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

Model Number 24653

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

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/07/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event Description

It was reported that partial deployment and stent damage occurred.The 100% stenosed target lesion was located in a severely tortuous and severely calcified right superficial femoral artery.A 6x120, 130 cm eluvia drug-eluting vascular stent system was selected for the peripheral vasodilation procedure.A 6 french guide sheath was placed and an attempt to cross the lesion with a.014 inch guidewire and microcatheter was made, but there was strong resistance due to the calcification.The vessel was sufficiently pre-dilated, so the.014 inch guidewire was delivered.The stent system was delivered with slight resistance and stent placement was performed.When the thumbwheel was rotated, the resistance became heavier and the speed at which the middle sheath deployed became slower, but the thumbwheel continued to rotate until it spun out and the white arrow was observed on the pull grip.However, the remaining 2 centimeters of the stent had not deployed and remained in between the middle sheath and inner shaft.The pull grip slowly pulled out, and the middle sheath did not move.The entire system was carefully pulled and the remaining 2 centimeters of the stent slowly deployed.It was noted that the stent became crimped by post-expansion, but was still able to be implanted almost in its exact intended location.The confirmation imaging was good and the procedure was completed with the device without adverse effects.There were no patient complications.

Manufacturer Narrative

E1: initial reporter facility name: (b)(6).Device analysis by manufacturer: 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.Serial number (b)(6) was received; a 7 x 40 device.Visual examination revealed the eluvia was received with an unknown guidewire still inserted.A kink at the nosecone was seen.The thumbwheel lock and hydrating luer were removed and not returned.The pull grip was fully extended.The stent was deployed and not returned.The od of the guidewire was measured at 0.0142.X-ray analysis confirmed a prolapse of the inner in the handle.Product analysis found damage that would have contributed to deployment issues.

Event Description

It was reported that partial deployment and stent damage occurred.The 100% stenosed target lesion was located in a severely tortuous and severely calcified right superficial femoral artery.A 6x120, 130 cm eluvia drug-eluting vascular stent system was selected for the peripheral vasodilation procedure.A 6 french guide sheath was placed and an attempt to cross the lesion with a.014 inch guidewire and microcatheter was made, but there was strong resistance due to the calcification.The vessel was sufficiently pre-dilated, so the.014 inch guidewire was delivered.The stent system was delivered with slight resistance and stent placement was performed.When the thumbwheel was rotated, the resistance became heavier and the speed at which the middle sheath deployed became slower, but the thumbwheel continued to rotate until it spun out and the white arrow was observed on the pull grip.However, the remaining 2 centimeters of the stent had not deployed and remained in between the middle sheath and inner shaft.The pull grip slowly pulled out, and the middle sheath did not move.The entire system was carefully pulled and the remaining 2 centimeters of the stent slowly deployed.It was noted that the stent became crimped by post-expansion, but was still able to be implanted almost in its exact intended location.The confirmation imaging was good and the procedure was completed with the device without adverse effects.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
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 14274402
• MDR Text Key: 290796525
• Report Number: 2134265-2022-04874
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): Y
• Reporter Country Code: JA
• PMA/PMN Number: P180011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/10/2023
• Device Model Number: 24653
• Device Catalogue Number: 24653
• Device Lot Number: 0027165318
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/12/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/10/2021
• 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