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

Model Number	24657
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/17/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the deployed stent measurements did not match the device labeling, and an additional device had to be deployed to adequately treat the patient.An eluvia drug-eluting vascular stent system, 7x120, 130 cm was selected for use in the arterial stenting procedure.The patient had previous stents placed, but there were gaps in their coverage of the vessel and new stenosis had developed in those gaps.The eluvia 7x120 was selected to use the entire stent length to cover the previously implanted stents and to cover the gaps in coverage.When loading the eluvia on the wire, the physician assessed the markers were exactly the length appropriate for the procedure.Deployment began, and the physician noted that the markers on the delivery system appeared to be moving and not matching up with the correct length of the stent.Once the stent was fully deployed, the stent only measured approximately 60 mm in length on fluoroscopy.An additional non-boston scientific stent was needed to finish covering the target location.The procedure was completed and there were no reported adverse consequences to the patient.
Additional Manufacturer Narrative
Media analysis: the complaint device was not received for analysis.Media was provided in the form of four photos.The first photo was the shelf box label.The second photo showed what appeared to be four implanted stents.There was one stent with visible radiopaque markers, and it was measured to be approximately 61.69 mm in length.The third photo showed the four stents again without the measurements.The fourth photo appeared to show the blood flow through the stented portions of the patient anatomy.
Event or Problem Description
It was reported that the deployed stent measurements did not match the device labeling, and an additional device had to be deployed to adequately treat the patient.An eluvia drug-eluting vascular stent system, 7x120, 130 cm was selected for use in the arterial stenting procedure.The patient had previous stents placed, but there were gaps in their coverage of the vessel and new stenosis had developed in those gaps.The eluvia 7x120 was selected to use the entire stent length to cover the previously implanted stents and to cover the gaps in coverage.When loading the eluvia on the wire, the physician assessed the markers were exactly the length appropriate for the procedure.Deployment began, and the physician noted that the markers on the delivery system appeared to be moving and not matching up with the correct length of the stent.Once the stent was fully deployed, the stent only measured approximately 60 mm in length on fluoroscopy.The customer hypothesized that either the box was mislabeled, or the incorrect stent length was loaded onto the incorrect stent delivery system.An additional non-bsc stent was needed to finish covering the target location.The procedure was completed and there were no reported adverse consequences to the patient.It was further reported that the target lesion was located in the right leg.

• Brand Name: ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM
• Common Device Name: 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: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 16728214
• Report Number: 2124215-2023-16666
• Device Sequence Number: 6862416
• Product Code: NIU
• UDI-Device Identifier: 08714729876731
• UDI-Public: 08714729876731
• Combination Product (Y/N): Y
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: P180011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/27/2023
• Device Model Number: 24657
• Device Catalogue Number: 24657
• Device Lot Number: 0027964208
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/17/2023
• Supplement Date Received by Manufacturer: 04/11/2023
• Initial Report FDA Received Date: 04/12/2023
• Supplement Report FDA Received Date: 05/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/27/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown