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

Model Number	26926
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	11/12/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by manufacturer: returned product consisted of an innova self-expanding stent system matching the reported information.The outer sheath, tip, inner sheath and the remainder of the device were checked for damage.Visual and microscopic examination revealed a kink to the outer sheath at the nosecone.The stent was partially deployed approximately 3mm from the middle sheath.Microscopic examination revealed no additional damages.The lock and rack were still in the manufactured position.Inspection of the remainder of the device, revealed no other damage or irregularities.
Event or Problem Description
It was reported that an inadvertent deployment occurred.A 6x150x130 innova self-expanding stent was selected for a procedure in the superficial femoral artery (sfa).During preparation, it was discovered that the stent was inadvertent deployed approximately 1 mm when the package was opened.The device did not enter the patient.The procedure was completed with another innova device.There were no complications to the patient.

• 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: 9378779
• Report Number: 2134265-2019-14500
• Device Sequence Number: 19602366
• Product Code: NIP
• UDI-Device Identifier: 08714729874041
• UDI-Public: 08714729874041
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: P140028
• 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
• Report Date (Section B): 11/26/2019

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: 06/23/2022
• Device Model Number: 26926
• Device Catalogue Number: 26926
• Device Lot Number: 0023998538
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/12/2019
• Initial Report FDA Received Date: 11/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1