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	Premature Activation (1484)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	09/25/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the stent inadvertently deployed.A 7x80x130 cm eluvia drug-eluting vascular stent was selected for implantation in the left superficial femoral artery.During preparation of the device and before use inside the patient, the stent was inadvertently partially deployed upon removal of the device from the packaging.Approximately 3-5 mm of the stent was unsheathed and flared.The inadvertent deployment was noticed immediately, so the device was exchanged for a new device which was then successfully used.The patient experienced no adverse effects and everything was fine.
Event or Problem Description
It was reported that the stent inadvertently deployed.A 7x80x130 cm eluvia drug-eluting vascular stent was selected for implantation in the left superficial femoral artery.During preparation of the device and before use inside the patient, the stent was inadvertently partially deployed upon removal of the device from the packaging.Approximately 3-5 mm of the stent was unsheathed and flared.The inadvertent deployment was noticed immediately, so the device was exchanged for a new device which was then successfully used.The patient experienced no adverse effects and everything was fine.
Additional Manufacturer Narrative
Device analysis by mfr: the returned product consisted of an eluvia self-expanding stent system.Visual examination revealed that the stent is partially deployed approximately 6mm from the distal end of the middle sheath.There is a kink to the outer sheath at the nosecone, 2.8cm and 41.4cm from the nosecone.Microscopic examination revealed no additional damages.The lock and pull rack are still in the manufactured position.Inspection of the remainder of the device, revealed no other damage or irregularities.

• 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: 9191469
• Report Number: 2134265-2019-12424
• Device Sequence Number: 11276375
• Product Code: NIU
• UDI-Device Identifier: 08714729876717
• UDI-Public: 08714729876717
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: P180011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/30/2019

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 Model Number: 24657
• Device Catalogue Number: 24657
• Device Lot Number: 0023375928
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2019
• Initial Date Received by Manufacturer: 09/25/2019
• Supplement Date Received by Manufacturer: 10/23/2019
• Initial Report FDA Received Date: 10/15/2019
• Supplement Report FDA Received Date: 10/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1