted stent being elongated.There were no patient complications and there was no issue/consequence for the patient.

Manufacturer Narrative

Updated: event date, describe event or problem, if implanted, give date, if remedial action, type, 21 usc 360i(f) number.Bsc id (b)(4).

Event Description

It was further reported that the stent stretched to 220 mm and covered an important collateral branch.No further action was taken to the elongated stent.

• 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: 6988945
• MDR Text Key: 91207938
• Report Number: 2134265-2017-10466
• 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: 10/09/2017

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: 11/26/2018
• Device Model Number: H74939295701510
• Device Catalogue Number: 39295-70151
• Device Lot Number: 0020742397
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/09/2017
• Initial Date FDA Received: 10/30/2017
• Supplement Dates Manufacturer Received: 11/02/2017
• Supplement Dates FDA Received: 11/28/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/15/2017
• 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