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); Difficult or Delayed Activation (2577); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/04/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event Description

It was reported that stent damage occurred.The 95% stenosed target lesion was located in the moderately calcified and severely tortuous superficial femoral artery (sfa).A 6 x 120 x 130 eluvia drug-eluting vascular stent system was advanced via a contralateral approach over a.014 non-bsc guidewire.The angle on the contralateral side was also steep.During deployment, the wheel was hard to turn, but was able to be placed.The distal side of the stent became slightly denser upon deployment.Upon removal, the delivery system became entrapped on the guidewire.The delivery system and the guidewire were removed together.The guidewire crossed again and two eluvia stents were placed.The procedure was completed.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 with a 0.014" 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 and 43.8cm from the nosecone.Microscopic examination revealed no additional damages.The device was x-ray and the proximal inner was prolapsed.Inspection of the remainder of the device, revealed no other damage or irregularities.

Event Description

It was reported that partial deployment occurred.The 95% stenosed target lesion was located in the moderately calcified and severely tortuous superficial femoral artery (sfa).A 6 x 120 x 130 eluvia drug-eluting vascular stent system was advanced contralateral over a.0014 guidewire.The angle on the contralateral side was also steep.During deployment, the wheel was hard to turn.The stent was placed; however, the distal side became slightly denser.Upon removal, the delivery system and the guidewire became one.The delivery system and the guidewire were removed together.The guidewire crossed again and two eluvia stents were placed.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: 10189723
• MDR Text Key: 196269940
• Report Number: 2134265-2020-08180
• 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: 08/11/2020

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: 11/14/2021
• Device Model Number: 24653
• Device Catalogue Number: 24653
• Device Lot Number: 0024941648
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2020
• Initial Date Manufacturer Received: 06/04/2020
• Initial Date FDA Received: 06/24/2020
• Supplement Dates Manufacturer Received: 07/30/2020
• Supplement Dates FDA Received: 08/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ASAHI INTEC 0.014 GUIDEWIRE; ASAHI INTEC 0.014 GUIDEWIRE; TERUMO DESTINATION SHEATH 45CM; TERUMO DESTINATION SHEATH 45CM; ASAHI INTEC 0.014 GUIDEWIRE; TERUMO DESTINATION SHEATH 45CM