MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INNOVA VASCULAR; STENT, SUPERFICIAL FEMORAL ARTERY

Model Number	26924
Medical Device Problem Codes	Premature Activation (1484); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/16/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the stent prematurely deployed.A 6x40x130 innova self expanding stent was selected for a procedure in the subclavian vein (scv).Pre-dilation was performed resulting in a less than 50% stenosed lesion.A non-bsc guidewire and 6 fr access sheath were used and the device was delivered via antegrade approach.It was reported that it was difficult to deliver the device to the lesion, the wire did not have smooth movement.Despite lubricating the device the stent deployed approximately two struts despite the safety lock remaining on.The procedure was completed using another of the same device.No patient complications were reported.
Event or Problem Description
It was reported that the stent prematurely deployed.A 6x40x130 innova self expanding stent was selected for a procedure in the subclavian vein (scv).Pre-dilation was performed resulting in a less than 50% stenosed lesion.A non-bsc guidewire and 6 fr access sheath were used and the device was delivered via antegrade approach.It was reported that it was difficult to deliver the device to the lesion, the wire did not have smooth movement.Despite lubricating the device the stent deployed approximately two struts despite the safety lock remaining on.The procedure was completed using another of the same device.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by manufacturer.Returned product consisted of an innova self-expanding stent system.The outer sheath, tip, inner sheath and the remainder of the device were checked for damage.Visual examination revealed damage to the sheath 82cm from the nosecone.Microscopic examination revealed no additional damages.The stent is outside of the device.The thumbwheel lock is missing and the rack has moved 6mm from the manufactured position.Inspection of the remainder of the device, revealed no other damage or irregularities.Product analysis found damages to the device that may have contributed to the premature deployment and resistance.

• Brand Name: INNOVA VASCULAR
• Common Device Name: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10020907
• Report Number: 2134265-2020-05930
• Device Sequence Number: 2592773
• Product Code: NIP
• UDI-Device Identifier: 08714729873990
• UDI-Public: 08714729873990
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P140028
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2020

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: 04/26/2021
• Device Model Number: 26924
• Device Catalogue Number: 26924
• Device Lot Number: 0022047193
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2020
• Initial Date Received by Manufacturer: 04/16/2020
• Supplement Date Received by Manufacturer: 08/19/2020
• Initial Report FDA Received Date: 05/04/2020
• Supplement Report FDA Received Date: 08/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: RADIFOCUS 35 30CM; RADIFOCUS 35 30CM