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

Model Number H74939295701510

Device Problems Fracture (1260); Stretched (1601); Activation, Positioning or Separation Problem (2906)

Patient Problems Thrombosis (2100); Device Embedded In Tissue or Plaque (3165)

Event Date 01/18/2017

Event Type  Injury  

Manufacturer Narrative

Initial reporter phone: (b)(6).(b)(4).

Event Description

It was reported that deployment difficulties, stent fracture and stent damage occurred.A 7x150,130 cm eluvia¿ drug-eluting vascular stent system was advanced to the lesion and deployment was initiated, however the stent could not be released from the delivery system.During an attempt to retrieve the stent, it elongated and broke.Approximately 4/5 of the stent was retrieved, however a portion of the stent remained in the patient.Another stent was implanted.Thrombosis with complete occlusion of the leg occurred.A lysis catheter was placed to treat the thrombus.There were no further patient complications reported and the patient was stable following the procedure.This product is only ous approved but it is similar to an approved us device.

Manufacturer Narrative

Age at time of event: 18 years or older.Device evaluated by mfr: returned product consisted of an eluvia self-expanding stent delivery system (sds) with a separated piece of stent.The outer shaft, middle shaft, inner shaft and the remainder of the device were checked for damage.The shaft showed a kink at the nosecone.The outer sheath showed some buckling approximately 18 to 22cm from the sheath end.The device handle was opened.There was no damage from the customer on the middle sheath; however, during the inspection and the disassembly of the device, the middle sheath suffered some kinking approximately 6.5 to 7cm from the marker band.There was also some buckling on the middle sheath approximately 101cm from the marker band.This damage was caused by the outer sheath and the middle sheath sticking together and the tensile force it took to pull the two apart caused the damage to the components.The inner liner and the proximal inner were both disassembled from the device as well and there was no customer damage done; however, during this disassembly the inner liner was kinked.When received it was noticed that the stent was in the device but it was partially deployed sticking out the distal end.When the device was disassembled during analysis the stent was removed from the device.It was also noticed that a partial piece of the stent had been returned in a separate bag.The partial piece that was in the separate bag was fractured from the full stent and it was approximately 25cm in length.The partial stent piece was part of the same stent that was removed from the device.Due to the extreme damage of the stent it is impossible to determine if the complete stent was returned.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The root cause is anticipated procedural complications as this event is a known physiological effect of the procedure and is noted within the dfu.(b)(4).

Event Description

It was further reported that the lesion was 100% stenosed, straight, and severely calcified.The lesion was predilated and the eluvia¿ device was advanced to the lesion ipsilaterally.Treatment of the thrombosis involved lysis overnight to remove the thrombus with a retrieval catheter.The patient was "well" post-procedure.

• 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: 6314624
• MDR Text Key: 66916906
• Report Number: 2134265-2017-00657
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): N
• 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: 01/18/2017

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: H74939295701510
• Device Catalogue Number: 39295-70151
• Device Lot Number: 19407621
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/18/2017
• Initial Date FDA Received: 02/09/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/09/2017
• 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
• Patient Outcome(s): Required Intervention