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

Model Number	26924
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/28/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr: returned product consisted of an innova self-expanding stent system with the yellow thumbwheel protector still in the manufactured position.Visual examination of the returned device revealed a kink at the nosecone.The middle sheath was kinked 27.9cm from the distal end of the middle sheath.The distal end of the middle sheath was not touching the proximal end of the tip by approximately 1mm.The stent was not inside the middle sheath and was missing/not returned.Microscopic examination revealed no damages.The thumbwheel was rotated, and the middle sheath started to move proximally as designed.Inspection of the remainder of the device presented no other damage or irregularities.
Event or Problem Description
It was reported that the stent prematurely deployed.A 8x40x130 innova stent was selected for use for a procedure.While trying to advance the innova through tortuous anatomy, the stent began to prematurely deploy.The catheter and stent were removed from the patient, and another stent was used to complete the procedure without incident.There were no patient complications reported.

• 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: 8350827
• Report Number: 2134265-2019-01138
• Device Sequence Number: 183298
• Product Code: NIP
• UDI-Device Identifier: 08714729874171
• UDI-Public: 08714729874171
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 02/19/2019

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: 06/25/2021
• Device Model Number: 26924
• Device Catalogue Number: 26924
• Device Lot Number: 22301234
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/28/2019
• Initial Report FDA Received Date: 02/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1