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

Model Number 24653

Device Problems Entrapment of Device (1212); Activation, Positioning or Separation Problem (2906); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/18/2020

Event Type  Injury  

Event Description

It was reported that the stent partially deployed and stretched.The 75% stenosed target lesion was located in the moderately tortuous right superficial femoral artery (sfa).Contralateral approach was performed with a non-bsc 6f introducer sheath.The lesion was pre-dilated.During deployment of a 6 x 120 x 130 eluvia drug-eluting vascular stent system over a 0.014 inch non-bsc guidewire, the thumbwheel was spinning idle midway.The shaft was pulled and the stent deployed; however the stent was stretched.During removal, the stent delivery shaft and the guidewire became stuck.The catheter and the guidewire were removed together as one unit.A 6 x 40 eluvia stent was placed over the previously placed stretched stent.There were no patient complications and the patient's status was good.

Manufacturer Narrative

Device evaluated by mfr: the returned product consisted of an eluvia self-expanding stent system with a 0.014 inch guidewire stuck in 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 outer sheath at the nosecone.The proximal inner is prolapsed inside the handle.There are multiple small bends throughout the outer sheath.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 partially deployed and stretched.The 75% stenosed target lesion was located in the moderately tortuous right superficial femoral artery (sfa).Contralateral approach was performed with a non-bsc 6f introducer sheath.The lesion was pre-dilated.During deployment of a 6x120x130 eluvia drug-eluting vascular stent system over a 0.014 inch guidewire, the thumbwheel was spinning idle midway.The shaft was pulled and the stent deployed; however the stent was stretched.During removal, the stent delivery shaft and the guidewire became stuck.The catheter and the guidewire were removed together as one unit.A 6x40 eluvia stent was placed over the previously placed stretched stent.There were no patient complications and the patient's status was good.

• 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: 10133360
• MDR Text Key: 194488665
• Report Number: 2134265-2020-07668
• 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,distri
• Type of Report: Initial,Followup
• Report Date: 07/31/2020

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: 09/03/2021
• Device Model Number: 24653
• Device Catalogue Number: 24653
• Device Lot Number: 0024546859
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2020
• Initial Date Manufacturer Received: 05/18/2020
• Initial Date FDA Received: 06/09/2020
• Supplement Dates Manufacturer Received: 07/13/2020
• Supplement Dates FDA Received: 07/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: GUIDEWIRE: CRUISE 300CM 0.014 INCH; GUIDEWIRE: CRUISE 300CM 0.014 INCH; INTRODUCER SHEATH: PARENT 6F; INTRODUCER SHEATH: PARENT 6F; GUIDEWIRE: CRUISE 300CM 0.014 INCH; INTRODUCER SHEATH: PARENT 6F
• Patient Outcome(s): Required Intervention