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

Model Number 24653

Device Problems Premature Activation (1484); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/12/2020

Event Type  malfunction  

Event Description

It was reported that inadvertent deployment and stent damage occurred.The severely stenosed target lesion was located in the superficial femoral artery (sfa).A 6x120, 130cm eluvia drug-eluting vascular stent system was selected for use.During the insertion of the catheter along the guidewire, the stent extended outside the patient's body and changed into an unusable condition.The lever or fixture on the stent was untouched and unfolded in the process of pushing the catheter.The procedure was completed using another of the same device.There were no patient complications.

Manufacturer Narrative

Device evaluated by mfr: returned product consisted of an eluvia self-expanding stent system.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 stent was partially deployed 13mm from the distal end of the middle 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 inadvertent deployment and stent damage occurred.The severely stenosed target lesion was located in the superficial femoral artery (sfa).A 6x120, 130cm eluvia drug-eluting vascular stent system was selected for use.During the insertion of the catheter along the guidewire, the stent extended outside the patient's body and changed into an unusable condition.The lever or fixture on the stent was untouched and unfolded in the process of pushing the catheter.The procedure was completed using another of the same device.There were no patient complications.

• 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: 9910060
• MDR Text Key: 185970395
• Report Number: 2134265-2020-04108
• 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: 05/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/23/2021
• Device Model Number: 24653
• Device Catalogue Number: 24653
• Device Lot Number: 0024261609
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/14/2020
• Date Manufacturer Received: 04/30/2020
• Patient Sequence Number: 1
• Patient Age: 70 YR