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 Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/10/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the stent was deployed and found to be shorter than its labeled size, requiring additional intervention.A 6mm x 100mm x 130cm eluvia drug-eluting vascular stent system was selected for use in a superficial femoral artery (sfa) intervention.During the procedure, the stent was deployed, but it was noted to be shorter than 100mm.The device did not appear to be compressed or foreshortened.Using an 80mm balloon for reference, the deployed stent was thought to be 40mm in length.Another 6mm x 100 mm eluvia drug-eluting vascular stent system was selected for use and deployed across the previously placed shorter stent.The procedure was completed.No patient complications were reported.
Event or Problem Description
It was reported that the stent was deployed and found to be shorter than its labeled size, requiring additional intervention.A 6mm x 100mm x 130cm eluvia drug-eluting vascular stent system was selected for use in a superficial femoral artery (sfa) intervention.During the procedure, the stent was deployed, but it was noted to be shorter than 100mm.The device did not appear to be compressed or foreshortened.Using an 80mm balloon for reference, the deployed stent was thought to be 40mm in length.Another 6mm x 100 mm eluvia drug-eluting vascular stent system was selected for use and deployed across the previously placed shorter stent.The procedure was completed.No patient complications were reported.It was further clarified that the first eluvia was not deployed when it was observed to be shorter than the 100mm length it was supposed to be from the packaging.The stent was removed and discarded.
Additional Manufacturer Narrative
Device eval by manufacturer: media review of photos from the field revealed, the first photo is the stent and the second photo is the label.The photo of the stent does not show any measurements so the length of the stent cannot be determined.An eluvia self-expanding stent system was returned.The returned product batch number and size does not match the information on the label in the photo.The returned device also does not match the reported batch.The outer sheath, tip, inner sheath and remainder of the device were checked for damage.Visual examination revealed a kink to the outer sheath at the nosecone and at about 52.2cm from the nosecone.Microscopic examination revealed no additional damages.
Additional Manufacturer Narrative
Eval by mfg: the complaint device was not received for analysis; however, an image was provided.In review of the image, the size of the stent did appear to be shorter than 100mm.
Event or Problem Description
It was reported that the stent was deployed and found to be shorter than its labeled size, requiring additional intervention.A 6mm x 100mm x 130cm eluvia drug-eluting vascular stent system was selected for use in a superficial femoral artery (sfa) intervention.During the procedure, the stent was deployed, but it was noted to be shorter than 100mm.The device did not appear to be compressed or foreshortened.Using an 80mm balloon for reference, the deployed stent was thought to be 40mm in length.Another 6mm x 100 mm eluvia drug-eluting vascular stent system was selected for use and deployed across the previously placed shorter stent.The procedure was completed.No patient complications were reported.It was further clarified that the first eluvia was not deployed when it was observed to be shorter than the 100mm length it was supposed to be from the packaging.The stent was removed and discarded.

• 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
• MDR Report Key: 11037835
• Report Number: 2134265-2020-18123
• Device Sequence Number: 1265141
• Product Code: NIU
• UDI-Device Identifier: 08714729876601
• UDI-Public: 08714729876601
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P180011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/15/2021

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: 07/31/2021
• Device Model Number: 24657
• Device Catalogue Number: 24657
• Device Lot Number: 0025838357
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2021
• Initial Date Received by Manufacturer: 12/10/2020
• Supplement Date Received by Manufacturer: 01/07/2021; 02/17/2021
• Initial Report FDA Received Date: 12/18/2020
• Supplement Report FDA Received Date: 01/11/2021; 03/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention