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	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/30/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the catheter broke.A 6 x 100 x 130 eluvia self-expanding stent was selected for use.The stent was implanted in the superficial femoral artery (sfa) without incident.Upon removal of the stent delivery system from the patient, the catheter broke.The procedure was completed, and the patient condition post-procedure was reported as stable.
Additional Manufacturer Narrative
B3: date of event was corrected from (b)(6) 2020 to (b)(6) 2020.Device evaluated by mfr: visual examination revealed multiple kinks to the outer sheath.The inner liner is kinked 75mm from the tip.The inner liner, proximal inner, and tip is separated from the device.Microscopic examination revealed no additional damages.The handle was open to verify how the inner liner separated from the clip.The cuff bond was found inside the handle.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis confirmed the inner liner was pulled through the cuff bond.
Event or Problem Description
It was reported that the catheter broke.A 6x100x130 eluvia self-expanding stent was selected for use.The stent was implanted in the superficial femoral artery (sfa) without incident.Upon removal of the stent delivery system from the patient, the catheter broke.The procedure was completed, and the patient condition post-procedure was reported as stable.

• 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: 10326112
• Report Number: 2134265-2020-09915
• Device Sequence Number: 3209767
• Product Code: NIU
• UDI-Device Identifier: 08714729876601
• UDI-Public: 08714729876601
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P180011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/25/2020

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: 12/29/2020
• Device Model Number: 24657
• Device Catalogue Number: 24657
• Device Lot Number: 0024112643
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2020
• Initial Date Received by Manufacturer: 07/01/2020
• Supplement Date Received by Manufacturer: 08/13/2020
• Initial Report FDA Received Date: 07/27/2020
• Supplement Report FDA Received Date: 08/25/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1