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

Model Number 24653

Device Problems Difficult or Delayed Positioning (1157); Entrapment of Device (1212)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/12/2019

Event Type  malfunction  

Manufacturer Narrative

Age at time of event: 18 years or older.

Event Description

It was reported that the delivery system was stuck on the wire.A 7x120x130 eluvia self expanding stent was selected for a stenting procedure in the superficial femoral artery (sfa).The lesion was chronic total occlusion (cto) and the anatomy was moderately tortuous.Following pre-dilation, the eluvia was advanced ipsilateral over a 0.014 non-bsc guidewire and deployed.There was some difficulty with the thumbwheel, however the stent was fully deployed and not stretched or elongated.No additional maneuvers were required to deploy the stent.Following stent deployment, the delivery system became stuck on the guidewire.The devices were removed from the patient together.A new wire was inserted into the patient, and the remaining lesion was treated.The procedure was completed.There were no patient complications.

Event Description

It was reported that the delivery system was stuck on the wire.A 7x120x130 eluvia self expanding stent was selected for a stenting procedure in the superficial femoral artery (sfa).The lesion was chronic total occlusion (cto) and the anatomy was moderately tortuous.Following pre-dilation, the eluvia was advanced ipsilateral over a 0.014 non-bsc guidewire and deployed.There was some difficulty with the thumbwheel, however the stent was fully deployed and not stretched or elongated.No additional maneuvers were required to deploy the stent.Following stent deployment, the delivery system became stuck on the guidewire.The devices were removed from the patient together.A new wire was inserted into the patient, and the remaining lesion was treated.The procedure was completed.There were no patient complications.

Manufacturer Narrative

Age at time of event: 18 years or older.Device evaluated by mfr: returned product consisted of an eluvia self-expanding stent system with what appears to be the reported jupiter fc guidewire stuck inside the device.The outer sheath, tip, inner sheath and the remainder of the device were checked for damage.Visual examination revealed a kink to the nosecone.The stuck wire is a 0.014" guidewire so it is assumed to be the reported jupiter fc wire.The wire is sticking out 35.9cm from the tip and 89.8cm from the knob of the pull rack.The stent was not returned for product analysis.Microscopic examination revealed no additional damages.There is blood present on and in the device.Attempts to remove the wire were unsuccessful so the handle was opened to verify if there are additional damages causing the wire to be stuck.Once the handle was opened it was noticed that the proximal inner prolapsed.Inspection of the remainder of the device, revealed no other damage or irregularities.

• Brand Name: ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8566944
• MDR Text Key: 143682626
• Report Number: 2134265-2019-04295
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): N
• PMA/PMN Number: P180011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/07/2019

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: 10/24/2020
• Device Model Number: 24653
• Device Catalogue Number: 24653
• Device Lot Number: 0022964238
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2019
• Initial Date Manufacturer Received: 04/12/2019
• Initial Date FDA Received: 04/30/2019
• Supplement Dates Manufacturer Received: 05/02/2019
• Supplement Dates FDA Received: 05/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: JUPITER FC3 300CM .014 INCH GUIDEWIRE; JUPITER FC3 300CM .014 INCH GUIDEWIRE