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

Model Number	26924
Medical Device Problem Codes	Difficult to Insert (1316); Premature Activation (1484); Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/19/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that premature stent deployment occurred.A 8x40x130 innova self expanding stent was selected for an aortic runoff procedure in the iliac and superficial femoral artery (sfa).The stent system was being loaded into the introducer sheath when resistance was encountered.The physician then withdrew the system and the stent started to deploy inside the sheath.The entire system was removed.The procedure was completed with another of the same device.There were no patient complications and the patient is fine.
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.The outer sheath, tip, inner sheath and the remainder of the device were checked for damage.Visual examination revealed a kink to the outer sheath at the nosecone.The stent was completely outside of the middle sheath.The stent was measured, and it is approximately 40mm long.The middle sheath is no longer sitting on top of the proximal end of the tip.Microscopic examination revealed no additional damages.There was some clear residue on and in the device.The guide catheter used in the procedure was not returned with the device so a test guide catheter was used for functional testing.Per product specification, the device was advanced into a 6f test guide catheter and was unable to pass through.Inspection of the remainder of the device presented no other damage or irregularities.
Event or Problem Description
It was reported that premature stent deployment occurred.A 8x40x130 innova self expanding stent was selected for an aortic runoff procedure in the iliac and superficial femoral artery (sfa).The stent system was being loaded into the introducer sheath when resistance was encountered.The physician then withdrew the system and the stent started to deploy inside the sheath.The entire system was removed.The procedure was completed with another of the same device.There were no patient complications 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: 8755196
• Report Number: 2134265-2019-07424
• Device Sequence Number: 1999071
• Product Code: NIP
• UDI-Device Identifier: 08714729874171
• UDI-Public: 08714729874171
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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,Followup
• Report Date (Section B): 07/19/2019

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: 11/27/2020
• Device Model Number: 26924
• Device Catalogue Number: 26924
• Device Lot Number: 0021432467
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2019
• Initial Date Received by Manufacturer: 06/19/2019
• Supplement Date Received by Manufacturer: 07/12/2019
• Initial Report FDA Received Date: 07/02/2019
• Supplement Report FDA Received Date: 07/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 70 YR