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 05/27/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event Description

It was reported that the stent partially deployed and entrapment on the guidewire occurred.The 100% stenosed target lesion was located in the moderately tortuous and moderately calcified superficial femoral artery (sfa).Contralateral approach was performed with a 6f guiding sheath.A 6x120x130 cm eluvia drug-eluting vascular stent system was selected for use.During deployment, the thumbwheel was turned completely; however, the stent could not be fully placed.The shaft was pulled and the stent deployed.During removal, the non-bsc guidewire became stuck somewhere inside the shaft.The device was removed together with the guidewire.A kink in the shaft at the proximal part of the handle occurred during storage after removal from the patient.There were no patient complications reported.

Manufacturer Narrative

E1: initial reporter state- (b)(6).Device evaluated by mfr: returned product consisted of an eluvia self-expanding stent system from 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.Microscopic examination revealed no additional damages.The stent did not return for analysis.Inspection of the remainder of the device, revealed no other damage or irregularities.

Event Description

It was reported that the stent partially deployed and entrapment on the guidewire occurred.The 100% stenosed target lesion was located in the moderately tortuous and moderately calcified superficial femoral artery (sfa).Contralateral approach was performed with a 6f guiding sheath.A 6x120x130 cm eluvia drug-eluting vascular stent system was selected for use.During deployment, the thumbwheel was turned completely; however, the stent could not be fully placed.The shaft was pulled and the stent deployed.During removal, the non-bsc guidewire became stuck somewhere inside the shaft.The device was removed together with the guidewire.A kink in the shaft at the proximal part of the handle occurred during storage after removal from the patient.There were no patient complications reported.

• 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: 10179801
• MDR Text Key: 195954100
• Report Number: 2134265-2020-08126
• 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: 08/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 24653
• Device Catalogue Number: 24653
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2020
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: GUIDEWIRE: 0.014 CHEVALIER FLOPPY; GUIDEWIRE: 0.014 CHEVALIER FLOPPY; INTRODUCER SHEATH: 6F PARENT; INTRODUCER SHEATH: 6F PARENT; GUIDEWIRE: 0.014 CHEVALIER FLOPPY; INTRODUCER SHEATH: 6F PARENT