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 Fracture (1260); Activation, Positioning or Separation Problem (2906)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 10/19/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

Partial stent deployment was reported and the stent fractured.Using a contralateral approach, the target lesion was pre-dilated.The physician selected the use of a 6x150, 130 cm eluvia" drug-eluting vascular stent system in the totally occluded superficial femoral artery (sfa).After several centimeters of the stent being deployed, the stent became impossible to complete deployment.The stent ended up fracturing.The fractured portion of the eluvia stent was cover with a non bsc stent to complete the procedure.No patient complications were reported.

Manufacturer Narrative

Device evaluated by manufacturer: returned product consisted of an eluvia sds.There was blood on the outer surface of the device and in the lumens.The shaft and handle were examined.There were multiple locations throughout the sds that were buckled.There was 120mm of the stent in the lumen of the catheter which indicates that 30mm was deployed/separated.The separated/fractured end of the stent was stretched, indicating that the stent was under tension prior to separating.The rack and thumb wheel moved freely.The handle was opened during analysis.The middle sheath was found to have been pulled out of the retainer clip.There was no evidence of any product quality deficiencies.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause is operational context as device performance was limited due to anatomical procedural factors.(b)(4).

Event Description

Partial stent deployment was reported and the stent fractured.Using a contralateral approach, the target lesion was pre-dilated.The physician selected the use of a 6x150, 130 cm eluvia¿ drug-eluting vascular stent system in the totally occluded superficial femoral artery (sfa).After several centimeters of the stent being deployed, the stent became impossible to complete deployment.The stent ended up fracturing.The fractured portion of the eluvia stent was cover with a non bsc stent to complete the procedure.No patient complications were reported.

• 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: 6106706
• MDR Text Key: 60032169
• Report Number: 2134265-2016-10208
• 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: 10/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2017
• Device Model Number: H74939295601510
• Device Catalogue Number: 39295-60151
• Device Lot Number: 19397817
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/19/2016
• Initial Date FDA Received: 11/16/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/12/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/12/2016
• 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: COOK 45 CM STRAIGHT SHEATH; TERUMO 35 NORMAL GUIDEWIRE
• Patient Outcome(s): Required Intervention