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 Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/09/2023

Event Type  malfunction  

Manufacturer Narrative

A2: age at time of event: 18 years or older.Device eval / media analysis by manufacturer: the device was not returned for analysis as the stent was implanted.However, media was provided in the form of two videos.Both videos showed the stent being deployed.The bottom of the screen displayed what appeared to be the tip of the device, whereas the markerband on the sheath could be seen at the top of the screen.The stent did not appear to have opened evenly.

Event Description

It was reported that the stent partially deployed and stretched.A 6x120mm, 130 cm eluvia drug-eluting vascular stent system was selected for use to treat a vessel dissection.A contralateral approach was used to access the stenosed superficial femoral artery with a 6mm reference vessel diameter.Pre-dilation was performed with a 6x80mm, 135cm mustang balloon catheter.During deployment of the eluvia stent, the thumbwheel was turned until the end, but the stent could not be fully deployed.At the same time, the 0.018 v-18 guidewire was stuck with the delivery system.The pull grip was then used, but the stent could not be fully deployed.Instead, the whole system was pulled out to complete deployment.The stent structure elongated approximately 60mm.The procedure was completed with this device.No patient complications were reported, and the patient was stable following the procedure.

Manufacturer Narrative

A2: age at time of event: 18 years or older.Device eval by manufacturer: returned product consisted of an eluvia self-expanding stent system with a 0.014-inch guidewire stuck in the device.The stent was not returned as it was implanted.Media was provided in the form of two videos.Both videos showed the stent being deployed.The bottom of the screen displayed what appeared to be the tip of the device, whereas the markerband on the sheath could be seen at the top of the screen.The stent did not appear to have opened evenly.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.Microscopic examination revealed no additional damages.The handle was x-rayed, and the proximal inner was prolapsed.Product analysis found damage that would have contributed to the deployment issue, stent deformation, and guidewire entrapment.

Event Description

It was reported that the stent partially deployed and stretched.A 6x120mm, 130 cm eluvia drug-eluting vascular stent system was selected for use to treat a vessel dissection.A contralateral approach was used to access the stenosed superficial femoral artery with a 6mm reference vessel diameter.Pre-dilation was performed with a 6x80mm, 135cm mustang balloon catheter.During deployment of the eluvia stent, the thumbwheel was turned until the end, but the stent could not be fully deployed.At the same time, the 0.018 v-18 guidewire was stuck with the delivery system.The pull grip was then used, but the stent could not be fully deployed.Instead, the whole system was pulled out to complete deployment.The stent structure elongated approximately 60mm.The procedure was completed with this device.No patient complications were reported, and the patient was stable following the procedure.It was further reported that the eluvia delivery system was stuck with a non-boston scientific guidewire, not a v-18 guidewire.

• Brand Name: ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 17691350
• MDR Text Key: 322745268
• Report Number: 2124215-2023-47378
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): Y
• Reporter Country Code: TW
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/05/2023
• Device Model Number: 24653
• Device Catalogue Number: 24653
• Device Lot Number: 0028462757
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/05/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 0.018 V-18 GUIDEWIRE; ASAHI GLADIATOR GUIDEWIRE