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

Model Number 24653

Device Problem Positioning Problem (3009)

Patient Problem No Code Available (3191)

Event Date 10/07/2019

Event Type  Injury  

Event Description

It was reported that the stent deployed in the wrong location.A 7x120x75 eluvia drug-eluting vascular stent system was selected for a procedure in the heavily calcified, non-tortuous, 40-50% stenosed superficial femoral artery (sfa).During the procedure, the delivery system was advanced over a guidewire and positioned in the usual way over the lesion.Deployment was initiated with the thumbwheel.After a few centimeters of deployment, the entire stent launched forward uncontrollably off of the delivery system.The stent deployed in the wrong location.An additional eluvia stent was placed which resulted in a satisfactory result for the patient.There were no patient complications and the patient status was good post procedure.

Manufacturer Narrative

Device evaluated by mfr: returned product consisted of an eluvia self-expanding stent system.The inner liner and tip of the device was checked for damage.Visual examination revealed a kink to the outer sheath at the nosecone.There is a kink to the inner liner 13.8cm from the tip.Microscopic examination revealed no additional damages.Inspection of the remainder of the device, revealed no other damage or irregularities.

Event Description

It was reported that the stent deployed in the wrong location.A 7x120x75 eluvia drug-eluting vascular stent system was selected for a procedure in the heavily calcified, non-tortuous, 40-50% stenosed superficial femoral artery (sfa).During the procedure, the delivery system was advanced over a guidewire and positioned in the usual way over the lesion.Deployment was initiated with the thumbwheel.After a few centimeters of deployment, the entire stent launched forward uncontrollably off of the delivery system.The stent deployed in the wrong location.An additional eluvia stent was placed which resulted in a satisfactory result for the patient.There were no patient complications and the patient status was good post procedure.

• 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: 9266058
• MDR Text Key: 164620981
• Report Number: 2134265-2019-13263
• 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: 11/19/2019

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 Model Number: 24653
• Device Catalogue Number: 24653
• Device Lot Number: 0023447159
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2019
• Initial Date Manufacturer Received: 10/10/2019
• Initial Date FDA Received: 11/01/2019
• Supplement Dates Manufacturer Received: 11/19/2019
• Supplement Dates FDA Received: 11/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention