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 Codes	Activation, Positioning or Separation Problem (2906); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/21/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the stent was partially deployed, and was stretched as a result.The eluvia was selected for use in the peripheral angiogram procedure to treat peripheral artery disease (pad).The target lesion within the proximal superficial femoral artery (sfa) was reportedly 100 percent stenosed.The patient underwent laser atherectomy and percutaneous transluminal angioplasty (pta) with a sterling balloon.The eluvia was being deployed at the proximal sfa, where one half of the stent was realigning a previously placed stent of unknown origin.During eluvia deployment, approximately 10mm of the stent would not unsheathe from the catheter.The physician pulled the pull grip slowly and evenly, but the issue persisted.The physician pulled back on the handle of the stent, and the stent could be seen stretching on the angiogram.The outer blue stabilizing shaft was pulled back and the distal end of the stent was unsheathed.As a result of troubleshooting, the distal end of the stent was stretched into the common femoral by an additional 10-20cm.Post pta of the stent was completed, and there were no dissections or flow disturbances.The patient had significantly improved flow compared to start of procedure, and there were no reported adverse consequences to the patient.
Additional Manufacturer Narrative
Device media analysis: returned product consisted of an eluvia self-expanding stent system with an unknown 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 handle was separated.The outer sheath was kinked at the nosecone.There were multiple kinks along the proximal inner.Microscopic examination revealed no additional damages.Inspection of the remainder of the device revealed no other damage or irregularities.Product analysis found damage that would have contributed to the deployment issue and stent deformation.
Event or Problem Description
It was reported that the stent was partially deployed, and was stretched as a result.The eluvia was selected for use in the peripheral angiogram procedure to treat peripheral artery disease (pad).The target lesion within the proximal superficial femoral artery (sfa) was reportedly 100 percent stenosed.The patient underwent laser atherectomy and percutaneous transluminal angioplasty (pta) with a sterling balloon.The eluvia was being deployed at the proximal sfa, where one half of the stent was realigning a previously placed stent of unknown origin.During eluvia deployment, approximately 10mm of the stent would not unsheathe from the catheter.The physician pulled the pull grip slowly and evenly, but the issue persisted.The physician pulled back on the handle of the stent, and the stent could be seen stretching on the angiogram.The outer blue stabilizing shaft was pulled back and the distal end of the stent was unsheathed.As a result of troubleshooting, the distal end of the stent was stretched into the common femoral by an additional 10-20cm.Post pta of the stent was completed, and there were no dissections or flow disturbances.The patient had significantly improved flow compared to start of procedure, and there were no reported adverse consequences to the patient.

• Brand Name: ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM
• Common Device Name: 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: 15951555
• Report Number: 2124215-2022-50285
• Device Sequence Number: 7427188
• Product Code: NIU
• UDI-Device Identifier: 08714729876731
• UDI-Public: 08714729876731
• Combination Product (Y/N): Y
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: P180011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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): 01/06/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/10/2024
• Device Model Number: 24657
• Device Catalogue Number: 24657
• Device Lot Number: 0029211861
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/21/2022
• Supplement Date Received by Manufacturer: 12/15/2022
• Initial Report FDA Received Date: 12/09/2022
• Supplement Report FDA Received Date: 01/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/11/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown