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 Consequences Or Impact To Patient (2199)
Date of Event	04/22/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is a combination product.
Event or Problem Description
It was reported that the stent prematurely deployed.A 6x100x130 eluvia drug-eluting vascular stent system was selected for a percutaneous transluminal angioplasty (pta) of the right superficial femoral artery (sfa) chronic total occlusion (cto).During the procedure, the first 2 stents were delivered successfully.When attempting to deliver the last stent, it deployed directly info the non-bsc sheath.The locking mechanism was still on the thumbwheel.There was no resistance when advancing the device through the sheath.The sheath was removed with the deployed stent in it, and replaced with another one.A new eluvia stent was placed and the procedure was completed.There were no patient complications.
Additional Manufacturer Narrative
Device is a combination product.Device evaluated by mfr: returned product consisted of an eluvia self-expanding stent system with a terumo introducer sheath.There appeared to be another eluvia device that is separated at the inner liner stuck inside the tip of this complaint device.The outer sheath, tip, inner sheath and the remainder of the device were checked for damage.The additional device that was stuck in the tip was removed.Visual examination revealed kinks to the outer sheath at the nosecone and 37.4cm from the nosecone.Microscopic examination revealed no additional damages.The lock was still in the manufactured position and the stent was still visible under the middle sheath.There was blood in the middle sheath.The introducer sheath was cut open and it was verified that there was no stent stuck in there.Inspection of the remainder of the device, revealed no other damage or irregularities.
Event or Problem Description
It was reported that the stent prematurely deployed.A 6x100x130 eluvia drug-eluting vascular stent system was selected for a percutaneous transluminal angioplasty (pta) of the right superficial femoral artery (sfa) chronic total occlusion (cto).During the procedure, the first 2 stents were delivered successfully.When attempting to deliver the last stent, it deployed directly info the non-bsc sheath.The locking mechanism was still on the thumbwheel.There was no resistance when advancing the device through the sheath.The sheath was removed with the deployed stent in it, and replaced with another one.A new eluvia stent was placed and the procedure was completed.There were no patient complications.

• 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: 8577821
• Report Number: 2134265-2019-04766
• Device Sequence Number: 16692334
• Product Code: NIU
• UDI-Device Identifier: 08714729876601
• UDI-Public: 08714729876601
• Combination Product (Y/N): N
• Initial Reporter State: NV
• 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): 06/10/2019

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 Expiration Date: 03/04/2020
• Device Model Number: 24657
• Device Catalogue Number: 24657
• Device Lot Number: 0022743298
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2019
• Initial Date Received by Manufacturer: 04/22/2019
• Supplement Date Received by Manufacturer: 05/23/2019
• Initial Report FDA Received Date: 05/03/2019
• Supplement Report FDA Received Date: 06/10/2019
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 6FR 45CM TERUMO DESTINATION SHEATH; 6FR 45CM TERUMO DESTINATION SHEATH; 6FR 45CM TERUMO DESTINATION SHEATH