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

Model Number 24657

Device Problems Fracture (1260); Failure to Advance (2524); Activation, Positioning or Separation Problem (2906)

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

Event Date 09/01/2022

Event Type  Injury  

Event Description

It was reported that the stent partially deployed and fractured, requiring additional devices to be implanted.The 100% stenosed target lesion was located in a severely calcified distal superficial femoral artery (sfa).The target lesion was predilated with a 4mm balloon.A 6x120, 130 cm eluvia drug-eluting vascular stent system was advanced contralaterally to the distal sfa for deployment; however, resistance was felt.As the stent was being deployed, the outer stent catheter did not fully retract, leaving a portion (about 1/3 to 1/2) of the stent undeployed and still in the deployment catheter.The thumb wheel was fully rotated and the handle was pulled, but when removing the catheter to try to get the remaining stent to deploy, the stent fractured.One half of the stent was deployed and the other half was still restrained in the delivery system.The non-deployed portion of the stent was removed, and the deployed portion remained in place.The vessel was predilated again, and additional eluvia stents were placed without any issues to complete the procedure.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
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15486066
• MDR Text Key: 300581737
• Report Number: 2124215-2022-36748
• Device Sequence Number: 1
• Product Code: NIU
• UDI-Device Identifier: 08714729876618
• UDI-Public: 08714729876618
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P180011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/27/2023
• Device Model Number: 24657
• Device Catalogue Number: 24657
• Device Lot Number: 0027949170
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/27/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR
• Patient Sex: Male