MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MAPLE GROVE INNOVA¿; STENT, SUPERFICIAL FEMORAL ARTERY

Model Number	H74939293084070
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/14/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Device evaluated by mfr: returned product consisted of an innova self-expanding stent delivery system (sds).The outer sheath, middle shaft and the remainder of the device were checked for damage.The outer sheath showed no damage.The mid-shaft showed no damage.A.035 guidewire was inserted into the device and transcended through the device with no hesitations or restrictions.The wheel guard was intact and the pull handle was at the starting position.The stent was returned outside of the device with no damage.Inspection of the remainder of the device, revealed no other damage or irregularities.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause was unable to be determined.(b)(4).
Event or Problem Description
It was reported that the stent inadvertently deployed.A 8 x 40 x 75 innova stent was selected for a procedure in the external iliac.When the stent was loaded onto the wire, it started to deploy.This occurred during introduction outside the patient's body.The stent was removed from the wire and the procedure was completed with a different device.There were no patient complications and the patient was fine.

• Brand Name: INNOVA¿
• Common Device Name: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): BOSTON SCIENTIFIC - MAPLE GROVE; one scimed place; maple grove MN 55311
• MDR Report Key: 6693492
• Report Number: 2134265-2017-06606
• Device Sequence Number: 11071668
• Product Code: NIP
• UDI-Device Identifier: 08714729873815
• UDI-Public: (01)08714729873815(17)20200229(10)20329709
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 06/14/2017

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: 02/29/2020
• Device Model Number: H74939293084070
• Device Catalogue Number: 39293-08407
• Device Lot Number: 20329709
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/14/2017
• Initial Report FDA Received Date: 07/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 88 YR