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)

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

Event Date 02/03/2022

Event Type  malfunction  

Manufacturer Narrative

Initial reporter address 1: (b)(6).

Event Description

It was reported that partial deployment occurred.A 100% stenosed target lesion was located in a moderately tortuous and moderately calcified right superficial femoral artery.Following pre-dilation with a balloon, a 7x120, 130cm eluvia drug-eluting vascular stent system was advanced into the lesion for endovascular therapy using a crossover approach.The stent was deployed with the thumbwheel halfway, and the thumbwheel was no longer operable.A pullback was attempted, but the stent would not expand.The device became entrapped on the guidewire.The entire system was to be removed, and as the guide catheter was pushed in, the entrapped wire was no longer entrapped.The partially deployed stent fully deployed.The procedure was completed with the same device.No damage to the device was reported.No patient complications were reported.

Manufacturer Narrative

Initial reporter address 1: (b)(6).

Event Description

It was reported that partial deployment occurred.A 100% stenosed target lesion was located in a moderately tortuous and moderately calcified right superficial femoral artery.Following pre-dilation with a balloon, a 7x120, 130cm eluvia drug-eluting vascular stent system was advanced into the lesion for endovascular therapy using a crossover approach.The stent was deployed with the thumbwheel halfway, and the thumbwheel was no longer operable.A pullback was attempted, but the stent would not expand.The device became entrapped on the guidewire.The entire system was to be removed, and as the guide catheter was pushed in, the entrapped wire was no longer entrapped.The partially deployed stent fully deployed.The procedure was completed with the same device.No damage to the device was reported.No patient complications were reported.

Manufacturer Narrative

E1 - initial reporter address 1: (b)(6).Device analysis by manufacturer: returned product consisted of an eluvia self-expanding stent system 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 that the sheath is kinked at the nosecone.Microscopic examination revealed no additional damages.The stent was deployed and did not return for analysis.The handle was x-rayed, and the proximal inner was prolapsed.Inspection of the remainder of the device, revealed no other damage or irregularities.Product analysis found damage that would have contributed to the froze on wire and deployment issues.

Event Description

It was reported that partial deployment occurred.A 100% stenosed target lesion was located in a moderately tortuous and moderately calcified right superficial femoral artery.Following pre-dilation with a balloon, a 7x120, 130cm eluvia drug-eluting vascular stent system was advanced into the lesion for endovascular therapy using a crossover approach.The stent was deployed with the thumbwheel halfway, and the thumbwheel was no longer operable.A pullback was attempted, but the stent would not expand.The device became entrapped on the guidewire.The entire system was to be removed, and as the guide catheter was pushed in, the entrapped wire was no longer entrapped.The partially deployed stent fully deployed.The procedure was completed with the same device.No damage to the device was reported.No patient complications were 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
• 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: 13595604
• MDR Text Key: 286118346
• Report Number: 2134265-2022-01968
• 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,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/30/2022

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: 06/30/2023
• Device Model Number: 24653
• Device Catalogue Number: 24653
• Device Lot Number: 0027715315
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/04/2022
• Initial Date FDA Received: 02/24/2022
• Supplement Dates Manufacturer Received: 03/08/2022
• Supplement Dates FDA Received: 03/31/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/30/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1