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

Model Number	26924
Medical Device Problem Codes	Material Deformation (2976); Activation Failure (3270)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/17/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device eval by manufacturer: the returned product consisted of an innova self-expanding stent system.Visual examination revealed that there is a kink to the outer sheath at the nosecone.The handle is partially open.The stent is partially deployed approximately 10mm from the distal end of the middle sheath.Microscopic examination revealed a kink to the inner liner approximately 24mm from the tip.The clip is no longer attached to the handle.The clip and inner liner are twisted.The two locking pins on the clip are bent.There are blue marks on the thumbwheel and the pull rack is damaged approximately 12.5cm from the knob.There is a crack on the thumbwheel.Inspection of the remainder of the device, revealed no other damage or irregularities.
Event or Problem Description
It was reported that the stent was damaged.A 6 x 60 x 130 cm innova self-expanding stent was selected to be implanted in the superficial femoral artery (sfa).During the procedure, the stent was damaged and would not deploy.The device was removed from the patient, and a new innova device was used to complete the procedure.No patient complications were reported and the patient is fine.

• 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: 9191467
• Report Number: 2134265-2019-12377
• Device Sequence Number: 11276380
• Product Code: NIP
• UDI-Device Identifier: 08714729874003
• UDI-Public: 08714729874003
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/15/2019

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: 10/16/2020
• Device Model Number: 26924
• Device Catalogue Number: 26924
• Device Lot Number: 0021265720
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/18/2019
• Initial Report FDA Received Date: 10/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1